Merck's TL1A Inhibitor MK-7240, Acquired for $10.8 Billion, Receives Chinese Clinical Approval for Moderate to Severe Ulcerative Colitis

Feb 22, 2024 16:46 CST Updated 16:46

MSD

Pharmaceutical R&D and Manufacturer

▎Edited by the WuXi AppTec content team

The official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that MK-7240, submitted by MSD, has obtained tacit approval for clinical trials and is proposed for development to treatModerate to Severe Active Ulcerative Colitis. Public information shows that this is aHumanized monoclonal antibody (mAb) targeting tumor necrosis factor (TNF)-like ligand 1A (TL1A)In June 2023, Merck & Co., Inc. (MSD) completed the acquisition of Prometheus Biosciences for a total amount of $10.8 billion.Acquisition, thereby obtaining this product in the immunology field.

Screenshot source:CDE Official Website

TL1A is a target associated with enteritis and fibrosis. It exhibits physiological activities such as T cell activation and promotion of inflammatory cytokine secretion, playing a crucial role in immune regulation and inflammatory diseases. Drugs targeting TL1A have the potential to treat immune-mediated diseases, including ulcerative colitis, Crohn's disease, and other autoimmune conditions.

MK-7240（tulisokibart，The original R&D code name, PRA023, is indeed aTL1A Inhibitor,ItCan specifically bind to soluble or cell membrane-bound TL1A, significantly altering those with elevated TL1A expression levels.Inflammatory Bowel Disease (IBD)The Potential of the Patient's ConditionUlcerative colitis and Crohn's disease both belong to IBD. Due to intestinal inflammation, patients experience symptoms such as abdominal pain, bloody stools, and diarrhea, significantly impacting their quality of life.

▲MK-7240Mechanisms Mediating Inflammation and Fibrosis (Image Source: Reference [3])）

In June 2023, MSD announced the completion of its acquisition of Prometheus Biosciences, thereby acquiring new ulcerative colitis, Crohn's disease, and other autoimmune disease drug candidates to enhance its immunology portfolio, including the MK-7240.

Earlier,MK-7240 has alreadyPositive results were achieved in the clinical studies named ARTEMIS-UC and APOLLO-CD, with the former targeting moderate to severeUlcerative ColitisA Phase 2, placebo-controlled study in patients, the latter being a Phase 2a open-label study in patients with moderate to severe Crohn's disease. Among them,Phase 2 Randomized Double-Blind Clinical Trial for Moderate to Severe Ulcerative Colitis Meets Primary Endpoint.After 12 weeks of treatment,MK-724026.5% of patients in the treatment group reached the primary endpoint of clinical remission, compared to 1.5% in the control group;MK-7240 Group36.8% of patients in China reached the secondary endpoint of endoscopic improvement, compared to 6.0% in the placebo group. This research data was previously released in 2023.Presented at the European Crohn's and Colitis Organisation (ECCO) Congress.

According toClinicalTrialsAccording to the official website, MSD has now been launched in the United States.Phase 3 Clinical Study of MK-7240, Evaluating the Product for TreatmentModerate to Severe Active Ulcerative Colitisefficacy and safety. The approval of this product for clinical trials in China means that it will also conduct clinical research in China.

TL1A blockers have now become a potential new therapy for treating inflammatory and fibrotic diseases. Public information shows that several large pharmaceutical companies are developing this target, such asRocheThe TL1A antibody RVT-3101, which is under development, is about to initiate Phase 3 clinical trials.SanofiAnnounced in October 2023 a deal worth up to approximately $1 billion with Teva PharmaceuticalsAgreement, thereby developing the latter's TL1A-targeted therapy TEV’574;PfizerTLA1 inhibitor PF-06480605 has also previously achieved positive results in a Phase 2 clinical study for the treatment of ulcerative colitis.

References:

[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Feb 22, 2024, from https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d

[2] Merck Completes Acquisition of Prometheus Biosciences, Inc. Retrieved June 19, 2023 from https://www.merck.com/news/merck-completes-acquisition-of-prometheus-biosciences-inc/

[3] Acquisition of Prometheus Biosciences. Retrieved April 17, 2023, from https://s21.q4cdn.com/488056881/files/doc_presentations/2023/04/Splash-Investor-Event-Slides-FINAL-1.pdf

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