A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.

Start Date08 Feb 2023

Sponsor / Collaborator

GSK Plc

CTR20220414 / TerminatedPhase 3

试验专业题目一项评估使用GSK3196165治疗类风湿性关节炎的安全性和疗效的多中心、长期扩展研究

[Translation] A multicenter, long-term extension study evaluating the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis

主要目的：确定中度至重度活动性类风湿性关节炎（RA）受试者接受GSK3196165 90 mg或150 mg每周一次治疗的长期安全性。次要目的：确定GSK3196165的长期疗效。测定GSK3196165对患者报告结局（PRO）的影响。确定GSK3196165的潜在免疫原性。探索性目的：确定GSK3196165对资格确认研究中接受sarilumab或托法替布治疗的受试者的疗效。确定药代动力学（PK）和靶点结合（TE）。确定停止背景MTX/csDMARD治疗的受试者亚群的疗效、安全性和PK。

[Translation]

Primary Objectives: To determine the long-term safety of GSK3196165 90 mg or 150 mg once weekly in subjects with moderately to severely active rheumatoid arthritis (RA). Secondary Objectives: To determine the long-term efficacy of GSK3196165. To determine the effect of GSK3196165 on patient-reported outcomes (PROs). To determine the potential immunogenicity of GSK3196165. Exploratory Objectives: To determine the efficacy of GSK3196165 in subjects treated with sarilumab or tofacitinib in the qualification study. To determine the pharmacokinetics (PK) and target engagement (TE). To determine the efficacy, safety, and PK in the subpopulation of subjects who discontinued background MTX/csDMARD therapy.

Start Date30 Mar 2022

Sponsor / Collaborator

GlaxoSmithKline (China) Investment Co., Ltd.

[+2]

JPRN-jRCT2071210132 / CompletedPhase 1

A single center, single dose, open-label study in healthy Japanese participants to evaluate the safety, tolerability, and pharmacokinetics of otilimab.

Start Date23 Mar 2022

Sponsor / Collaborator-

100 Clinical Results associated with Otilimab

100 Translational Medicine associated with Otilimab

100 Patents (Medical) associated with Otilimab

Literatures (Medical) associated with Otilimab

01 Dec 2023·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2)

Article

Author: Wang, Reena ; Gupta, Anubha ; McInnes, Iain B ; O'Shea, Ciara ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Shelton, Celia ; Saurigny, Didier ; Taylor, Peter C ; van der Heijde, Désirée ; Goode, Christopher ; Weinblatt, Michael E ; Wang, Millie ; Mukherjee, Sumanta ; Smith, Julia E ; Fleischmann, Roy M ; Davies, John ; Takeuchi, Tsutomu ; Bracher, Marguerite ; Atsumi, Tatsuya ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an antigranulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis.

Methods:

Two phase 3, double-blind randomised controlled trials including patients with inadequate responses to methotrexate (contRAst 1) or conventional synthetic/biologic disease-modifying antirheumatic drugs (cs/bDMARDs; contRAst 2). Patients received background csDMARDs. Through a testing hierarchy, subcutaneous otilimab (90/150 mg once weekly) was compared with placebo for week 12 endpoints (after which, patients receiving placebo switched to active interventions) or oral tofacitinib (5 mg two times per day) for week 24 endpoints. Primary endpoint: proportion of patients achieving an American College of Rheumatology response ≥20% (ACR20) at week 12.

Results:

The intention-to-treat populations comprised 1537 (contRAst 1) and 1625 (contRAst 2) patients. Primary endpoint: proportions of ACR20 responders were statistically significantly greater with otilimab 90 mg and 150 mg vs placebo in contRAst 1 (54.7% (p=0.0023) and 50.9% (p=0.0362) vs 41.7%) and contRAst 2 (54.9% (p<0.0001) and 54.5% (p<0.0001) vs 32.5%). Secondary endpoints: in both trials, compared with placebo, otilimab increased the proportion of Clinical Disease Activity Index (CDAI) low disease activity (LDA) responders (not significant for otilimab 150 mg in contRAst 1), and reduced Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Benefits with tofacitinib were consistently greater than with otilimab across multiple endpoints. Safety outcomes were similar across treatment groups.

Conclusions:

Although otilimab demonstrated superiority to placebo in ACR20, CDAI LDA and HAQ-DI, improved symptoms, and had an acceptable safety profile, it was inferior to tofacitinib.

Trial registration numbers:

NCT03980483,NCT03970837.

01 Dec 2023·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3)

Article

Author: Gupta, Anubha ; Bracher, Marguerite ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Saurigny, Didier ; Shelton, Celia ; Goode, Christopher ; Mukherjee, Sumanta ; Wang, Millie ; Smith, Julia E ; Taylor, Peter C ; Takeuchi, Tsutomu ; O'Shea, Ciara ; Wang, Reena ; Atsumi, Tatsuya ; Fleischmann, Roy M ; McInnes, Iain B ; Weinblatt, Michael E ; Davies, John ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an anti-granulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis and an inadequate response to conventional synthetic (cs) and biologic disease-modifying antirheumatic drugs (DMARDs) and/or Janus kinase inhibitors.

Methods:

ContRAst 3 was a 24-week, phase III, multicentre, randomised controlled trial. Patients received subcutaneous otilimab (90/150 mg once weekly), subcutaneous sarilumab (200 mg every 2 weeks) or placebo for 12 weeks, in addition to csDMARDs. Patients receiving placebo were switched to active interventions at week 12 and treatment continued to week 24. The primary end point was the proportion of patients achieving an American College of Rheumatology ≥20% response (ACR20) at week 12.

Results:

Overall, 549 patients received treatment. At week 12, there was no significant difference in the proportion of ACR20 responders with otilimab 90 mg and 150 mg versus placebo (45% (p=0.2868) and 51% (p=0.0596) vs 38%, respectively). There were no significant differences in Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, pain Visual Analogue Scale or Functional Assessment of Chronic Illness Therapy-Fatigue scores with otilimab versus placebo at week 12. Sarilumab demonstrated superiority to otilimab in ACR20 response and secondary end points. The incidence of adverse or serious adverse events was similar across treatment groups.

Conclusions:

Otilimab demonstrated an acceptable safety profile but failed to achieve the primary end point of ACR20 and improve secondary end points versus placebo or demonstrate non-inferiority to sarilumab in this patient population.

Trial registration number:

NCT04134728.

01 Feb 2023·The European respiratory journal

A randomised trial of anti-GM-CSF otilimab in severe COVID-19 pneumonia (OSCAR)

Article

Author: Hatlen, Timothy ; Kostina, Natalia ; Colombo, Hugo ; Bass, Damon ; Terzi, Nicolas ; Criner, Gerard J ; Gupta, Anubha ; Trefilova, Yuliya ; Jarvis, Emily ; Smith, Julia E ; Mukherjee, Sumanta ; de-Miguel-Díez, Javier ; Lakshminarayanan, Divya ; Doreski, Pablo A ; Summers, Charlotte ; Schifano, Lorrie ; Neisen, Jessica ; O'Shea, Ciara ; Sprinz, Eduardo ; Tidswell, Mark A ; Wyncoll, Duncan ; Muñoz-Bermúdez, Rosana ; Shirano, Michinori ; Boughanmi, Hatem ; Martinez-Ayala, Pedro ; Kropotina, Tatiana ; Patel, Jatin ; McEvoy, Charlene ; Schwab, Lee E ; Lacherade, Jean-Claude ; Bocca Ruiz, Xavier ; Meziani, Ferhat ; Hanrott, Kate ; Isaacs, John D ; Layton, Mark ; Beishuizen, Albertus ; Williamson, Russell ; Plantefeve, Gaëtan ; Davy, Katherine ; Shahid, Zainab ; Fernandes, Sofia ; Inman, Dave ; Monchi, Mehran ; François, Bruno ; Cahn, Anthony

Background:

Granulocyte–macrophage colony-stimulating factor (GM-CSF) and dysregulated myeloid cell responses are implicated in the pathophysiology and severity of COVID-19.

Methods:

In this randomised, sequential, multicentre, placebo-controlled, double-blind study, adults aged 18–79 years (Part 1) or ≥70 years (Part 2) with severe COVID-19, respiratory failure and systemic inflammation (elevated C-reactive protein/ferritin) received a single intravenous infusion of otilimab 90 mg (human anti-GM-CSF monoclonal antibody) plus standard care (NCT04376684). The primary outcome was the proportion of patients alive and free of respiratory failure at Day 28.

Results:

In Part 1 (n=806 randomised 1:1 otilimab:placebo), 71% of otilimab-treated patients were alive and free of respiratory failure at Day 28versus67% who received placebo; the model-adjusted difference of 5.3% was not statistically significant (95% CI −0.8–11.4%, p=0.09). A nominally significant model-adjusted difference of 19.1% (95% CI 5.2–33.1%, p=0.009) was observed in the predefined 70–79 years subgroup, but this was not confirmed in Part 2 (n=350 randomised) where the model-adjusted difference was 0.9% (95% CI −9.3–11.2%, p=0.86). Compared with placebo, otilimab resulted in lower serum concentrations of key inflammatory markers, including the putative pharmacodynamic biomarker CC chemokine ligand 17, indicative of GM-CSF pathway blockade. Adverse events were comparable between groups and consistent with severe COVID-19.

Conclusions:

There was no significant difference in the proportion of patients alive and free of respiratory failure at Day 28. However, despite the lack of clinical benefit, a reduction in inflammatory markers was observed with otilimab, in addition to an acceptable safety profile.

News (Medical) associated with Otilimab

10 Jan 2024

·www.fiercepharma.com

JPM24, Day 2: Lilly CEO says competition benefits obesity field; Novavax readies phase 3 combo trial

The J.P. Morgan Healthcare Conference rolled on Tuesday with corporate updates from Eli Lilly and other companies. As the J.P. Morgan Healthcare Conference rolls on in San Francisco, BioNTech, Alnylam, and many other companies updated investors on their businesses heading into 2024. We'll update this page throughout the day; be sure to check back regularly. Tuesday, Jan. 9 at 8:30 p.m. ET AstraZeneca laid out its lofty goals for the end of the decade, which include not only delivering “industry-leading growth” by 2030, but placing in at least “the top-three position” in its five focus areas, chief financial officer Aradhana Sarin said during the company’s presentation. That means AZ is looking to be a top player in oncology, rare diseases, vaccines/immunotherapies, respiratory diseases/immunology plus the field of cardiovascular, renal and metabolism. With a wide geographic footprint and a vast pipeline contributing to “strong growth potential,” the company calls its growth profile “relatively de-risked” compared to peers. As for a more short-term goal, the drugmaker is targeting double-digit growth from 2021 to 2025, a rate that it is “very much on track” to achieve, Sarin said. Even more important than the numbers is the “confidence we have in delivering that growth ambition,” the CFO said. That confidence is backed by the company’s existing products and new indications, plus the previously divulged plan of launching 15 meds by 2030. Release Tuesday, Jan. 9 at 8:09 p.m. ET Novavax is in discussions with Walgreens to add the company's COVID-19 vaccine to the pharmacy's stores for the 2024-25 season, company executives told Fierce Pharma on the sidelines of this year's J.P. Morgan Healthcare Conference. The chain pharmacy elected not to carry the vaccine this season, sticking only with the mRNA options. Meanwhile, Novavax is in the latter half of its first full COVID vaccination season in the U.S., joining Moderna and Pfizer, though its shot remains under emergency use authorization. The Maryland vaccine maker expects that to change, however, with FDA approval tentatively planned for the end of August or early September, according to Chief Operating Officer John Trizzino New CEO John Jacobs is finally coming up for air after a year marked by significant cuts to administrative, manufacturing and R&D costs. The company disclosed that a second round of "focused headcount reductions" would be included in the most recent $300 million cost-cutting plan, announced in November. But he's bullish now, saying the company has $2 billion in cash that's "virtually guaranteed" when considering cash on hand, government contracts and existing receivables. Novavax reported having $666 million in cash as of the end of September 2023. Jacobs says that's enough for the company to solo develop its COVID-flu combination vaccine, slated for a phase 3 trial in humans this year. UPDATED: Tuesday, Jan. 9 at 6:19 p.m. ET Eli Lilly CEO David Ricks threw credit to Novo Nordisk for pursuing GLP-1s for obesity during his Tuesday presentation: “We have tremendous respect for Novo Nordisk and have competed with them for like 100 years and know each other pretty well. “I think here's a case where probably competition spurs us both on to go faster and build out more indications and really take the insight—which, credit to Novo, was to exploit high dose GLPs to pursue weight loss, noticing the separation between A1C and weight loss at the higher doses and we're following them and driving that and I think the world would benefit from that.” The obesity market lends itself to more involvement given the massive demand. Ricks said the two companies are not fighting over a “fixed pie,” but instead using their combined powers to advance the GLP-1 field into addressing other health challenges such as cardiovascular risks, sleep apnea and so on. Ricks said that Novo is the first competitor Lilly thinks about, but another potential threat is the number of larger companies buying into obesity using M&A. “If you're sitting in a boardroom of a large drug company, you're probably asking the CEO, like where's our obesity program? So they're getting one,” Ricks said with a laugh. “Some of them will succeed. Some won't.” First-mover advantage is often crucial in the pharma industry and obesity is no different, especially given the manufacturing scale needed to make a difference in the space, according to Ricks. New entrants will need to push hard on the additional health benefits of their medicines beyond obesity, he added. “We should take them all seriously, and I think sometimes competition discovers new things that we didn't think of, and that's good,” Ricks said. “There is a huge addressable market here. So I'm not saying it'll be two companies that find it all. But probably the benefit of time and experience with this platform really lends to us and a Danish company.” UPDATED: Tuesday, Jan. 9 at 5:40 p.m. ET After more than 25 years in the field, Novo Nordisk has largely proved its obesity thesis, CEO Lars Fruergaard Jørgensen said Tuesday at the J.P. Morgan Healthcare Conference. But even as the potentially multi-billion-dollar market opens up, “we are just getting going,” the CEO said. Not long after Wegovy’s obesity launch, demand outstripped supply, with that inventory uncertainty persisting through 2023. As for the coming year, “I’m very comfortable looking into 2024—and specifically for Wegovy in the U.S.—that we can add significant additional volumes,” Jørgensen explained. That additional capacity for 2024 didn’t come all at once, either, the CEO pointed out. “This is a continued journey of building capacity for the years to come,” Jørgensen said. UPDATED: Tuesday, Jan. 9 at 5:30 p.m. ET GSK expects that Nucala could see around £500 million to £1 billion in additional peak sales in chronic obstructive pulmonary disease (COPD) if a phase 3 readout expected in the second half of 2024 turns out positive, CEO Emma Walmsley said Tuesday. Previously, Nucala’s direct rival, AstraZeneca’s Fasenra, failed two COPD trials. Meanwhile, GSK’s Nucala follow-on candidate, the long-acting IL-5 antibody depemokimab, should deliver phase 3 data in the first half of this year. Walmsley put that drug’s peak sales potential at more than £3 billion. That’s much more than the £1 billion to £2 billion range that the company put out during an investor update in mid-2021. Compared with the 2021 update, the anti-GM-CSF antibody otilimab has lost its place in GSK’s immunology portfolio after disappointing phase 3 results led to its discontinuation in 2022. Taking its place is camlipixant, a chonic cough program that GSK got last year from its $2 billion acquisition of Bellus Health. After the FDA's recent complete response letter for Merck’s rival med gefapixant, GSK believes camlipixant could generate more than £2.5 billion in peak sales. The drug’s phase 3 program is on track to report results in the second half of 2025. UPDATED: Tuesday, Jan. 9 at 4:55 p.m. ET Four years after the arrival of the company’s CEO Paul Hudson, the “new” Sanofi has finally started to take shape. With the goal to become a tech-powered, immunology powerhouse, Sanofi is now in the midst of a “real moment,” Hudson said Tuesday at the J.P. Morgan Healthcare Conference in San Francisco. “It’s been a long time in the making, and we really feel like we’re demonstrating that we’re the new Sanofi,” he said. Much of the company’s momentum will continue to hinge on its Regeneron-partnered megablockbuster Dupixent, which Hudson expects to reel in roughly 13 billion euros in sales in 2024. But while Dupixent will continue to grow “until its end,” Hudson knows the medicine’s patent cliff is looming sometime during the next decade. In turn, Sanofi is going all-in on R&D, with the goal to generate more than 10 billion euros in sales from new medicines by 2030. “This is a very important moment for the company to have multiple shots on goal in massive diseases,” Hudson said. “This is a deck stacked for success.” After declines for its hematology franchise earlier in the decade, Roche is riding the rebound. The company's hemophilia A blockbuster Hemlibra is providing much of the sales firepower, but newer T-cell engagers Lunsumio and Columvi are giving Roche more reasons for optimism. Those two meds are off to strong starts, and Roche is running studies to potentially move them into earlier treatment lines. Also in Roche's hematology portfolio is the lucrative antibody-drug conjugate Polivy. In all, Roche sees its blood-cancer franchise delivering 14% average annual growth through 2026, following sizable sales declines in 2020 and 2021. Story UPDATED: Tuesday, Jan. 9 at 3:37 p.m. ET While 2024 will be “monumental” for Sarepta Therapeutics, the company’s ambitions extend to 2030, when it’s poised to “become a big biotech,” CEO Doug Ingram said at the conference. Last year, the biotech scored an accelerated approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys under a restricted label. Now, Sarepta hopes to expand the approved usage to cover all DMD patients. Despite missing the primary endpoint in a key trial, the company maintains its belief that the data “exceeded the threshold for substantial evidence of effectiveness,” Ingram said. Meanwhile, the FDA is “committed to evaluating a labeling expansion to the fullest extent possible,” according to the CEO’s presentation. The treatment brought in an estimated $200 million in 2023 after its June approval. Mizuho analysts called the sales estimate “better than expected” and believe the “odds are high” for the potential label expansion. Sarepta projected its total 2023 revenue to come in at $945 million, exceeding its previous guidance. Release UPDATED: Tuesday, Jan. 9 at 10:45 a.m. ET After its overwhelming success during the pandemic, Pfizer was knocked down a peg in 2023. Its launches came up short and the company was blindsided by a sudden drop in demand for its pandemic products. After some retooling, the company is set for a “year of execution,” Pfizer CEO Albert Bourla said. “We used to be the stars of the industry for a few years, so the drop really hurts.” The silver lining for the company in 2023 was a record nine FDA approvals for novel products, including two for Abrysvo, though the company has some regrets about the early performance of its RSV vaccine launch. Story The new year brings Merck closer to 2028 when the company will lose patent protection for mega-blockbuster Keytruda. At the J.P. Morgan Healthcare Conference, CEO Rob Davis tried to de-emphasize the impact of the Keytruda cliff by focusing on the company’s pipeline assets, including three antibody-drug conjugates that Merck has in-licensed from Daiichi Sankyo and a Moderna-partnered cancer vaccine. Last January, Merck said its pipeline of oncology prospects could eventually produce $10 billion annually. A year later, Merck has jacked up its oncology portfolio estimate to $20 billion-plus by the middle of the next decade. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. It’s just another year.” Story UPDATED: Tuesday, Jan. 9 at 10:36 a.m. ET As COVID vaccine revenues sink across the board, mRNA specialist BioNTech is turning its attention to its oncology pipeline. This year pledges to be one of “significant execution,” CEO and co-founder Ugur Sahin, M.D., said in a strategic update. The company projects revenues of approximately €3 billion ($3.28 billion) for 2024, mainly driven by its Pfizer-partnered COVID vaccine Comirnaty, which is expected to “remain profitable.” That would be a drop from last year, given that BioNTech has guided for 2023 COVID-19 vaccine sales of €4 billion. Also last year, BioNTech added six new prospects to its oncology pipeline, which now includes a mix of phase 2 and phase 3 assets. Outside of cancer therapies, the company is working on an mRNA-based combination COVID and influenza vaccine alongside Pfizer. BioNTech’s full corporate update will take place later today at 12 p.m. ET. Release Alnylam collected revenues of $1.24 billion in 2023 thanks to its polyneuropathy of hATTR amyloidosis meds Onpattro and Amvuttra, plus its hepatic porphyria therapy Givlaari and primary hyperoxaluria type 1 treatment Oxlumo. The company’s ATTR franchise garnered $913 million, while the two ultra-rare drugs pulled a total of $329 million. Total revenues from Alnylam’s portfolio were up 39% from 2022. The company believes it is on the way toward positioning itself as a “top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry,” CEO Yvonne Greenstreet said in a statement. The RNAi drugmaker will report results from its phase 3 study of its vutrisiran in cardiomyopathy of ATTR amyloidosis early this year. Alnylam will further discuss its financial results and commercial updates at the J.P. Morgan Healthcare Conference today during its presentation at 12:45 p.m. ET. Release

VaccinePhase 3

09 Jan 2023

·www.prnewswire.com

Rheumatoid Arthritis Market is Expected to Showcase Significant Growth in the 7MM at a Minimal CAGR of 1.9% During the Study Period (2019-2032), Predicts DelveInsight

The dynamics of the rheumatoid arthritis market are anticipated to change in the coming years owing to the increasing awareness and expected increase in investment in the R&D activities. Companies like GlaxoSmithKline [Otilimab (MOR103/GSK3196165)], Taisho Pharmaceutical [Ozoralizumab (TS-152)], Aclaris Therapeutics [Zunsemetinib (ATI-450)], Abivax [ABX464], and others with their key candidates are in the late clinical and filing stage. LAS VEGAS, Jan. 9, 2023 /PRNewswire/ -- DelveInsight's Rheumatoid Arthritis Market Insights report includes a comprehensive understanding of current treatment practices, rheumatoid arthritis emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into the 7MM [the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Rheumatoid Arthritis Market Report As per DelveInsight analysis, the rheumatoid arthritis market size in the 7MM was approximately USD 27 billion in 2021. According to the assessment done by DelveInsight, the estimated total rheumatoid arthritis prevalent population in the 7MM was approximately 4. 7 million in 2021. Leading rheumatoid arthritis companies such as Taisho Pharmaceuticals, R-Pharm, GlaxoSmithKline, Aclaris Therapeutics, Pfizer, Abivax, Bristol Myers Squibb, Oscotec/Genosco, Mesoblast, Pfizer Akros Pharma/Japan Tobacco, Abbvie, Horizon Therapeutics, Eli Lilly and Company, Taiho Pharmaceutical, Gilead Sciences, Kiniksa Pharmaceuticals, Istesso, SynAct Pharma, Cyxone, and others are developing novel rheumatoid arthritis drugs that can be available in the rheumatoid arthritis market in the coming years. The promising rheumatoid arthritis therapies in the pipeline include Ozoralizumab (TS-152), Artlegia (Olokizumab), Otilimab (GSK3196165/MOR103), Zunsemetinib (ATI-450), Ritlecitinib (PF-06651600), ABX464, Branebrutinib, Cevidoplenib (SKI-O-703), MPC-300-IV, PF-06650833, JTE -051, ABBV-154, TAS5315, MBS2320, AMT-101, AP1189, Rabeximod (Rob 803), and others. In June 2022, Cyxone received a response from a Type B Pre-IND meeting with the US FDA. The response from the FDA facilitates Cyxone to continue planning the Phase IIb study with Rabeximod in RA. In December 2021, Taisho Pharmaceuticals presented the interim results from a 24-week administration in Phase II/III clinical trial (OHZORA study) of ozoralizumab in adult patients with RA at the annual meeting of the Japanese Society for Clinical Rheumatology and Related Research. Discover which therapies are expected to grab the major rheumatoid arthritis market share @ Rheumatoid Arthritis Market Report Rheumatoid Arthritis Overview Rheumatoid arthritis is a type of autoimmune disease. It happens when our immune system, which is supposed to defend us, malfunctions and starts attacking our own tissues. It causes inflammation in the joint lining (the synovium). As a result, joints may become red, warm, swollen, and painful, which are all symptoms of rheumatoid arthritis. The precise causes of rheumatoid arthritis are still unknown. Because the early signs and symptoms of rheumatoid arthritis are similar to those of many other diseases, it can be difficult to detect in its early stages. There is no single blood test or physical finding that can confirm the diagnosis of rheumatoid arthritis. There is no known cure for rheumatoid arthritis. However, clinical trials of rheumatoid arthritis show that remission of symptoms is more common when rheumatoid arthritis treatment with disease-modifying antirheumatic medicines begins early (DMARDs). Rheumatoid Arthritis Epidemiology Segmentation DelveInsight estimates that there were approximately 4.7 million prevalent cases of rheumatoid arthritis in the 7MM in 2021. Among the EU4 and the UK countries, Germany accounted for the highest number of rheumatoid arthritis cases, whereas France accounted for the lowest cases in 2021 The rheumatoid arthritis market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Prevalent Cases Total Diagnosed Prevalent Cases Gender-specific Prevalent Cases Age-specific Prevalent Cases Severity-specific Prevalent Cases Patients on Targeted Therapies Line-Wise Treated Cases Download the report to understand which factors are driving rheumatoid arthritis epidemiology trends @ Rheumatoid Arthritis Epidemiological Insights Rheumatoid Arthritis Treatment Market Over the last few years, there has been a dramatic improvement in rheumatoid arthritis outcomes as a direct result of paradigm shifts in rheumatoid arthritis treatment. At the moment, the main rheumatoid arthritis treatment options are Medicine (for long-term relief of symptoms and slowing the progression of the condition), Supportive treatments (including physiotherapy and occupational therapy, to help keep the patient mobile and manage any problems related to daily activities), and Surgery (to correct any joint problems that develop over a period of time). Nonsteroidal anti-inflammatory drugs (NSAIDs) are typically used only for symptomatic treatment until a rheumatoid arthritis diagnosis is established because they reduce pain and stiffness in patients but have no effect on disease progression. Moreover, disease-modifying antirheumatic drugs (DMARDs) are used to target inflammation and prevent further joint damage and disease progression. DMARDs are a class of drugs that have been shown to affect the underlying cause of rheumatoid arthritis by reducing immune system overactivity, thereby alleviating pain, swelling, and stiffness and preventing joint changes. DMARDs can be prescribed singly or in combination as an initial part of treatment. Methotrexate is the first-line DMARD agent for the majority of rheumatoid arthritis patients. It has a relatively quick onset of action at therapeutic doses (6-8 weeks), good efficacy, a low toxicity profile, is easy to administer, and is relatively inexpensive. To know more about rheumatoid arthritis guidelines, visit @ Rheumatoid Arthritis Management Rheumatoid Arthritis Pipeline Therapies and Key Companies Artlegia (Olokizumab): R-Pharm TS-152 (Ozoralizumab): Taisho Pharmaceuticals Otilimab (GSK3196165/MOR103): GlaxoSmithKline ATI-450 (Zunsemetinib/CDD-450): Aclaris Therapeutics Branebrutinib: Bristol Myers Squibb LY3462817: Eli Lilly and Company TAS5315: Taiho Pharmaceutical Rabeximod (Rob 803): Cyxone GS-5718: Gilead Sciences KPL-404: Kiniksa Pharmaceuticals MBS2320: Istesso AMT-101: Applied Molecular Transport Dazodalibep (HZN-4920): Horizon Therapeutics Cevidoplenib (SKI-O-703): Genosco/Oscotec HB-AdMSCs: Hope Biosciences ABX464: Abivax MPC-300-IV: Mesoblast PF-06650833: Pfizer JTE 051: Akros Pharma/Japan Tobacco Dekavil (F8IL10): Pfizer/Philogen ABBV-154: AbbVie PF-06651600 (Ritlecitinib): Pfizer AP1189: SynAct Pharma Learn more about the FDA-approved drugs for rheumatoid arthritis @ Drugs for Rheumatoid Arthritis Treatment Rheumatoid Arthritis Market Dynamics The dynamics of the rheumatoid arthritis market is anticipated to change in the future due to the increasing awareness and expected increase in investment in the R&D activities by the leading companies working in the rheumatoid arthritis market space. Moreover, current therapies, such as biological DMARDs, have shown promising results in treating rheumatoid arthritis patients, and market penetration is expected to increase in the future, driving rheumatoid arthritis market growth. Furthermore, there is still a high demand for therapies with a similar efficacy profile to current therapies but a better safety profile and a more patient-friendly RoA. Oral classes, such as JAKi and the upcoming BTKi, are expected to contribute to the rheumatoid arthritis market growth due to patient-friendly RoA. However, several factors are likely to hamper the rheumatoid arthritis market growth. The rheumatoid arthritis market is highly competitive, and new entrants are expected to face some resistance and low uptake because anti-TNFs currently dominate the rheumatoid arthritis market, and the entry of biosimilars will pose significant challenges to new and upcoming treatment options in the rheumatoid arthritis market. In addition, the entry of biosimilars has already begun in the US and EU (i.e., Remicade biosimilars), and as a result, sales value has started to decline. The impact will be more pronounced when biosimilars/ generics of some blockbuster drugs, such as Humira (i.e., 2023 in the US), Xeljanz (i.e., 2025 in the US), will enter the rheumatoid arthritis market, and this will significantly impact the growth of the rheumatoid arthritis market. Scope of the Rheumatoid Arthritis Market Report Therapeutic Assessment: Rheumatoid Arthritis current marketed and emerging therapies Rheumatoid Arthritis Market Dynamics: Rheumatoid Arthritis market drivers and barriers Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies Unmet Needs, KOL's views, Analyst's views, Rheumatoid Arthritis Market Access and Reimbursement Discover more about rheumatoid arthritis drugs in development @ Rheumatoid Arthritis Clinical Trials Table of Contents Related Reports Rheumatoid Arthritis Epidemiology Forecast Rheumatoid Arthritis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted rheumatoid arthritis epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Juvenile Rheumatoid Arthritis Pipeline Juvenile Rheumatoid Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products and the key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Juvenile Rheumatoid Arthritis Market Juvenile Rheumatoid Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key juvenile rheumatoid arthritis companies, including Novartis, AbbVie, Eli Lilly and Company, Sanofi, among others. Psoriatic Arthritis Pipeline Psoriatic Arthritis Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Psoriatic Arthritis Market Psoriatic Arthritis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psoriatic arthritis companies, including Mylan, Celltrion, Pfizer, Amgen, among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market Related Healthcare Blogs Rheumatoid Arthritis Emerging Drugs Knee Osteoarthritis Pipeline Rheumatoid Arthritis Market Scenario Juvenile Idiopathic Arthritis Therapy Market Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Clinical Result

16 Nov 2022

·www.biospace.com

MorphoSys AG Reports First Nine Months and Third Quarter 2022 Financial Results

– Monjuvi® U.S. net product sales of US$ 22.2 million (€ 21.9 million) for the third quarter of 2022 – Presentation of preliminary results from phase 1/2 study of tulmimetostat (CPI-0209) supporting its potential application in a broad array of advanced tumors – Enrollment advances in MANIFEST-2 phase 3 trial for pelabresib in myelofibrosis – € 1,038.1 million in cash and other financial assets as of September 30, 2022 PLANEGG, Germany--(BUSINESS WIRE)-- Conference call and webcast (in English) tomorrow, November 17, 2022, at 2:00pm CET (1pm GMT/8:00am ET) MorphoSys AG (FSE: MOR; NASDAQ: MOR) reports results for the third quarter and the first nine months of 2022. "As we approach the end of this year, I am proud of what we have achieved so far. I want to highlight the progress we have made with the patient enrollment of our pivotal studies for pelabresib and tafasitamab as well as the preliminary phase 1/2 results we released for tulmimetostat suggesting anti-tumor activity across multiple tumors", said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. "We are highly engaged to ensure increasing awareness and use of Monjuvi for appropriate patients with relapsed or refractory diffuse large B-cell lymphoma. Looking ahead we are focused on continued execution and delivering on the pelabresib pivotal study timeline." Monjuvi/Minjuvi® Highlights: Monjuvi (tafasitamab-cxix) U.S. net product sales of US$ 22.2 million (€ 21.9 million) for the third quarter 2022 (Q3 2021: US$ 22.0 million (€ 18.6 million)) and US$ 64.1 million (€ 60.2 million) for first nine months 2022 (9M 2021: US$ 55.5 million (€ 46.4 million)). Minjuvi royalty revenue of € 0.9 million for sales outside of the U.S. in the third quarter 2022 and € 2.3 million for the first nine months of 2022. Conference Data Highlights: New data presented at SOHO conference in September 2022 Data from the ongoing L-MIND study presented at the Society of Hematologic Oncology (SOHO) conference suggests that tafasitamab plus lenalidomide followed by tafasitamab monotherapy provided durable response in patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) treated for at least two years, including six patients on treatment for 5 years or more. Preliminary results of tulmimetostat (CPI-0209) study presented in October 2022 Preliminary results from the ongoing phase 1/2 study of the investigational EZH2 inhibitor tulmimetostat were presented at the ENA Symposium on Molecular Targets and Cancer. Tulmimetostat monotherapy in heavily pretreated patients with advanced cancers showed responses or disease stabilization in five cohorts with evaluable patients. Pelabresib and tafasitamab presentations and posters at ASH in December 2022 MorphoSys will contribute 14 presentations - including four oral presentations - on the investigational BET inhibitor pelabresib and on tafasitamab to the upcoming American Society of Hematology Annual Meeting and Exposition (ASH) from December 10-13, 2022 in New Orleans, Louisiana, USA. Corporate Developments: On August 31, 2022, MorphoSys announced Tim Demuth, M.D., Ph.D. as new Chief Research and Development Officer, following the retirement of Malte Peters, M.D. Tim Demuth started his new role on October 1, 2022. Significant Events After the End of the Third Quarter of 2022: On October 27, 2022, MorphoSys’ license partner GSK provided an update on the ContRAst phase III program for otilimab in moderate to severe rheumatoid arthritis. On November 14, 2022, MorphoSys' license partner Roche disclosed that the GRADUATE studies with gantenerumab in early Alzheimer's disease did not meet the primary endpoint of slowing clinical decline. Financial Results for the Third Quarter of 2022 (IFRS): Total revenues for the third quarter 2022 were € 95.8 million compared to € 41.2 million for the same period in 2021. This increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio. in € million* Q3 2022 Q2 2022 Q3 2021 Q-Q Δ Y-Y Δ Total revenues 95.8 59.4 41.2 61 % > 100% Monjuvi product sales 21.9 21.7 18.6 1 % 18 % Royalties 29.7 22.0 17.0 35 % 75 % Licenses, milestones and other 44.1 15.7 5.6 > 100% > 100% * Differences due to rounding. Cost of Sales: In the third quarter of 2022, cost of sales was € 8.1 million compared to € 7.5 million for the comparable period in 2021. Research and Development (R&D) Expenses: In the third quarter 2022, R&D expenses were € 77.8 million (Q3 2021: € 64.4 million). The increase in R&D expenses is primarily due to higher investments to support the advancement of clinical programs. Selling, General and Administrative (SG&A) Expenses: Selling expenses in the third quarter 2022 were € 23.5 million (Q3 2021: € 32.4 million). The decrease was driven by higher investments in 2021 made into the commercial organization, the first full year after the Monjuvi launch. General and administrative (G&A) expenses amounted to € 15.6 million (Q3 2021: € 19.4 million). The decrease was driven by the transaction costs for the Constellation acquisition which was completed in the third quarter of 2021. Operating Loss: Operating loss amounted to € 29.3 million in the third quarter 2022 (Q3 2021: operating loss of € 82.4 million). Consolidated Net Loss: For the third quarter 2022, consolidated net loss was € 122.9 million (Q3 2021: consolidated net loss of € 112.8 million). Financial Results for the first nine months (IFRS): Revenues for the first nine months of 2022 were € 196.7 million (9M 2021: € 126.7 million). The increase resulted mainly from higher revenues from licenses due to the out-licensing agreements with HI-Bio. Revenues include € 60.2 million from the recognition of Monjuvi product sales in the U.S. Royalties in the first nine months included € 2.3 million from the sale of Minjuvi outside of the U.S. by our partner Incyte and € 68.5 million from Tremfya® sales which is fully passed on to Royalty Pharma. in € million* 9M 2022 9M 2021 Y-Y Δ Total revenues 196.7 126.7 55 % Monjuvi product sales 60.2 46.4 30 % Royalties 70.8 42.4 67 % Licenses, milestones and other 65.6 37.9 73 % * Differences due to rounding. Cost of Sales: For the first nine months of 2022, cost of sales were € 33.2 million compared to € 22.7 million in 2021. The increase was primarily driven by higher sales of Monjuvi in the U.S. and Minjuvi outside of the U.S. R&D Expenses: In the first nine months of 2022, R&D expenses were € 203.8 million compared to € 138.2 million in 2021. The R&D expenses increased primarily due to higher development activity and the inclusion of expenses from the Constellation acquisition since Q3 2021. SG&A Expenses: Selling expenses decreased in the first nine months of 2022 to € 69.4 million compared to € 89.0 million in 2021. The decrease was primarily driven by higher investments made into the commercial organization in 2021, the first full year after the Monjuvi launch. G&A expenses amounted to € 42.6 million compared to € 60.1 million in the first nine months of 2021. The decrease was driven primarily by the transaction costs related to the Constellation and Royalty Pharma agreements in 2021. Operating Loss: Operating loss amounted to € 152.3 million in the first nine months of 2022 compared to an operating loss of € 183.3 million in 2021. Consolidated Net Loss: For the first nine months of 2022, consolidated net loss was € 480.5 million compared to a net loss of € 133.5 million in 2021. Cash and Other Financial Assets: As of September 30, 2022, the Company had cash and other financial assets of € 1,038.1 million compared to € 976.9 million on December 31, 2021. Number of shares: The number of shares issued totaled 34,231,943 on September 30, 2022, no change compared to December 31, 2021. Updated Full Year 2022 Financial Guidance: Amounts in million Current 2022 Financial Guidance issued on Oct. 21, 2022 Previous 2022 Financial Guidance issued on July 26, 2022 2022 Guidance Insights Monjuvi U.S. Net Product Sales Approx. US$ 90m US$ 90m to 110m 100% of Monjuvi U.S. product sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte. Gross Margin for Monjuvi U.S. Net Product Sales 75% to 80% 75% to 80% 100% of Monjuvi U.S. product cost of sales are recorded on MorphoSys’ income statement and related profit/loss is split 50/50 between MorphoSys and Incyte. R&D expenses € 275m to 300m € 275m to 300m SG&A expenses € 150m to 165m € 150m to 165m 53% to 58% of mid-point of SG&A expenses represent Monjuvi U.S. selling costs of which 100% are recorded in MorphoSys’ income statement. Incyte reimburses MorphoSys for half of these selling expenses. Additional information related to 2022 Financial Guidance: Tremfya® royalties will continue to be recorded as revenue without any cost of sales in MorphoSys’ income statement. These royalties, however, will not contribute any cash to MorphoSys as 100% of the royalties will be passed on to Royalty Pharma. MorphoSys anticipates receiving royalties for Minjuvi sales outside of the U.S. MorphoSys does not anticipate any significant cash-accretive revenues from the achievement of milestones in 2022. MorphoSys anticipates sales of commercial and clinical supply of tafasitamab outside of the U.S. to its partner Incyte. Revenue from this supply is recorded in the “Licenses, milestones and other” category in MorphoSys’ income statement. These sales result in a zero gross profit/margin. As such, MorphoSys does not provide guidance for these sales. While R&D expense is anticipated to grow year-over-year due to investments in three pivotal studies, the growth is partially being offset by the consolidation of research/discovery activities. SG&A expense guidance range reflects savings from synergies following the acquisition of Constellation and streamlined commercialization efforts. MorphoSys Group Key Figures (IFRS, end of the third quarter: September 30, 2022) in € million Q3 2022 Q3 2021 Δ 9M 2022 9M 2021 Δ Revenues 95.8 41.2 >100% 196.7 126.7 55 % Product Sales 21.9 18.6 18 % 60.2 46.4 30 % Royalties 29.7 17.0 75 % 70.8 42.4 67 % Licenses, Milestones and Other 44.1 5.6 >100% 65.6 37.9 73 % Cost of Sales (8.1) (7.5) 8 % (33.2) (22.7) 46 % Gross Profit 87.7 33.8 >100% 163.5 104.0 57 % Total Operating Expenses (117.0) (116.1) 1 % (315.8) (287.3) 10 % Research and Development (77.8) (64.4) 21 % (203.8) (138.2) 47 % Selling (23.5) (32.4) (27) % (69.4) (89.0) (22) % General and Administrative (15.6) (19.4) (20) % (42.6) (60.1) (29) % Operating Profit / (Loss) (29.3) (82.4) (64) % (152.3) (183.3) (17) % Other Income 10.6 2.0 >100% 19.8 4.8 >100% Other Expenses (7.5) (1.2) >100% (23.0) (4.6) >100% Finance Income 70.3 (17.0) >(100)% 87.1 99.3 (12) % Finance Expenses (167.5) (55.7) >100% (415.4) (92.4) >100% Income from Reversals of Impairment Losses / (Impairment Losses) on Financial Assets 0.6 0.3 >100% (0.4) 0.6 >(100)% Share of Loss of Associates accounted for using the Equity Method (0.3) — n/a (0.3) — n/a Income Tax Benefit / (Expenses) 0.1 41.2 (100) % 4.1 42.2 (90) % Consolidated Net Profit / (Loss) (122.9) (112.8) 9 % (480.5) (133.5) >100% Earnings per Share, Basic and Diluted (in €) (3.60) (3.30) 9 % (14.07) (4.03) >100% Cash and other financial assets (end of period) 1,038.1 976.9 * 6 % 1,038.1 976.9 * 6 % *Value as of December 31, 2021 MorphoSys will hold its conference call and webcast tomorrow, November 17, 2022, at 2:00pm CET (1:00pm GMT/8:00am EST) to present the results for the third quarter and the first nine months 2022. Participants for the conference call and webcast may pre-register and will receive dedicated dial-in details to easily and quickly access the call: Please dial in 10 minutes before the beginning of the conference. A live webcast and slides will be made available at the Investors section under "Events & Conferences" on MorphoSys' website, and after the call, a slide-synchronized audio replay of the conference will be available at the same location. The statement for the third quarter and the first nine months 2022 (IFRS) are available for download at: About MorphoSys At MorphoSys, we are driven by our mission to give more life for people with cancer. As a global commercial-stage biopharmaceutical company, we use groundbreaking science and technologies to discover, develop, and deliver innovative cancer medicines to patients. MorphoSys is headquartered in Planegg, Germany, and has its U.S. operations anchored in Boston, Massachusetts. To learn more, visit us at and follow us on Twitter and LinkedIn. About Monjuvi (tafasitamab-cxix) Monjuvi® (tafasitamab-cxix) is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP). In the United States, Monjuvi® (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In Europe, Minjuvi® (tafasitamab) received conditional marketing authorization in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT). Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials. Monjuvi® and Minjuvi® are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi® in the U.S., and marketed by Incyte under the brand name Minjuvi® in Europe, the UK and Canada. Tremfya® is a registered trademark of Janssen Biotech, Inc. XmAb® is a registered trademark of Xencor, Inc. Forward Looking Statements This communication contains certain forward-looking statements concerning the MorphoSys group of companies. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that MorphoSys' expectations may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

Clinical ResultFinancial StatementPhase 3Drug ApprovalASH

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 3	AR	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	BR	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	CA	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	CZ	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	HU	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	IN	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	IT	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	MX	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	PH	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019
Rheumatoid Arthritis	Phase 3	PL	GlaxoSmithKline (China) Investment Co., Ltd.	16 May 2019

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04333147 (CTgov)	Phase 3	Rheumatoid Arthritis	2,916	csDMARD(s)+Otilimab (GSK3196165) (Otilimab 90 mg)	rbppdmnijw(klqejkzwmn) = ofqwwjllxn qctuklybry (jzkxgsxnyk, odfupmthyn - ymsxckjber) View more	-	07 Feb 2024
				csDMARD(s)+Otilimab (GSK3196165) (Otilimab 150 mg)	rbppdmnijw(klqejkzwmn) = hrkoedpnvr qctuklybry (jzkxgsxnyk, jpbdxyghhx - aopmchmasg) View more
NCT03980483 (CTgov)	Phase 3	Rheumatoid Arthritis	1,537	GSK3196165 (Otilimab) (GSK3196165 90mg + MTX)	uiurqeaoui(rmhmkmvagy) = ycyzbvtzeh dopmkwlndo (grgskcypep, muattepodz - lmymubivvr) View more	-	25 Oct 2023
				GSK3196165 (Otilimab) (GSK3196165 150mg + MTX)	uiurqeaoui(rmhmkmvagy) = mljenipjkx dopmkwlndo (grgskcypep, lvwhvgqoof - wawlzjrepa) View more
NCT04134728 (ContRAst-3, CTgov)	Phase 3	Rheumatoid Arthritis	550	csDMARD+GSK3196165 (GSK3196165 90mg + csDMARD)	uaeacsfdbr(mmukolcrqd) = txzmndwfds bdspsvsgbp (dbupwriuio, blwepflelp - vleyzoulph) View more	-	17 Jul 2023
				csDMARD+GSK3196165 (GSK3196165 150mg + csDMARD)	uaeacsfdbr(mmukolcrqd) = cqnkzljgls bdspsvsgbp (dbupwriuio, bucyfteszj - xsabrkvnld) View more
NCT03970837 (contRAst 2, Corporate Publications) Manual	Phase 3	Rheumatoid Arthritis	-	Otilimab	nwqzvmyrwx(rriuwdfosa) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 ifvgslstgw (lamuxqiken )	Positive	27 Oct 2022
NCT04134728 (ContRAst-3, Corporate Publications) Manual	Phase 3	Rheumatoid Arthritis	-	otilimab	vnqbnsprpz(zxnyjmebau) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors. dvrlxewczy (iehlxkfvxl )	Negative	27 Oct 2022
				Placebo
NCT04376684 (CTgov)	Phase 2	Severe Acute Respiratory Syndrome	1,156	placebo+sodium chloride (Part 1: Placebo 1)	gpnmewriyl(tabfmdyytv) = ugqswgyufc iqbuuyxunb (tsodrikyja, dhpjgbollb - hlwlpoigig) View more	-	09 Mar 2022
				Otilimab (Part 1: Otilimab 90 mg)	gpnmewriyl(tabfmdyytv) = gchfkzvscg iqbuuyxunb (tsodrikyja, eoxqjouanq - jcptigzegv) View more
NCT02504671 (BAROQUE, ACR2019)	Phase 2	Rheumatoid Arthritis	222	Otilimab 90 mg	vxfsusmdet(lbqtoveagv) = lqijfolxxa oqdtubnwhp (nfstebitrt ) View more	Positive	10 Nov 2019
				Otilimab 180 mg	hdnndjesbi(yolfscqvmu) = anebztrgmv qkxdaxmkph (ednufhbzzg, 22% - 69%) View more
NCT03028467 (CTgov)	Phase 1/2	Rheumatoid Arthritis	15	Placebo+Folic acid+Methotrexate	tznmbqsmfe(vpocyvfaur) = eobrhfasnr wsfzxixgmz (humqjshrey, cqbqvkiwqa - uuraajiscr) View more	-	26 Jun 2019
NCT02504671 (BAROQUE \| phase IIb dose-finding study, CTgov)	Phase 2	Rheumatoid Arthritis	222	placebo+folic acid+MTX+sodium chloride (Placebo)	vandtaaizn(mwsznsrevf) = knyoqtxhku nekilnyvgo (vubwititwq, rxbvsntmkv - asarabxsfu) View more	-	04 Apr 2019
				GSK3196165 (GSK3196165 22.5 mg)	vandtaaizn(mwsznsrevf) = owxcozavku nekilnyvgo (vubwititwq, mkpkhjygjr - hgxacecpfr) View more
NCT02683785 (CTgov)	Phase 2	Osteoarthritis	44	Placebo	bfxpffptpb(stnevdrknd) = jkkhwfuxwt wsktdztzur (feqoltfgby, nphfwgdxcw - egctuvxcob) View more	-	14 Dec 2018

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