An Adaptive, Dose-Ranging, Phase 2 Study of Eltrekibart Given Alone or in Combination With Mirikizumab for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis

The main purpose of this study is to determine the safety and efficacy of eltrekibart and mirikizumab in adult participants with moderately to severely active ulcerative colitis (UC).

Start Date10 Oct 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06626165 / RecruitingPhase 4IIT

Mirikizumab Therapy is Effective for Patients with Moderate to Severe Ulcerative Colitis Patients Whose Geboes Score Grade is ≥3.2) on Endoscopic Biopsy

The goal of this study is to confirm that Mirikizumab therapy may provide clinical, endoscopic, and histopathologic improvements in patients with moderate to severe UC refractory to maintenance therapy when high neutrophilic infiltration in epithelium of the colonic mucosa (Geboes score Grade ≥3.2) on endoscopic biopsy is found.

Start Date20 Jul 2024

Sponsor / Collaborator-

NCT06475729 / Active, not recruitingPhase 1

A Bioequivalence Study of Subcutaneous Injections of Citrate-Free Mirikizumab Solution Using a 1-mL Autoinjector and an Investigational 2-mL Autoinjector in Healthy Participants

The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.
Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

Start Date24 Jun 2024

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Mirikizumab

100 Translational Medicine associated with Mirikizumab

100 Patents (Medical) associated with Mirikizumab

212

Literatures (Medical) associated with Mirikizumab

01 Jan 2025·JOURNAL OF ETHNOPHARMACOLOGY

Dehydrocorydaline attenuates myocardial ischemia-reperfusion injury via the FoXO signalling pathway: A multimodal study based on network pharmacology, molecular docking, and experimental study

Article

Author: Chen, Keji ; Renfeng, Li ; Keji, Chen ; Zucheng, Shang ; Hua, Qu ; Lin, Guosheng ; Li, Mengfan ; Daxin, Chen ; Zhi, Guo ; Zikai, Yu ; Wenwen, Yang ; Qu, Hua ; Li, Renfeng ; Shen, Aling ; Meizhu, Wu ; Guosheng, Lin ; Guo, Zhi ; Mengfan, Li ; Chen, Daxin ; Hongzheng, Li ; Yang, Wenwen ; Aling, Shen ; Shang, Zucheng ; Yingdong, Lu ; Wu, Meizhu ; Li, Hongzheng ; Lu, Yingdong ; Fu, Changgeng ; Yu, Zikai ; Changgeng, Fu

ETHNOPHARMACOLOGICAL RELEVANCE:

Dehydrocorydaline (DHC), an active component of Corydalis yanhusuo (Y.H. Chou & Chun C. Hsu) W.T. Wang ex Z.Y. Su & C.Y. Wu (Papaveraceae), exhibits protective and pain-relieving effects on coronary heart disease, but the underlying mechanism still remains unknown.

AIM OF THE STUDY:

Network pharmacology and experimental validation both in vivo and in vitro were applied to assess whether DHC can treat myocardial ischemia-reperfusion injury (MIRI) by regulating the forkhead box O (FoxO) signalling pathway to inhibit apoptosis.

MATERIALS AND METHODS:

DHC and MIRI targets were retrieved from various databases. Molecular docking and microscale thermophoresis (MST) determined potential binding affinity. An in vivo mouse model of MIRI was established by ligating the left anterior descending coronary artery. C57BL/6N mice were divided into sham, MIRI, and DHC (intraperitoneal injection of 5 mg/kg DHC) groups. Haematoxylin and eosin, Masson, and immunohistochemical stainings verified DHC treatment effects and the involved signalling pathways. In vitro, H9c2 cells were incubated with DHC and underwent hypoxia/reoxygenation. TUNEL, JC-1, and reactive oxygen species stainings and western blots were used to explore the protective effects of DHC and the underlying mechanisms.

RESULTS:

Venny analysis identified 120 common targets from 121 DHC and 23,354 MIRI targets. DHC exhibited high affinity for CCND1, CDK2, and MDM2 (<-7 kcal/mol). In vivo, DHC attenuated decreases in left ventricular ejection fraction and fractional shortening, reduced infarct sizes, and decreased cTnI and lactate dehydrogenase levels. In vitro, DHC alleviated apoptosis and oxidative stress in the hypoxia/reoxygenation model by attenuating ΔΨm disruption; reducing the production of reactive oxygen species; upregulating Bax and CCND1 via the FoxO signalling pathway, as well as cleaved-caspase 8; downregulating the apoptosis-associated proteins Bcl-2, Bid, cleaved-caspase 3, and cleaved-caspase 9; and promoting the phosphorylation of FOXO1A and MDM2.

CONCLUSION:

By upregulating the FoxO signaling pathway to inhibit apoptosis, DHC exerts a cardioprotective effect, which could serve as a potential therapeutic option for MIRI.

31 Dec 2024·mAbs

Antibodies to watch in 2024

Article

Author: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

01 Dec 2024·GASTROENTEROLOGY

Comparative Efficacy of Advanced Therapies for Management of Moderate-to-Severe Ulcerative Colitis: 2024 American Gastroenterological Association Evidence Synthesis

Review

Author: Singh, Siddharth ; Limketkai, Berkeley N ; Ananthakrishnan, Ashwin N ; Haydek, John P ; Murad, M Hassan ; Scott, Frank I ; Agrawal, Manasi ; Loftus, Edward V

BACKGROUND & AIMS:

We performed an updated systematic review and network meta-analysis to inform the 2024 American Gastroenterological Association (AGA) Clinical Guidelines on the management of moderate-to-severe ulcerative colitis (UC).

METHODS:

We searched multiple electronic databases through November 21, 2023, to identify randomized controlled trials in adults with moderate-to-severe UC, comparing different advanced therapies (tumor necrosis factor antagonists, vedolizumab, sphingosine-1-phosphate receptor modulators, interleukin 12/23 or selective interleukin 23 antagonists, and Janus kinase [JAK] inhibitors) against placebo or another active comparator. Our primary outcomes were induction and maintenance of clinical remission, and our secondary outcome was endoscopic improvement. We performed a network meta-analysis using a frequentist approach and applied Grading of Recommendations, Assessment, Development and Evaluation (GRADE) to appraise certainty of evidence.

RESULTS:

After excluding JAK inhibitors as potential first-line treatment (in accordance with the United States Food and Drug Administration), low-certainty evidence supports clinically important benefit with infliximab, ozanimod, risankizumab, and guselkumab over adalimumab and mirikizumab for achieving remission with induction therapy in biologically naïve patients with moderate-to-severe UC, with risankizumab and ozanimod being ranked the highest for induction of clinical remission. With the inclusion of JAK inhibitors as first-line therapy, upadacitinib was more efficacious compared with all other medications except ozanimod and risankizumab, with low- to moderate-certainty evidence. In patients with prior biologic exposure, upadacitinib, tofacitinib, and ustekinumab were ranked highest for achieving remission.

CONCLUSIONS:

Using Grading of Recommendations, Assessment, Development and Evaluation to appraise quality of evidence, this updated network meta-analysis will be used to inform comparative efficacy and positioning of advanced therapies for the treatment of biologic-naïve and biologic-exposed patients with moderate-to-severe UC.

104

News (Medical) associated with Mirikizumab

22 Nov 2024

·www.prnewswire.com

Johnson & Johnson seeks U.S. FDA approval for subcutaneous induction regimen of TREMFYA® (guselkumab) in ulcerative colitis, a first for an IL-23 inhibitor

Following recent U.S. FDA approval of TREMFYA® for adults with moderately to severely active ulcerative colitis (UC), this submission underscores its potential to be the only IL-23 inhibitor that offers choice of subcutaneous or intravenous induction in UC Submission is supported by the Phase 3 ASTRO study, which achieved the primary endpoint of clinical remission at Week 12 and met all secondary endpoints in adults with moderately to severely active UC SPRING HOUSE, Pa., Nov. 22, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a subcutaneous (SC) induction regimen of TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active UC. The filing is supported by data from the Phase 3 ASTRO study of TREMFYA® SC induction therapy in adults with UC and builds upon the recent U.S. approval of TREMFYA® in this indication. The Phase 3 ASTRO study met its primary endpoint, achieving a statistically significant and clinically meaningful results for clinical remission at Week 12 with a 400 mg SC induction dose of TREMFYA® administered at Weeks 0, 4, and 8. All secondary endpoints, including endoscopic improvement and histologic-endoscopic mucosal improvement (HEMI), were also met. Safety data from ASTRO were consistent with the safety findings from the QUASAR program. Results from the ASTRO study are planned for presentation at upcoming medical meetings.1 "With the ASTRO study in UC and the GRAVITI study in Crohn's disease (CD), we are focused on delivering versatility and options for administration of treatment for people with inflammatory bowel disease (IBD). TREMFYA is the first IL-23 inhibitor to potentially offer a fully SC induction and maintenance regimen, which if approved, can provide choice and simplicity for patients and providers," stated Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson Innovative Medicine. "The ASTRO results add to the compelling data generated from the QUASAR program in UC and build on the promise of TREMFYA in the treatment of IBD as we look to transform outcomes for patients." TREMFYA® is the first and only approved, dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC.2,3,4,5,6 TREMFYA® received U.S. FDA approval in September 2024 for the treatment of adult patients with moderately to severely active UC and is currently administered via an IV induction regimen, followed by a SC maintenance regimen. The approval was supported by data from the Phase 3 QUASAR study evaluating the efficacy and safety of TREMFYA® in adults with moderately to severely active UC.7 An application seeking approval of TREMFYA® for the treatment of adults with moderately to severely active CD has been submitted in the U.S., and applications seeking approval for both CD and UC have been submitted in Europe. ABOUT THE ASTRO STUDY (NCT05528510) ASTRO is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. Patients were randomized 1:1:1 to receive TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC induction at Weeks 0, 4 and 8, followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in ASTRO (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 QUASAR program that established the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active UC.8 ABOUT THE QUASAR PROGRAM (NCT04033445) QUASAR is a randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 2b/3 program designed to evaluate the efficacy and safety of TREMFYA® in adults with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or JAK inhibitors (tofacitinib). QUASAR included a Phase 2b dose-ranging induction study, a confirmatory Phase 3 induction study, and a Phase 3 randomized withdrawal maintenance study. In the induction study, patients received either TREMFYA® 200 mg or placebo by IV infusion at Weeks 0, 4, and 8. In the maintenance study, patients received a SC maintenance regimen of either TREMFYA® 200 mg q4w, TREMFYA® 100 mg q8w, or placebo.9 ABOUT THE GRAVITI STUDY (NCT05197049) GRAVITI is a randomized, double-blind, placebo-controlled, treat-through Phase 3 study to evaluate the efficacy and safety of TREMFYA® SC induction therapy (400 mg at Weeks 0, 4, and 8) in adults with moderately to severely active Crohn's disease who experienced an inadequate response or failed to tolerate conventional therapy (i.e., corticosteroids or immunomodulators) or biologic therapy (TNF antagonists or vedolizumab). Patients received TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 200 mg SC q4w; or TREMFYA® 400 mg SC at Weeks 0, 4, and 8 followed by TREMFYA® 100 mg SC q8w; or placebo. The maintenance doses in GRAVITI (200 mg SC q4w and 100 mg SC q8w) are the same as those evaluated in the Phase 3 GALAXI 2 and GALAXI 3 studies that evaluated the efficacy and safety of IV induction followed by SC maintenance therapy in patients with moderate to severely active Crohn's disease).10 ABOUT ULCERATIVE COLITIS Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.11 ABOUT CROHN'S DISEASE Crohn's disease is one of the two main forms of inflammatory bowel disease, which affects an estimated three million Americans.12 Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors. Symptoms of Crohn's disease can vary, but often include abdominal pain and tenderness, frequent diarrhea, rectal bleeding, weight loss, and fever.13 ABOUT TREMFYA® (guselkumab) Developed by Johnson & Johnson, TREMFYA® is the first approved fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source by blocking IL-23 and binding to CD64 (a receptor on cell that produce IL-23). Findings for dual-acting are limited to in vitro studies that demonstrate guselkumab binds to CD64, which is expressed on the surface of IL-23 producing cells in an inflammatory monocyte model. The clinical significance of this finding is not known. TREMFYA® is a prescription medicine approved in the U.S. to treat: adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light). adults with active psoriatic arthritis. adults with moderately to severely active ulcerative colitis.2 TREMFYA® is approved Europe, Canada, Japan, and a number of other countries for the treatment of adults with moderate-to-severe plaque psoriasis and for the treatment of adults with active psoriatic arthritis. Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA®. For more information, visit: . IMPORTANT SAFETY INFORMATION What is the most important information I should know about TREMFYA® (guselkumab)? TREMFYA® is a prescription medicine that may cause serious side effects, including: Serious Allergic Reactions. Stop using TREMFYA® and get emergency medical help right away if you develop any of the following symptoms of a serious allergic reaction: Infections. TREMFYA® may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with TREMFYA® and may treat you for TB before you begin treatment with TREMFYA® if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with TREMFYA®. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: Do not take TREMFYA® if you have had a serious allergic reaction to guselkumab or any of the ingredients in TREMFYA®. Before using TREMFYA®, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about TREMFYA®?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with TREMFYA®. are pregnant or plan to become pregnant. It is not known if TREMFYA® can harm your unborn baby. Pregnancy Registry: If you become pregnant during treatment with TREMFYA®, talk to your healthcare provider about registering in the pregnancy exposure registry for TREMFYA®. You can enroll by visiting , by calling 1-877-311-8972, or emailing [email protected]. The purpose of this registry is to collect information about the safety of TREMFYA® during pregnancy. are breastfeeding or plan to breastfeed. It is not known if TREMFYA® passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of TREMFYA®? TREMFYA® may cause serious side effects. See "What is the most important information I should know about TREMFYA®?" The most common side effects of TREMFYA® include respiratory tract infections, headache, injection site reactions, joint pain (arthralgia), diarrhea, stomach flu (gastroenteritis), fungal skin infections, herpes simplex infections, and bronchitis. These are not all the possible side effects of TREMFYA®. Call your doctor for medical advice about side effects. Use TREMFYA® exactly as your healthcare provider tells you to use it. Please read the full Prescribing Information, including Medication Guide, for TREMFYA® and discuss any questions that you have with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1-800-FDA-1088. Dosage Forms and Strengths: TREMFYA® is available in a 100 mg/mL prefilled syringe and One-Press patient-controlled injector for subcutaneous injection, a 200 mg/2 mL prefilled syringe and prefilled pen (TREMFYA® PEN) for subcutaneous injection, and a 200 mg/20 mL (10 mg/mL) single dose vial for intravenous infusion. ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JNJInnovMed. Janssen Research & Development, LLC, Janssen Biotech, Inc. and Janssen-Cilag International NV are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc., Janssen-Cilag International NV nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 Data on file. 2 Atreya R, Abreu MT, Krueger JG, et al. Guselkumab, an IL-23p19 subunit-specific monoclonal antibody, binds CD64+ myeloid cells and potentially neutralizes IL-23 produced from the same cells. Poster presented at: 18th Congress of the European Crohn's and Colitis Organization (ECCO); March 1-4, 2023; Copenhagen, Denmark. Poster P504. 3 Kreuger JG, Eyerich K, Kuchroo VK. Il-23 past, present, and future: a roadmap to advancing IL-23 science and therapy. Front Immunol. 2024; 15:1331217. doi:10.3389/fimmu.2024.1331217 4 TREMFYA® Prescribing Information. Available at: Accessed October 2024. 5 Skyrizi® [Prescribing Information]. North Chicago, IL: AbbVie, Inc. 6 Omvoh™ [Prescribing Information]. Indianapolis, IN: Eli Lilly and Company. 7 TREMFYA® Prescribing Information. Available at: Accessed October 2024. 8 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (ASTRO). Identifier: NCT05528510. . Accessed October 2024. 9 National Institutes of Health: Clinicaltrials.gov. A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis (QUASAR). Identifier: NCT04033445. . Accessed October 2024. 10 National Institutes of Health: Clinicaltrials.gov. A study of guselkumab subcutaneous therapy in participants with moderately to severely active Crohn's disease (GRAVITI). Identifier: NCT05197049. Available at: . Accessed October 2024. 11 Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: . Accessed April 2024. 12 Crohn's & Colitis Foundation. Overview of Crohn's disease. Available at: . Accessed October 2024. 13 Crohn's & Colitis Foundation. Signs and symptoms of Crohn's disease. Available at . Accessed October 2024. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 3Drug Approval

13 Nov 2024

·www.globenewswire.com

Oruka Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Successful go-public transaction and over $475 million raised this year provides cash runway through multiple clinical inflection points ORKA-001 non-human primate (NHP) pharmacokinetic and in vitro potency data, presented at EADV in September, further support and derisk the program Strong execution allowed for acceleration of clinical timelines for both ORKA-001 and ORKA-002, as previously announced MENLO PARK, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported third quarter 2024 financial results and provided a corporate update. “We had a highly eventful third quarter which included going public, closing on over $475 million in proceeds across two transactions and continuing to progress our very promising co-lead programs,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We are excited to soon transition to a clinical stage company and show the potential of our programs to raise the bar on what is possible in psoriatic disease.” Third Quarter Business and Pipeline Updates Corporate Oruka consummated its go-public transaction and began trading on the Nasdaq under the ticker ORKA.The Company raised over $475 million, including a $275 million private placement previously announced in April that closed concurrently with the merger and an additional $200 million private placement shortly thereafter from a group of new and existing investors. ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka plans to initiate a Phase 1 trial of ORKA-001 in the first quarter of 2025, which was accelerated from the first half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the second half of 2025 and initial efficacy data in psoriasis patients in the second half of 2026.Data presented at the European Academy of Dermatology and Venereology (EADV) Congress showed that ORKA-001 has a half-life in NHP of more than 30 days, over three times longer than risankizumab and one of the longest NHP half-lives observed for an extended half-life antibody. In addition, the data showed that ORKA-001 binds to a similar epitope as risankizumab and displays similar binding affinity and potency across a variety of in vitro assays.These findings support the potential for ORKA-001 to achieve extended dosing intervals of once every six months or even once a year while maintaining high antibody exposures and further derisk its development path. ORKA-002: a novel half-life extended IL-17A/F monoclonal antibody Oruka plans to initiate a Phase 1 trial of ORKA-002 in the third quarter of 2025, which was accelerated from the second half of 2025. The Company expects to share interim data from the first-in-human trial in healthy volunteers, including initial pharmacokinetic data, in the first half of 2026.A precursor antibody to ORKA-002 showed a half-life in NHP of approximately 20 days, double that seen with bimekizumab, supporting the potential to achieve significantly longer dosing intervals than currently marketed agents targeting IL-17. This extended half-life could enable a dosing interval of once every four to six months for ORKA-002. Third Quarter 2024 Financial Results Cash Position: As of September 30, 2024, Oruka had available cash and cash equivalents of $410.9 million. Net cash used in operating activities was $27.8 million for the third quarter of 2024. The Company expects this cash to provide runway through 2027. Research and Development (R&D) expenses: R&D expenses totaled $25.7 million for the third quarter of 2024. This expense includes $7.8 million of non-cash stock-based compensation. During the third quarter of 2024, the Company incurred $11.8 million and $4.1 million on the development of ORKA-001 and ORKA-002, respectively. General and Administrative (G&A) expenses: G&A expenses totaled $3.8 million for the third quarter of 2024. This expense includes $2.4 million of personnel-related costs, including $1.2 million of non-cash stock-based compensation related to equity awards to employees and service providers, and $1.3 million for professional, consulting, and other costs to operate a public company and support R&D activities. Other income (expense): Other income, net for the third quarter of 2024 was $0.8 million. Interest earned on the Company’s investment in money market funds was $1.3 million for the third quarter of 2024, partly offset by interest expense of $0.5 million on convertible notes before their conversion to common stock. Net loss: Net loss totaled $28.6 million for the third quarter of 2024, which includes non-cash stock-based compensation of $9.0 million. Shares Outstanding: Oruka has approximately 55.1 million shares of the Company’s Common Stock and Common Stock equivalents issued and outstanding, including shares of Common Stock underlying pre-funded warrants and Series A and Series B non-voting convertible preferred stock. About Oruka Therapeutics Oruka Therapeutics is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice a year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. For more information, visit www.orukatx.com and follow Oruka on LinkedIn. Forward Looking Statements Certain statements in this press release, other than purely historical information, may constitute “forward-looking statements” within the meaning of the federal securities laws, including for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements relating to Oruka’s expectations, hopes, beliefs, intentions or strategies regarding the future of its pipeline and business including, without limitation, Oruka’s ability to achieve the expected benefits or opportunities with respect to ORKA-001 and ORKA-002, including timelines to clinical and data release milestones, the potency, binding affinity, efficacy and antibody exposures of ORKA-001, including vis-à-vis risankizumab, the potential half-life of ORKA-001 and ORKA-002 and their potential dosing intervals, and Oruka’s cash runway. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Oruka will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Oruka's control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those uncertainties and factors described under the heading “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in Oruka’s most recent filings with the Securities and Exchange Commission, including its Quarterly Reports on Form 10-Q. Should one or more of these risks or uncertainties materialize, or should any of Oruka’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth therein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements in this press release, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein. Oruka does not undertake or accept any duty to make any updates or revisions to any forward-looking statements. Investor Contact: Alan Lada (650)-606-7911 alan.lada@orukatx.com ORUKA THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) (unaudited) September 30, February 6, Assets2024 2024 Current assets: Cash and cash equivalents$410,875 $— Subscription receivables — 1 Prepaid expenses and other current assets 2,074 Total current assets 412,949 1 Property and equipment, net 160 — Operating lease right-of-use assets 938 — Other non-current assets 43 — Total assets$414,090 $1 Liabilities, Convertible Preferred Stock and Stockholders’ Equity Current liabilities: Accounts payable$2,145 $— Accrued expenses and other current liabilities 1,710 — Operating lease liability, current 146 — Related party common stock warrant liability 7,681 — Related party accounts payable and current liabilities 6,357 — Total current liabilities 18,039 — Operating lease liability, non-current 842 — Total liabilities 18,881 — Commitments and contingencies Preferred stock 52,841 — Stockholders’ equity: Preferred stock 2,931 — Common stock 35 — Additional paid-in capital 397,345 1 Accumulated deficit (57,943) — Total stockholders’ equity 342,368 1 Total liabilities, convertible preferred stock and stockholders’ equity$414,090 $1 ORUKA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except share and per share data)(unaudited) Three Months EndedSeptember 30, 2024 Period fromFebruary 6, 2024(Inception) toSeptember 30, 2024Operating expenses Research and development(1)$25,691 $49,557 General and administrative(1) 3,758 8,248 Total operating expenses 29,449 57,805 Loss from operations (29,449) (57,805)Other income (expense) Interest income 1,330 1,330 Interest expense (504) (1,468)Total other income (expense), net 826 (138)Net loss and comprehensive loss$(28,623) $(57,943)Net loss per share attributable to common stockholders, basic and diluted$1.46 $6.08 Net loss per share attributable to Series A non-voting convertible preferred Stockholders, basic and diluted$1,461.10 $6,077.25 Net loss per share attributable to Series B non-voting convertible preferred Stockholders, basic and diluted$121.76 $506.44 Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 15,013,655 7,765,381 Weighted-average shares used in computing net loss per share attributable to Series A non-voting convertible preferred stockholders, basic and diluted 477 184 Weighted-average shares used in computing net loss per share attributable to Series B non-voting convertible preferred stockholders, basic and diluted 49,191 19,015 (1) Amounts include non-cash stock based compensation expense as follows (in thousands): Three Months EndedSeptember 30, 2024 Period fromFebruary 6, 2024(Inception) toSeptember 30, 2024 Research and development$7,772 $8,310 General and administrative 1,229 1,459 Total$9,001 $9,769

Financial StatementPhase 1Clinical Result

07 Nov 2024

·www.prnewswire.com

Spyre Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Continued execution towards expected milestones across portfolio, with SPY001 on-track for interim Phase 1 data by year-end 2024, and SPY002 on-track for initiation of first-in-human trials in the fourth quarter of 2024 Presented new data on SPY003, a potential best-in-class half-life extended anti-IL-23 antibody, demonstrating robust preclinical potency and a greater than three-fold increase in non-human primate half-life compared to risankizumab Accelerated expected initiation of first-in-human trial for SPY003 to the first quarter of 2025 $414 million of cash, cash equivalents, and marketable securities as of September 30, 2024, with expected runway well into 2027, through multiple clinical readouts WALTHAM, Mass., Nov. 7, 2024 /PRNewswire/ -- Spyre Therapeutics, Inc. ("Spyre" or the "Company") (NASDAQ:SYRE), a clinical-stage biotechnology company utilizing best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches to target improved efficacy and convenience in the treatment of inflammatory bowel disease ("IBD"), today announced its third quarter 2024 financial results and provided program and corporate updates. "With the recent preclinical updates on SPY003, we have now delivered preclinical data supporting potent, half-life extended molecules across the Spyre portfolio. Our next-generation antibodies targeting α4β7, TL1A, and IL-23 all have best-in-class potential as monotherapies and provide multiple chances to deliver paradigm-changing efficacy as combination therapies," said Cameron Turtle, DPhil., Chief Executive Officer. "Our continued execution against our program milestones, at or ahead of schedule, puts Spyre on the cusp of a series of value-creating catalysts over the next few quarters, beginning with our expected SPY001 healthy volunteer interim data by the end of this year." Development Pipeline Overview and Update The Company's approach combines best-in-class antibody engineering, rational therapeutic combinations, and precision immunology with the goal of maximizing efficacy, safety, and convenience of its IBD treatments under development. IBD is a chronic condition characterized by inflammation within the gastrointestinal tract, including two main disorders: ulcerative colitis ("UC") and Crohn's disease ("CD"). In the United States, it is estimated that approximately 2.4 million individuals are diagnosed with IBD. The Company has four programs in nonclinical and clinical development, three of which are targets in IBD validated by third parties. The fourth program is a novel, undisclosed target. The Company is also researching rational combinations of its therapeutic antibody product candidates to target IBD. All three validated targets offer the potential for safe and effective treatment of UC and CD, with infrequent, subcutaneous maintenance dosing as a monotherapy or in combination. SPY001 – a highly potent and selective investigational anti-α4β7 monoclonal antibody engineered with half-life extension technology and formulated for high concentration to maximize induction exposure and potential remission rates, and to enable infrequent, subcutaneous maintenance dosing. In June 2024, the Company announced the initiation of dosing of healthy volunteers in its first-in-human ("FIH") trial of SPY001. The Phase 1 trial is a double blind, placebo-controlled trial expected to enroll approximately 56 healthy volunteers, consisting of at least five single-ascending dose (SAD) cohorts and two multi-ascending dose (MAD) cohorts. Additional cohorts may be added to the study to evaluate pharmacokinetics in healthy volunteers of various ethnicities to facilitate subsequent global clinical trials. Interim data from this Phase 1 trial are expected by the end of 2024. The Company expects pharmacokinetic data to demonstrate proof of concept for SPY001, with modeling of potential human half-life of 35 to 40 days translating to an every-eight-week or every-twelve-week subcutaneous maintenance dosing interval. In October 2024, updated preclinical data for SPY001 were presented at the United European Gastroenterology Week ("UEGW") Congress, including comparable potency and selectivity to the vedolizumab epitope, as well as head-to-head non-human primate ("NHP") pharmacokinetic data showing an updated half-life of 22 days, a greater than three-fold increase relative to vedolizumab*. These data further support our target human half-life for SPY001 of more than 35 days, predicted by allometric scaling. SPY002 – a program with two highly potent, half-life extended, anti-TL1A investigational monoclonal antibody candidates with potential best-in-class binding affinity. The Company believes TL1A has emerged as one of the most promising targets in IBD and broader immunology indications. The Company has nominated two lead SPY002 development candidates which bind both TL1A monomers and trimers, have in vitro subnanomolar potency, and have preclinical data supporting pharmacokinetic half-lives that potentially exceed all clinical-stage TL1A antibodies. The 28-day GLP toxicity studies in NHPs were completed, demonstrating a favorable safety profile with the highest dose level evaluated as the no-observed-adverse-effect-level ("NOAEL") for both SPY002 candidates. The Company expects to begin FIH trials of both SPY002 candidates in the fourth quarter of 2024, with healthy volunteer interim data expected in the first half of 2025. If successful, the Company expects one SPY002 candidate would then advance into further clinical development. In October 2024, preclinical data for both SPY002 development candidates were presented at UEGW demonstrating superior or comparable in vitro potency to first-generation anti-TL1As, as well as a pharmacokinetic half-life of 24 days in NHPs, which represents a two to three-fold increase compared to these same first-generation anti-TL1As. SPY003 – a highly potent and selective investigational monoclonal antibody targeting the p19 subunit of IL-23, engineered with half-life extension technology. In October 2024, preclinical data for SPY003 were presented for the first time at UEGW, demonstrating comparable potency to risankizumab*, as well as a pharmacokinetic half-life of 30 days in NHPs, which represents a greater than three-fold increase compared to risankizumab. These data also demonstrated that SPY003 exhibits high selectivity and affinity for IL-23 and potently inhibits downstream cellular signaling. The Company accelerated the expected initiation of FIH trials to the first quarter of 2025. The Company nominated its potential best-in-class development candidate in June 2024 and is currently progressing through IND-enabling studies. Data from the Phase 3 SEQUENCE trial of risankizumab versus ustekinumab in Crohn's disease, as well as recent data from the Phase 3 VIVID-1 trial of mirikizumab versus ustekinumab, validate the Company's targeting of the p19 subunit as it demonstrated superiority to targeting the p40 subunit common to IL-12 and IL-23 in those studies. Rational Combinations – the Company plans to investigate combinations of our proprietary antibodies in nonclinical studies and clinical trials in order to evaluate whether combination therapy can potentially lead to best-in-class efficacy in IBD, with less frequent dosing. In October 2024, preclinical data for SPY130 and SPY230 were presented at UEGW, demonstrating enhanced efficacy and pharmacodynamics with SPY003 in combination with SPY001 and with SPY002. The Company expects to initiate a Phase 2 clinical trial in 2025 that is intended to include each of our rational combinations, as well as all three of our lead monotherapy programs. Recent Corporate Updates In October 2024, the Company announced the appointment of Sheldon Sloan, M.D., M. Bioethics, as Chief Medical Officer. Dr. Sloan's 25+ years of experience in both large pharmaceutical and small biotech companies, featuring an extensive track record of program leadership in the field of Inflammation and Immunology, will be invaluable to guide the Company as it advances its potentially best-in-class IBD portfolio. *In this press release, comparisons to vedolizumab and risankizumab used synthesized comparator antibodies. Third Quarter 2024 Financial Results Cash Position: As of September 30, 2024, Spyre had available cash, cash equivalents, and marketable securities of $414.2 million. Net cash used in operating activities was $29.4 million for the third quarter of 2024. Research and Development (R&D) expenses: R&D expenses totaled $44.7 million for the third quarter of 2024 and $24.7 million for the third quarter of 2023. The increase was primarily driven by nonclinical and clinical development, personnel-related, and manufacturing expenses for the Company's IBD pipeline, offset partially by lower antibody discovery costs. General and Administrative (G&A) expenses: G&A expenses totaled $10.6 million for the third quarter of 2024 and $8.6 million for the third quarter of 2023. The increase was driven by higher personnel-related expenses, offset partially by lower expenses from legacy Aeglea activities. Other income (expense): Other expense totaled $13.6 million for the third quarter of 2024 primarily driven by a $18.7 million change in fair value of the contingent value right liability partially offset by $5.2 million of interest earned on the Company's cash and marketable securities. For the third quarter of 2023, other expense totaled $21.8 million, primarily driven by a $25.4 million non-cash forward contract liability expense related to an increase in fair value of the underlying Series A Preferred Stock between June 30, 2023 and the forward contract's settlement on July 7, 2023. Net Loss: Net loss totaled $69.0 million and $40.1 million for the third quarters of 2024 and 2023, respectively, which includes non-cash stock compensation expense of $13.1 million and $4.8 million for the third quarters of 2024 and 2023, respectively. About Spyre Therapeutics Spyre Therapeutics is a clinical-stage biotechnology company that aims to create next-generation of inflammatory bowel disease (IBD) products by combining best-in-class antibody engineering, rational therapeutic combinations, and precision medicine approaches. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. For more information, please visit . Safe Harbor / Forward Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical fact are forward-looking statements. These forward-looking statements include statements regarding the Company's future results of operations and financial position, business strategy, including the Company's potential success of developing therapeutics for IBD, the sufficiency of the Company's funding to support the development of its assets, the length of time that the Company believes its existing cash resources will fund its operations, its market size, its potential growth opportunities, its nonclinical and future clinical development activities, clinical trial designs and related regulatory feedback, submission of investigational new drug ("IND") applications and foreign equivalents and further clinical evaluation of therapeutic combinations, the potential efficacy and safety profile of its product candidates, the potential therapeutic benefits and economic value of its product candidates, the timing and results of nonclinical studies and clinical trials, including the commencement of FIH and Phase 2 trials, the timing of data and whether the data demonstrate proof of concept, and the Company's planned regulatory activities including filing of INDs to support development and potential commercialization of product candidates. The words "believe," "may," "will," "potentially," "estimate," "continue," "anticipate," "predict," "target," "intend," "could," "would," "should," "project," "plan," "expect," the negatives of these terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including the expected or potential impact of macroeconomic conditions, including U.S. elections inflationary pressures, rising interest rates, general economic slowdown or a recession, changes in monetary policy, the prospect of a shutdown of the U.S. federal government, volatile market conditions, financial institution instability, as well as geopolitical instability, including the ongoing military conflict in Ukraine, conflict in Israel and surrounding areas, and geopolitical tensions in China on the Company's operations, the potential impacts of the BIOSECURE Act bill if passed into law and those risks described in the Company's Quarterly Reports on Form 10-Q, Annual Reports on Form 10-K, as well as in other filings and reports that the Company makes from time to time with the Securities and Exchange Commission. Moreover, the Company operates in a very competitive and rapidly changing environment, and new risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. In light of these risks, uncertainties, and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. The Company undertakes no obligation to update publicly any forward-looking statement for any reason after the date of this press release to conform these statements to actual results, to reflect changes in the Company's expectations, or otherwise, except as required by law. You should read press release with the understanding that the Company's actual results, levels of activity, performance, events, outcomes, and the timing of results and outcomes, and other circumstances may be materially different from what the Company expects. SOURCE Spyre Therapeutics, Inc. 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Phase 1Executive ChangeFinancial StatementPhase 3Phase 2

100 Deals associated with Mirikizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D11123	Mirikizumab	-	DB14910

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Ulcerative colitis, active moderate	EU	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	IS	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	LI	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active moderate	NO	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	EU	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	IS	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	LI	Eli Lilly & Co.	26 May 2023
Ulcerative colitis, active severe	NO	Eli Lilly & Co.	26 May 2023
Colitis, Ulcerative	JP	Eli Lilly & Co.	27 Mar 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	NDA/BLA	US	Eli Lilly & Co.	30 Apr 2024
Crohn Disease	NDA/BLA	EU	Eli Lilly & Co.	30 Apr 2024
Pediatric Crohn's Disease	Phase 3	US	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	JP	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	AT	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	BE	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	BR	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	CA	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	FR	Eli Lilly & Co.	13 Mar 2024
Pediatric Crohn's Disease	Phase 3	IL	Eli Lilly & Co.	13 Mar 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04232553 (VIVID-2, Company_Website) Manual	Not Applicable	Crohn Disease	-	Mirikizumab	atntpryngl(uvertdpkos) = ekpnmslbqo vyrfutsdqp (bhysdtttyl ) View more	Positive	28 Oct 2024
NCT03519945 \| NCT03518086 \| NCT03524092 (Literature) Manual	Not Applicable	Colitis, Ulcerative	868	Mirikizumab (week 52 responders)	jhduzsozwh(xoebyvaicy) = wbrujxammg uyfjwtscyp (kiqzrhctdh ) View more	Positive	25 Oct 2024
				Mirikizumab (week 52 remitters)	jhduzsozwh(xoebyvaicy) = innxddvsur uyfjwtscyp (kiqzrhctdh ) View more
LUCENT-3 (Pubmed \| Inflamm Bowel Dis)	Not Applicable	Colitis, Ulcerative Maintenance	868	Mirikizumab	fhvqfidzkt(gnvqftfzvk) = opportunistic infection (1.8%), hepatic disorders (3.2%), cerebrocardiovascular events (1.5%), and malignancy (0.3%) akardzyhyn (omooidssyo ) View more	Positive	25 Oct 2024
NCT03926130 (VIVID-1, NEWS) Manual	Phase 3	Crohn Disease	-	Mirikizumab	kdegzxpokx(ljilkcspym) = zwhvfgyvrw hrdrpejtbz (kpjoijadpl ) View more	Positive	15 Oct 2024
				Stelara (ustekinumab)	kdegzxpokx(ljilkcspym) = srjwakeizy hrdrpejtbz (kpjoijadpl ) View more
UEGW	Not Applicable	Ulcerative colitis, active moderate	-	Mirikizumab 300mg IV	dhoaakhgtq(xhprooxcuf) = frkoyeymgw hiyriubfup (tiqqntiqgs ) View more	-	13 Oct 2024
				Placebo	dhoaakhgtq(xhprooxcuf) = miqxqsjxea hiyriubfup (tiqqntiqgs ) View more
UEGW	Not Applicable	Crohn Disease	-	Mirikizumab 900mg intravenously at weeks 0, 4, and 8, then 300mg subcutaneously every 4 weeks (Q4W) from W12 to W52	lweagsueaj(gehhlxomfb) = xurolpiveo mttijemiji (whkrrpilqz )	-	13 Oct 2024
				Placebo	lweagsueaj(gehhlxomfb) = kikqsbhoru mttijemiji (whkrrpilqz )
UEGW	Not Applicable	Crohn's disease, active moderate	-	Mirikizumab	xjsidavbbs(vefuasgoqn) = vaojuwhxsc uzwtfpdsua (smlspgqdvd )	-	13 Oct 2024
UEGW	Not Applicable	Ulcerative colitis, active severe	-	Mirikizumab 300mg IV every 4 weeks	hzghrlkljs(txhuinhjaq) = gnumushkmj athvnuffin (iwfrocffnd )	-	13 Oct 2024
				Placebo	hzghrlkljs(txhuinhjaq) = cbbpedtngr athvnuffin (iwfrocffnd )
NCT03926130 (VIVID-1, UEGW)	Phase 3	Crohn's disease, active moderate	62	Mirikizumab	jgtryupzuj(jctehsssfs) = ttqxjjmmdr jlrhtmqoub (jqjaqasthr )	Positive	13 Oct 2024
NCT03519945 (LUCENT-3, UEGW)	Phase 3	Colitis, Ulcerative Maintenance	-	Mirikizumab	guncnxiqrw(riqpegmvft) = 1.5% qcrwtrlwpi (ilrevjwryh ) View more	Positive	13 Oct 2024
				Placebo

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