A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn’s Disease or Ulcerative Colitis - MK-7240-011

Start Date04 Mar 2025

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT06651281

/ RecruitingPhase 3

A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis

Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.

Start Date25 Nov 2024

Sponsor / Collaborator

Merck Sharp & Dohme LLC

CTIS2023-508636-61-00

/ RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease - MK-7240-008

Start Date06 Nov 2024

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

100 Clinical Results associated with Tulisokibart

100 Translational Medicine associated with Tulisokibart

100 Patents (Medical) associated with Tulisokibart

Literatures (Medical) associated with Tulisokibart

01 Mar 2025·Revue medicale de Liege

[Intestinal fibrosis in Crohn's disease : towards new therapeutic options?]

Review

Author: Vieujean, Sophie ; Stepniak, Marty ; Louis, Édouard ; Meuwis, Marie-Alice ; Bequet, Émeline

Crohn's disease is a chronic inflammatory bowel disease that can lead to fibrostenotic complications. These strictures result from an imbalance between inflammation and excessive healing, leading to an abnormal accumulation of extracellular matrix and a progressive thickening of the intestinal wall. To date, no specific treatment is available to prevent or reverse intestinal fibrosis. The management of strictures primarily focuses on controlling inflammation and addressing obstructive complications through endoscopic balloon dilation, stricturoplasty, or intestinal resection. Current medical therapies, such as anti-TNF agents, can help reduce inflammation but have no direct impact on fibrosis. New therapeutic strategies are emerging, including TL1A inhibitors (duvakitug, tulisokibart), an ALK5 inhibitor (AGMB-129), and targeted AGR2 therapies (TH-009). Additionally, mesenchymal stem cells are being investigated in our hospital center in combination with endoscopic balloon dilation, aiming to assess their therapeutic potential. The development of effective anti-fibrotic therapies remains a critical medical need to improve the management of intestinal strictures and reduce the need for invasive procedures in Crohn's disease.

26 Sep 2024·NEW ENGLAND JOURNAL OF MEDICINE

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis

Article

Author: Luo, Allison ; Ritter, Timothy E ; Leszczyszyn, Jaroslaw ; Ma, Christopher ; Feagan, Brian G ; Sands, Bruce E ; Lu, Jiandong ; Yen, Mark ; Targan, Stephan ; Nguyen, Deanna D ; Laurent, Olivier ; McGovern, Dermot P B ; Danese, Silvio ; Peyrin-Biroulet, Laurent ; Kempiński, Radosław ; Rubin, David T

BACKGROUND:

Tulisokibart is a tumor necrosis factor-like cytokine 1A (TL1A) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with an increased likelihood of response.

METHODS:

We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included patients regardless of status with respect to the test for likelihood of response. Cohort 2 included only patients with a positive test for likelihood of response. The primary analysis was performed in cohort 1; the primary end point was clinical remission at week 12. Patients with a positive test for likelihood of response from cohorts 1 and 2 were combined in prespecified analyses.

RESULTS:

In cohort 1, a total of 135 patients underwent randomization. A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26% vs. 1%; difference, 25 percentage points; 95% confidence interval [CI], 14 to 37; P<0.001). In cohort 2, a total of 43 patients underwent randomization. A total of 75 patients with a positive test for likelihood of response underwent randomization across both cohorts. Among patients with a positive test for likelihood of response (cohorts 1 and 2 combined), clinical remission occurred in a higher percentage of patients who received tulisokibart than in those who received placebo (32% vs. 11%; difference, 21 percentage points; 95% CI, 2 to 38; P = 0.02). Among all the enrolled patients, the incidence of adverse events was similar in the tulisokibart and placebo groups; most adverse events were mild to moderate in severity.

CONCLUSIONS:

In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. (Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797.).

01 Jan 2024·Advances in pharmacology (San Diego, Calif.)

TL1A: A model for a precision medicine approach in the treatment of Crohn’s disease and ulcerative colitis

Review

Author: Bilsborough, Janine M ; Targan, Stephan R. ; Targan, Stephan R ; Bilsborough, Janine M.

Inflammatory bowel disease (IBD) is a collective term for chronic inflammatory diseases of the intestinal tract. The term IBD encompasses two main forms, Crohn's disease (CD) and Ulcerative colitis (UC). CD is characterized by inflammation throughout the length of the gut, especially the ileum and colon, and is often complicated with fistulae and/or intestinal strictures. Ulcerative colitis (UC) is inflammatory disease restricted to the colon and rectum. In practice however, IBD is a heterogenous disease with CD and UC representing the extremes of a continuum of diseases with varied clinical presentation, including disease location, severity, and manifestation of extraintestinal diseases. This disease heterogeneity poses a challenge to successful and efficacious therapeutic treatment as the etiology driving disease in individual patients is unknown and likely to be multifactorial, including genetic predisposition, environmental factors such as the microbiota, as well as social behaviors such as smoking and diet. Precision medicine provides a strategy to account for disease heterogeneity and diverse etiology to select for patients most likely to respond to a given therapeutic. In this chapter we present an example of the development of a novel antibody therapeutic, Tulisokibart, as a model for a Precision Medicine approach to the successful treatment of patients with IBD.

News (Medical) associated with Tulisokibart

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

20 Mar 2025

·endpts.com

Updated: Monte Rosa reports first data for molecular glue program licensed to Novartis

Monte Rosa Therapeutics reported Phase 1 data Thursday morning for a Novartis-partnered program that the companies believe could change the treatment paradigm for some immune-mediated diseases. Though the data come from healthy volunteers, observers are keen to see whether the program known as MRT-6160 can affect certain immunological biomarkers while remaining safe. Other drug classes targeting the immune system, particularly JAK and interleukin inhibitors, can sometimes cause taxing side effects for patients. In the Phase 1 study, researchers tested MRT-6160 in 70 individuals across five single-ascending doses and three multiple-ascending doses. The program degraded a protein called VAV1 by greater than 90% in individuals’ peripheral T cells in all but the lowest dose cohorts, according to SEC documents. The results were also dose-dependent. Monte Rosa also measured VAV1 degradation in peripheral B cells, with MRT-6160 inducing “similar” results to the T cell data — although the company did not report specific figures. On an investor call Thursday morning, Monte Rosa executives were asked how the results might translate to patients, given that the Phase 1 came from ex vivo stimulation of healthy volunteers’ blood cells. CEO Markus Warmuth said it would depend on the disease but the company is confident in how MRT-6160 hit its biomarkers. Following the Phase 1 trials, Novartis is expected to take over development and decide which diseases to test Phase 2. Preparation for Phase 2 studies is ongoing. Warmuth said the final decision on which diseases to test MRT-6160 in Phase 2 has not been made, but hinted at where Monte Rosa and Novartis see the most potential. “We had a very strong preclinical data in [ulcerative colitis], very interesting data in rheumatoid arthritis,” Warmuth said. “There’s related diseases you could think about.” MRT-6160 is designed to target VAV1, which works downstream of T cell and B cell receptors, according to Monte Rosa. The idea is to reduce cytokine proteins that fuel autoimmune conditions when modulated. The data also provide an early snapshot into the potential of molecular glues. The space has grown significantly in the last 18 months, with at least 10 licensing deals signed between biotech and pharma partners. Novartis paid Monte Rosa $150 million upfront for full rights to MRT-6160 in the largest upfront payment for a molecular glue deal in that time frame . Jefferies analyst Kelly Shi previewed the data in a Sunday note, saying the expectation heading into Thursday was VAV1 degradation of about 80%, as well as reducing certain biomarker expression by at least 70%. Such a profile, Shi wrote, could “support its early potential” in both rheumatoid arthritis and inflammatory bowel disease. The four main biomarkers Shi highlighted were CD69, IL-2, IL-6, and IL-17, with the latter three implicated in AbbVie’s JAK inhibitor Rinvoq. IL-17 in particular plays an important role in ulcerative colitis. Another experimental drug, Merck and Prometheus’ anti-TL1A program MK-7240, showed a 50% reduction in IL-17 for IBD patients in a Phase 2 study. Results from the trial showed that in CD69, MRT-6160 suppressed regulation by greater than 90% in certain doses, Monte Rosa said. The program also inhibited IL-2, IFN-γ and IL-17A “by up to 99%.” IL-6 levels were between 60% and 90%. Safety data indicated all side effects were mild or moderate. Monte Rosa’s stock price $GLUE was volatile premarket, going up about 6% and then falling as much as 16% Thursday morning. After the market opened, shares were up about 8%. Separately, Monte Rosa released new Phase 2 data for an oncology program called MRT-2359, which it is developing in-house. This molecular glue aims to degrade the GSPT1 protein in the hopes of improving outcomes for cancer patients with tumors driven by what are known as MYC transcription factors. So far, researchers tested the program in 59 patients with MYC-related malignancies. They found that, among 37 evaluable patients, MRT-2359 induced one partial response in a patient with MYC biomarkers. There was also one unconfirmed partial response in an individual who was biomarker negative. Monte Rosa is opting to deprioritize most indications. Warmuth noted on the call that the partial response occurred in a patient with neuroendocrine bladder cancer. The patient had “extremely high expression” of MYC biomarkers. The lead indication for MRT-2359 will now be castration-resistant prostate cancer, and all lung cancer work will be shelved. Monte Rosa will still enroll patients with HR+ breast cancer. Additional data will be available for both prostate and breast cancer in the second half of the year. Monte Rosa does not yet have data from prostate cancer patients, Warmuth said, because it hasn’t received clear biopsies. When the company reports data later this year, Warmuth said he hopes there will be results from 20 to 30 prostate cancer patients. Monte Rosa also reported its full-year and fourth-quarter earnings Thursday morning, saying its cash runway will extend into 2028. Editor’s note: This article was updated to include additional information from Monte Rosa’s investor call on Thursday morning.

Phase 1Clinical ResultPhase 2

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

100 Deals associated with Tulisokibart

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Crohn Disease	Phase 3	United States	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	China	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Japan	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Australia	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Austria	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Belgium	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Canada	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Chile	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Colombia	Merck Sharp & Dohme LLC	05 Jun 2024
Crohn Disease	Phase 3	Croatia	Merck Sharp & Dohme LLC	05 Jun 2024

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Colitis, Ulcerative	-	Tulisokibart 100 mg	wedsnuxmhs(rekifjijwg) = Through week 50, AEs occurred in 63% and 77% of patients receiving tulisokibart 250 mg and 100 mg, respectively; most were mild to moderate in severity. Serious AEs occurred in 1 patient (3%) and two patients (7%) in the tulisokibart 250 mg and 100 mg groups, respectively. wohwzcsbzp (mvloaexpsy )	-	13 Oct 2024
				Tulisokibart 250 mg
NCT04996797 (ARTEMIS-UC, Pubmed \| N Engl J Med) Manual	Phase 2	Colitis, Ulcerative	135	Tulisokibart	inmorulxoe(htbtinxnlb) = rxabxhdhih bcrkjdfdsu (pvxaqkrqgo )	Positive	26 Sep 2024
				Placebo	inmorulxoe(htbtinxnlb) = rucqmksumv bcrkjdfdsu (pvxaqkrqgo )
NCT04996797 (ARTEMIS-UC, CTgov)	Phase 2	Colitis, Ulcerative	178	Tulisokibart (Cohort 1 Tulisokibart)	snubbwrrdi = wwzqpjvvsm wngwoyssbf (wprcwodmvb, tcrnoxtyzr - isivgzjdhc) View more	-	27 Jun 2024
				Placebo (Cohort 1 Placebo)	snubbwrrdi = bpjfecrrjw wngwoyssbf (wprcwodmvb, pgpsylaqqh - fqhvxmrpfc) View more
NCT05013905 (APOLLO-CD, CTgov)	Phase 2	Crohn Disease	55	Companion diagnostic (CDx)+PRA023 IV	fkfkgagiqb = yhjmbcfnku wnhywbljyq (jdaautjewt, oknktjqgio - cgygpvwnsq) View more	-	01 Nov 2023
UEGW2023	Not Applicable	Ulcerative colitis, active moderate	-	PRA023	werbrjwxwl(htpvanrfsp) = xnatagaxsd uzolrfffdx (pfzbihqzhu, 34.85) View more	-	15 Oct 2023
				Placebo	werbrjwxwl(htpvanrfsp) = dmtndxizke uzolrfffdx (pfzbihqzhu, 37.59) View more
NCT04996797 (ARTEMIS-UC, UEGW2023)	Phase 2	Ulcerative colitis, active moderate eosinophils \| neutrophils	135	PRA023	phybzvqgly(kerwkcbpkj) = tfbvcynzni lusriejnft (dimrolapce ) View more	Positive	15 Oct 2023
				Placebo	phybzvqgly(kerwkcbpkj) = ftmoxinafd lusriejnft (dimrolapce ) View more
ARTEMIS-UC \| COHORT 1 (UEGW2023)	Phase 2	Ulcerative colitis, active moderate TL1A	135	PRA023	tvklsmydwd(ousalspsxb) = lazdmyjroh dycftorfpe (mjdogubhqo ) View more	Positive	15 Oct 2023
				Placebo	tvklsmydwd(ousalspsxb) = kwwbtropdx dycftorfpe (mjdogubhqo ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis