A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with RO7790121 in participants with moderately to severely active Crohn's disease (CD).

Start Date12 May 2025

Sponsor / Collaborator

Roche Holding AG

[+1]

CTRI/2025/03/082924

/ Not yet recruitingPhase 3

A phase III, multicenter, double-blind, placebo-controlled study to assess the efficacy and safety of induction therapy with RO7790121 in patients with moderately to severely active ulcerative colitis - Ametrine 2

Start Date20 Apr 2025

Sponsor / Collaborator

Roche Products (India) Pvt Ltd.

CTRI/2025/03/082923

/ Not yet recruitingPhase 3

A Phase III, multicenter, double-blind, placebo-controlled, treat-through study to assess the efficacy and safety of induction and maintenance therapy with RO7790121 in patients with moderately to severely active ulcerative colitis - Ametrine I

Start Date20 Apr 2025

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+1]

100 Clinical Results associated with Afimkibart

100 Translational Medicine associated with Afimkibart

100 Patents (Medical) associated with Afimkibart

Literatures (Medical) associated with Afimkibart

02 Mar 2022·Inflammatory bowel diseasesQ2 · MEDICINE

Antitumor Necrosis Factor-like Ligand 1A Therapy Targets Tissue Inflammation and Fibrosis Pathways and Reduces Gut Pathobionts in Ulcerative Colitis

Q2 · MEDICINE

Article

Author: Ye, Zhan ; Zhang, Jenny ; Danese, Silvio ; Li, Xingpeng ; Hassan-Zahraee, Mina ; Chandra, Deepa E ; Hung, Kenneth E ; Neelakantan, Srividya ; Hyde, Craig L ; Quan, Jie ; Klopocka, Maria ; Romatowski, Jacek ; Raha, Nancy ; Scherl, Ellen J ; Ziemek, Daniel ; Baniecki, Mary Lynn ; Longman, Randy ; Allegretti, Jessica R ; Lepsy, Christopher ; Vincent, Michael S ; Karlsson, Fridrik ; Xi, Li ; Schoenbeck, Uwe

Abstract:

Background:

The first-in-class treatment PF-06480605 targets the tumor necrosis factor-like ligand 1A (TL1A) molecule in humans. Results from the phase 2a TUSCANY trial highlighted the safety and efficacy of PF-06480605 in ulcerative colitis. Preclinical and in vitro models have identified a role for TL1A in both innate and adaptive immune responses, but the mechanisms underlying the efficacy of anti-TL1A treatment in inflammatory bowel disease (IBD) are not known.

Methods:

Here, we provide analysis of tissue transcriptomic, peripheral blood proteomic, and fecal metagenomic data from the recently completed phase 2a TUSCANY trial and demonstrate endoscopic improvement post-treatment with PF-06480605 in participants with ulcerative colitis.

Results:

Our results revealed robust TL1A target engagement in colonic tissue and a distinct colonic transcriptional response reflecting a reduction in inflammatory T helper 17 cell, macrophage, and fibrosis pathways in patients with endoscopic improvement. Proteomic analysis of peripheral blood revealed a corresponding decrease in inflammatory T-cell cytokines. Finally, microbiome analysis showed significant changes in IBD-associated pathobionts, Streptococcus salivarius, S. parasanguinis, and Haemophilus parainfluenzae post-therapy.

Conclusions:

The ability of PF-06480605 to engage and inhibit colonic TL1A, targeting inflammatory T cell and fibrosis pathways, provides the first-in-human mechanistic data to guide anti-TL1A therapy for the treatment of IBD.

01 Nov 2021·Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological AssociationQ1 · MEDICINE

Anti-TL1A Antibody PF-06480605 Safety and Efficacy for Ulcerative Colitis: A Phase 2a Single-Arm Study

Q1 · MEDICINE

Article

Author: Scherl, Ellen J ; Schoenbeck, Uwe ; Banfield, Christopher ; Li, Gang ; Vincent, Michael S ; Neelakantan, Srividya ; Ye, Zhan ; Chandra, Deepa E ; Rath, Natalie ; Peeva, Elena ; Hung, Kenneth E ; Klopocka, Maria ; Romatowski, Jacek ; Hassan-Zahraee, Mina ; Allegretti, Jessica R ; Lepsy, Christopher ; Danese, Silvio

BACKGROUND & AIMS:

An immune component of inflammatory bowel disease is up-regulated tumor necrosis factor-like ligand 1A (TL1A). Anti-TL1A antibodies such as PF-06480605, a fully human immunoglobulin G1 monoclonal antibody, may have therapeutic potential.

METHODS:

This Phase 2a, multicenter, single-arm, open-label study (TUSCANY) evaluated safety, tolerability, efficacy, pharmacokinetics, and immunogenicity in PF-06480605-treated participants with moderate to severe ulcerative colitis (UC). Participants received 500 mg intravenous PF-06480605 every 2 weeks, 7 doses total, with a 3-month follow-up period. Primary safety and efficacy endpoints were the incidence of adverse events (AEs) and week 14 endoscopic improvement (EI) (Mayo endoscopic subscore = 0 or 1), respectively. Secondary endpoints included total soluble TL1A (free/drug-bound) (sTL1A), incidence of anti-drug and neutralizing antibodies, PF-06480605 concentrations, and changes in fecal calprotectin and high-sensitivity C-reactive protein. Histology was assessed at week 14.

RESULTS:

The study enrolled 50 participants; 42 completed. Of 109 treatment-emergent AEs, 18 were treatment-related. The most common AEs were UC disease exacerbation and arthralgia (6 participants each). Four serious AEs, no deaths, and no malignancies were reported. Week 14 EI was observed in a statistically significant proportion of participants (38.2% [uniformly minimum-variance unbiased estimator, per protocol population]). Minimal histologic disease was observed after treatment (Robarts Histopathology Index ≤5: 33.3%; Geboes Index ≤3.2: 47.6%). sTL1A increase over time from baseline indicated sustained target engagement. Forty-one participants (82%) tested positive for anti-drug antibodies and 5 (10%) for neutralizing antibodies.

CONCLUSIONS:

PF-06480605 demonstrated an acceptable safety profile and statistically significant EI in participants with moderate to severe UC, warranting further study in a larger participant cohort. Tissue histopathology analyses support this conclusion.

TRIAL REGISTRATION NUMBER:

https://clinicaltrials.gov/NCT02840721.

The AAPS journal

Determination of Anti-drug Antibody Affinity in Clinical Study Samples Provides a Tool for Evaluation of Immune Response Maturation

Article

Author: Lepsy, Christopher ; Joyce, Alison ; You, Zhiping ; Shea, Christopher ; Gorovits, Boris

Abstract:

Characterization of clinical anti-drug antibody (ADA) responses to biotherapeutics can be important to understanding the consequences of immunogenicity. ADA are expected to be polyclonal, with composition and affinities that evolve over time. Measuring ADA binding affinity can be complicated by the polyclonal nature of response, residual drug in sample, and low ADA levels. We developed a novel workflow to determine the apparent ADA affinity (KD) against a monoclonal antibody biotherapeutic, PF-06480605. An affinity capture elution pre-treatment step was used to isolate ADA and remove residual drug interference from samples. Solution-phase equilibrium incubation was performed using drug and sample ADA as variable and fixed binding interactants, respectively. Unbound ADA concentration was measured using a Singulex Erenna ligand-binding assay (LBA) method. Apparent ADA KD values were calculated using a custom R Shiny algorithm. KD values determined for ADA positive samples showed good correlation with other immunogenicity parameters, including titers and neutralizing antibody (NAb) activity with a general increase in affinity over time, indicative of a maturing immune response. Time of onset of high affinity responses (KD < 100 pM) varied between patients, ranging from 16 to 24 weeks. Antibody responses appeared monophasic at earlier time points, trending towards a biphasic response with a variable transition time and general increase in proportion of high affinity ADA over time. Herein, we provide a novel, sensitive bioanalytical method to determine the KD of ADA in clinical samples. The observed decrease in ADA KD is consistent with evidence of a maturing immune response.Graphical Abstract

News (Medical) associated with Afimkibart

15 Apr 2025

·www.prnewswire.com

Takeda's ENTYVIO Continues Growth Trajectory in Ulcerative Colitis and Crohn's Disease | DelveInsight

With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 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 Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. 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 . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Drug ApprovalPhase 3Immunotherapy

24 Feb 2025

·endpts.com

Sanofi, Teva bolster case for IBD drug with Phase 2 data, despite potential competition

Sanofi and Teva’s inflammatory bowel disease candidate could make €1 billion ($1.05 billion) a year by 2032, Leerink analysts said on Sunday. The blockbuster projection comes after the partners shared updated Phase 2b data from the anti-TL1A drug, dubbed duvakitug. The trial had a positive topline readout in December, earlier than was anticipated. But the new results, which were shared in a Saturday release , show “further evidence of efficacy and safety across all predefined subgroups,” the Leerink analysts said. Duvakitug produced responses in IBD patients who had previously been treated with advanced therapies (ATs) such as biologics, as well as those who hadn’t. In particular, 36% of AT-experienced ulcerative colitis patients who got the 900 mg dose achieved clinical remission, representing a 29% improvement over placebo. Just over half the AT-naïve patients also hit remission at that dose, yielding a 26% difference from placebo. In the Crohn’s disease cohort, 48% of AT-experienced patients given the 900 mg dose had an endoscopic response, representing a 44% improvement over placebo. Endoscopic responses were measured via the Simple Endoscopic Score for Crohn’s Disease, which considers ulcer size and surface area, among other factors. Clinical remission was measured per the modified Mayo Score, which looks at symptoms like stool frequency and rectal bleeding. The endoscopic response rate was 47% for AT-naïve patients on the same dose, good for a 25% difference from placebo. Sanofi and Teva plan to start a Phase 3 trial later this year. The French drugmaker spent €469 million ($500 million) upfront to license duvakitug from Teva back in October 2023. Teva could get up to $1 billion in milestones, split across $600 million for Phase 3 initiations and $400 million for launches. Sanofi will be responsible for commercialization in most markets, including the US, while Teva will lead in Europe, Israel and certain other countries. But the sell-side’s blockbuster forecasts should perhaps be taken with a grain of salt. Two other anti-TL1A drugs are ahead of duvakitug in the clinic and they offer less frequent dosing regimens — once every four weeks versus once every two weeks. These are Roche’s RVT-3101 ( acquired from Roivant) and Merck’s MK-7240, which it bought from Prometheus Biosciences in a deal worth $10.8 billion . Both drugs are already in Phase 3 development. Editor’s Note: This article was updated to clarify that RVT-3101 now belongs to Roche.

Clinical ResultPhase 3Phase 2Acquisition

10 Feb 2025

·investor.roivant.com

Roivant Reports Financial Results for the Third Quarter Ended December 31, 2024, and Provides Business Update

BASEL, Switzerland and LONDON and NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) today reported its financial results for the third quarter ended December 31, 2024, and provided a business update. Brepocitinib to be developed in third indication, cutaneous sarcoidosis (CS), an orphan indication with high unmet need; Phase 2 study initiation expected in second quarter of calendar year with topline data in second half of calendar year 2026 IMVT-1402 development is rapidly progressing with six Investigational New Drug (IND) applications cleared and pivotal studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis (D2T RA) initiated Batoclimab topline results from pivotal trial in myasthenia gravis (MG) and initial results from period 1 of trial in chronic inflammatory demyelinating polyneuropathy (CIDP) expected by March 31, 2025 Progress in ongoing LNP litigation, with the summary judgment phase in the Moderna case taking place across the second and third quarters of calendar year 2025 and a jury trial scheduled for September 2025 Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement “Roivant has broadened our clinical pipeline with the newly announced trial of brepocitinib in cutaneous sarcoidosis. As with dermatomyositis and non-infectious uveitis, brepocitinib has the potential to be a first-in-class agent for CS and expands the treatment options for patients suffering from an indication with high unmet need,” said Matt Gline, CEO of Roivant. “We also look forward to announcing multiple significant study outcomes this year including for batoclimab in MG, CIDP and TED, and for brepocitinib in dermatomyositis. 2025 is a year of harvest for Roivant.” Recent Developments Immunovant:In January 2025, Immunovant announced a $450 million private placement with participation from a U.S.-based healthcare focused investor, a large mutual fund complex, and Roivant, bringing Roivant’s basic ownership up to approximately 57%.Endocrinology ProgramImmunovant recently initiated the first potentially registrational trial of IMVT-1402 in adult participants with GD who are hyperthyroid despite antithyroid drug (ATD) treatment. This study builds on the batoclimab proof-of-concept data presented in 2024, which suggest the potential for deep IgG reduction in the treatment of GD for patients who are not well controlled on ATDs.Rheumatology ProgramImmunovant recently initiated a potentially registrational trial of IMVT-1402 in adult participants with active, anti-citrullinated protein autoantibody (ACPA) positive difficult-to-treat rheumatoid arthritis. The trial includes IMVT-1402’s higher dose (600 mg) as recent in-class data suggest that deeper ACPA reduction correlated with better clinical improvement in ACPA+ RA patients treated with an FcRn inhibitor. Priovant: In February 2025, Priovant announced a Phase 2 study of the safety and efficacy of brepocitinib in adults with cutaneous sarcoidosis. Cutaneous sarcoidosis marks the third indication for brepocitinib and continues the strategy to develop the drug in orphan indications with high unmet need. There are 30,000 to 50,000 patients in the US affected by cutaneous sarcoidosis with no approved therapies. The trial is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Genevant: The Pfizer / BioNTech Markman hearing was held in December 2024. Roivant: Roivant reported consolidated cash, cash equivalents, restricted cash and marketable securities of approximately $5.2 billion at December 31, 2024, not including a one-time regulatory milestone of $75 million received in January for the approval of VTAMA in atopic dermatitis and $113 million of external capital raised in Immunovant’s January private placement.In December 2024, Roivant announced Kinevant’s Phase 2 study of namilumab failed to show treatment benefit in patients with chronic active pulmonary sarcoidosis. Kinevant is discontinuing further development of namilumab for the treatment of sarcoidosis. Major Upcoming Milestones Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of ten indications by March 31, 2026. Neurology ProgramImmunovant intends to report topline results from the pivotal trial of batoclimab in MG by March 31, 2025. Results from this trial are expected to inform a decision regarding next steps for batoclimab in MG and inform the design of a potentially registrational program for IMVT-1402 in MG, which Immunovant expects to initiate following the disclosure of the batoclimab data in MG.Results from period one of the trial evaluating batoclimab in CIDP continue to be expected by March 31, 2025. Those results, as well as observations drawn from public disclosures of other studies in CIDP, are expected to inform a potentially registrational program for IMVT-1402 in CIDP, which Immunovant expects to initiate following the disclosure of the batoclimab CIDP data.Endocrinology ProgramImmunovant plans to announce additional data from the batoclimab proof-of-concept study in GD including 6-month, treatment-free remission data designed to further articulate potential for IMVT-1402 in GD. These data are expected in the summer of 2025.Topline results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves' ophthalmopathy, continue to be expected in the second half of calendar year 2025, along with a decision whether to pursue marketing authorization for batoclimab in TED. Data from this trial may also inform the IMVT-1402 program in GD. Priovant plans to report topline data from the ongoing Phase 3 trial of brepocitinib in DM in the second half of calendar year 2025 and topline data from the ongoing Phase 3 trial of brepocitinib in NIU in the first half of calendar year 2027.Priovant’s Phase 2 trial of brepocitinib in cutaneous sarcoidosis is expected to begin in the second quarter of calendar year 2025; topline results are expected in the second half of calendar year 2026. Pulmovant plans to report topline data from the ongoing Phase 2 trial of mosliciguat in pulmonary hypertension associated with interstitial lung disease in the second half of calendar year 2026. Genevant litigation against Moderna continues to progress with summary judgment phase scheduled for second and third quarter of calendar year 2025; Moderna jury trial scheduled for September 2025. Third Quarter Ended December 31, 2024 Financial Summary Cash Position and Marketable Securities As of December 31, 2024, the Company had consolidated cash, cash equivalents, restricted cash, and marketable securities of approximately $5.2 billion. Research and Development Expenses Research and development (R&D) expenses increased by $33.4 million to $141.6 million for the three months ended December 31, 2024, compared to $108.1 million for the three months ended December 31, 2023. This increase was primarily driven by increases in program-specific costs of $26.2 million, personnel-related expenses of $3.9 million, and share-based compensation of $2.8 million. Within program-specific costs, the increase of $26.2 million was primarily driven by an increase in expense of $29.1 million related to the anti-FcRn franchise, partially offset by a decrease in expense of $5.7 million related to RVT-3101, which was sold to Roche in December 2023. Non-GAAP R&D expenses were $131.2 million for the three months ended December 31, 2024, compared to $100.2 million for the three months ended December 31, 2023. General and Administrative Expenses General and administrative (G&A) expenses increased by $13.4 million to $141.5 million for the three months ended December 31, 2024, compared to $128.2 million for the three months ended December 31, 2023. This increase largely resulted from an increase in share-based compensation expense of $25.0 million, primarily due to the long-term equity incentive awards granted in July 2024 pursuant to the 2024 Senior Executive Compensation Program. This increase was partially offset by a decrease in personnel-related expenses of $15.9 million, primarily due to higher expense in the three months ended December 31, 2023 related to a special one-time cash retention bonus award granted to employees, following approval in December 2023. Non-GAAP G&A expenses were $71.1 million for the three months ended December 31, 2024, compared to $82.6 million for the three months ended December 31, 2023. Income (loss) from discontinued operations, net of tax Income from discontinued operations, net of tax was $327.0 million for the three months ended December 31, 2024 and reflects the gain on sale of subsidiary interests resulting from the sale of our entire equity interest in our majority-owned subsidiary, Dermavant, to Organon in October 2024, partially offset by Dermavant’s net losses. Loss from discontinued operations, net of tax was $58.5 million for the three months ended December 31, 2023, representing the financial results of Dermavant during this period. (Loss) income from continuing operations, net of tax Loss from continuing operations, net of tax was $208.9 million for the three months ended December 31, 2024, compared to income from continuing operations, net of tax of approximately $5.1 billion for the three months ended December 31, 2023. On a basic and diluted per common share basis, loss from continuing operations, net of tax was $0.22 for the three months ended December 31, 2024. On a basic and diluted per common share basis, income from continuing operations, net of tax was $6.44 and $6.10, respectively, for the three months ended December 31, 2023. Non-GAAP loss from continuing operations, net of tax was $143.7 million for the three months ended December 31, 2024, compared to $138.0 million for the three months ended December 31, 2023. Notes to non-GAAP financial measures: (1) Represents non-cash share-based compensation expense. (2) Represents non-cash depreciation and amortization expense. (3) Represents a one-time gain on the sale of Telavant net assets to Roche in December 2023 and a gain on the achievement of a one-time milestone in June 2024. (4) Represents the unrealized loss (gain) on equity investments in unconsolidated entities that are accounted for at fair value with changes in value reported in earnings. (5) Represents the change in fair value of liability instruments, which is non-cash and primarily includes the unrealized (gain) loss relating to the measurement and recognition of fair value on a recurring basis of certain liabilities. (6) Represents the one-time gain on deconsolidation of subsidiaries. (7) Represents the estimated tax effect of the adjustments. Investor Conference Call InformationRoivant will host a live conference call and webcast at 8:00 a.m. ET on Monday, February 10, 2025, to report its financial results for the third quarter ended December 31, 2024, and provide a corporate update. To access the conference call by phone, please register online using this registration link. The presentation and webcast details will also be available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events. The archived webcast will be available on Roivant’s website after the conference call. About RoivantRoivant is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, www.roivant.com. Roivant Forward-Looking StatementsThis press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act. Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors. Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Contacts: InvestorsKeyur Parekhkeyur.parekh@roivant.com MediaStephanie Leestephanie.lee@roivant.com Print Page Email Alerts RSS Feeds IR Contacts

Phase 2Phase 3Financial StatementPhase 1Clinical Result

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Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	United States	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	China	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	Australia	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	Canada	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	Colombia	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	France	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	Poland	Roche Holding AG	12 May 2025
Crohn Disease	Phase 3	United Kingdom	Roche Holding AG	12 May 2025
Crohn's disease, active moderate	Phase 3	Canada	F. Hoffmann-La Roche Ltd.	26 Mar 2025
Crohn's disease, active moderate	Phase 3	Serbia	F. Hoffmann-La Roche Ltd.	26 Mar 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05107492 (CTgov)	Phase 1	Inflammatory Bowel Diseases	12	PF-06480605 (PF-06480605 450mg)	kvihhmveac(rnaeqmzfqr) = kgdllkuszi kyacrliude (ocnirrvyni, 26) View more	-	21 Mar 2024
NCT05107492 (CTgov)	Phase 1	Inflammatory Bowel Diseases	12	placebo (Placebo)	exndkoopgd = rwenfzwmih ijhefkhzfo (gjyehkuhuq, fdvgtyvuqe - fjftcqegdm) View more	-	21 Mar 2024
NCT04090411 (TUSCANY-2, Corporate Publications) Manual	Phase 2	Colitis, Ulcerative	-	RVT-3101	wrbbqwabfo(zptatqotfw) = pmsybzxnfh hxxdlmnpvo (iechknqhmt ) View more	Positive	22 Jun 2023
NCT02840721 (Phase 2a, FOCIS2020)	Phase 2	Colitis, Ulcerative	45	PF-06480605	yyfvpzwtfs(lxnkuhckup) = mpltvfuofk ggptseygaw (ahhcyckznz )	Positive	28 Oct 2020
NCT02840721 (Phase 2a, CTgov)	Phase 2	Colitis, Ulcerative	50	PF-06480605	fmqfhcfnsk = uxeutiphkr polnakuwaj (emdduyesiy, lmpvqsdsae - bdmcarkrwp) View more	-	19 Jun 2019

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