tulisokibart (MK-7240) / Merck (MSD) - LARVOL DELTA

Efficacy and safety results of tulisokibart re-induction treatment in participants with ulcerative colitis in the Phase 2 ARTEMIS-UC clinical trial (ECCO-IBD 2025) - No abstract available

Clinical • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

ATHENA-SSc-ILD: Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007) (clinicaltrials.gov) - P2 | N=152 | Recruiting | Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Trial completion date: Dec 2028 ➔ Jun 2029 | Trial primary completion date: Dec 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Immunology • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Scleroderma • Systemic Sclerosis

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) (clinicaltrials.gov) - P3 | N=1349 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Merck Sharp & Dohme LLC | Recruiting ➔ Active, not recruiting

Enrollment closed

TL1A: A model for a precision medicine approach in the treatment of Crohn's disease and ulcerative colitis. (PubMed, Adv Pharmacol) - "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."

Journal • Review • Colorectal Cancer • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Ulcerative Colitis (UC): Results From the Open-Label Extension (OLE) Period of the Phase 2 ARTEMIS-UC Study (ACG 2024) - "47 cohort 1 induction responders in the tulisokibart group were randomized to receive tulisokibart 250 mg (n=25) or 100 mg (n=22). Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups (Table). A greater proportion of patients achieved clinical and endoscopic outcomes with tulisokibart 250 vs 100 mg."

Clinical • P2 data • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

Long-Term Efficacy and Safety of Intravenous (IV) Tulisokibart in Patients With Crohn's Disease (CD): Results from the Open-Label Extension Period of the Phase 2 APOLLO-CD Study (ACG 2024) - "53 of 55 participants completed the 12-week induction period; 37 were considered induction responders and were randomized to receive tulisokibart 250 mg (n=18) or 100 mg (n=19). A greater proportion of participants who were biologic-naive entered the OLE in the tulisokibart 250 vs 100 mg group (44% vs 21%). Improvements in clinical, endoscopic, and biomarker outcomes observed with tulisokibart were generally maintained through week 50 in both dose groups."

Clinical • P2 data • Crohn's disease • Fibrosis • Gastroenterology • Immunology • Inflammatory Bowel Disease • Oncology • CRP • TNFA

CHARACTERIZATION OF TWO NOVEL EXTENDED HALF-LIFE MONOCLONAL ANTIBODY DRUG CANDIDATES TARGETING TL1A FOR THE TREATMENT OF IBD (UEGW 2024) - "Aims & SPY002-091 and SPY002-072 were evaluated in multiple in vitro and ex vivo assays and compared to other anti-TL1A mAbs in clinical development (MK-7240, RG6631, and TEV-48574). We have characterized two anti-TL1A antibodies that exhibit high selectivity and affinity for TL1A, demonstrate effective blockade of the TL1A interaction with DR3, and potently inhibit downstream cellular signaling. With an extended half-life observed in NHP, both SPY002-091 and SPY002-072 demonstrate therapeutic potential for effective and safe treatment of CD and UC with the advantage of infrequent SC dosing. Further preclinical and clinical studies are warranted to demonstrate this potential."

Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • FASLG • TNFA

LONG-TERM EFFICACY AND SAFETY OF TULISOKIBART IN PATIENTS WITH CROHN’S DISEASE (CD): RESULTS FROM THE OPEN-LABEL EXTENSION PERIOD OF THE PHASE 2 APOLLO-CD STUDY (UEGW 2024) - "At week 50, maintenance of treatment efficacy was generally observed in 12-week induction responders. A trend for higher maintenance efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no safety signals identified through 50 weeks of treatment."

Clinical • P2 data • Crohn's disease • Fibrosis • Gastroenterology • Immunology • Infectious Disease • Inflammatory Bowel Disease • Influenza • Nephrology • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • CRP • TNFA

Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) (clinicaltrials.gov) - P3 | N=1349 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

LONG-TERM EFFICACY AND SAFETY OF TULISOKIBART IN PATIENTS WITH ULCERATIVE COLITIS (UC): RESULTS FROM THE OPEN-LABEL EXTENSION PERIOD OF THE PHASE 2 ARTEMIS-UC STUDY (UEGW 2024) - "At week 50, maintenance of treatment effect was generally observed in cohort 1 induction responders in the tulisokibart group. A trend for higher efficacy with tulisokibart 250 mg vs 100 mg maintenance treatment was observed at week 50. Tulisokibart was well tolerated with no identified safety signals."

Clinical • P2 data • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CRP • TNFA

DISCOVERY AND CHARACTERIZATION OF A NOVEL HIGH-AFFINITY ANTI-TL1A MONOCLONAL ANTIBODY WITH EXTENDED HALF-LIFE FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASE (UEGW 2024) - "Select clinical candidate antibodies were further compared to clinical-stage anti-TL1A mAbs PRA023/MK-7240/tulisokibart, RVT-3101/RG6631, and TEV-48574. The clinical candidate antibodies bind with high affinity and specificity to TL1A and demonstrate potent blockade of TL1A-mediated DR3 receptor signaling. In human FcRn knock-in mice and in cynomolgus monkeys, these antibodies show an extended half-life consistent with FDA-approved antibodies using the XtendTM technology. These data demonstrate the therapeutic potential of the clinical candidate antibodies in the treatment of TL1A-mediated diseases such as ulcerative colitis and Crohn’s disease - with the advantage of infrequent subcutaneous dosing."

Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CD4 • FASLG • IFNG • TNFA • TNFRSF25

Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Merck to Present New Long-Term Data for Tulisokibart (MK-7240), an Investigational Anti-TL1A Monoclonal Antibody, in Inflammatory Bowel Disease at UEG Week 2024 (Merck (MSD) Press Release) - "Merck...today announced that new data highlighting the long-term efficacy and safety of tulisokibart (MK-7240), an investigational humanized monoclonal antibody directed to a novel target, tumor necrosis factor (TNF)-like cytokine 1A (TL1A), in ulcerative colitis (UC) and Crohn’s disease (CD) will be presented at the United European Gastroenterology (UEG) Week 2024 Congress in Vienna, Austria. Long-term efficacy and safety data for tulisokibart from the open-label extension period of the Phase 2 ARTEMIS-UC and APOLLO-CD studies will be featured in two oral presentations...Merck has initiated two Phase 3 studies to evaluate the efficacy and safety of tulisokibart in patients with UC (ATLAS-UC; NCT06052059) and CD (ARES-CD; NCT06430801). These are the first Phase 3 clinical studies for an anti-TL1A antibody in inflammatory bowel disease."

P2 data • P2a data • Trial status • Crohn's disease • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis. (PubMed, N Engl J Med) - P2 | "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.)."

Clinical • Journal • P2 data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010) (clinicaltrials.gov) - P1 | N=60 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 ➔ Oct 2032

Trial completion date • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) (clinicaltrials.gov) - P3 | N=1200 | Recruiting | Sponsor: Merck Sharp & Dohme LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

EARLY CHANGE IN CDAI PREDICTS IMPROVED QUALITY OF LIFE AFTER 12-WEEK INDUCTION THERAPY WITH TULISOKIBART IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE: A POST HOC ANALYSIS FROM APOLLO-CD (DDW 2024) - "Treatment with tulisokibart led to early improvements in health-related QoL in patients with moderately to severely active Crohn's disease. Early changes in disease activity correlated with week 1 QoL improvement."

Clinical • HEOR • Retrospective data • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • CRP • TNFA

RELATIONSHIP BETWEEN SYMPTOM RESOLUTION AND CLINICAL RESPONSES AFTER 12 WEEKS OF TREATMENT WITH TULISOKIBART IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS: A POST HOC ANALYSIS FROM ARTEMIS-UC (DDW 2024) - "In patients with moderately to severely active UC tulisokibart led to rapid symptom improvement. BU resolution was associated with clinical remission clinical response and endoscopic improvement. Of the PROs improvement in SF was the strongest predictive measure for clinical remission at week 1 ."

Clinical • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • TNFA

A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008) (clinicaltrials.gov) - P3 | N=1200 | Not yet recruiting | Sponsor: Merck Sharp & Dohme LLC

New P3 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis. (PubMed, Med) - "Investigational drug TEV-48574, potentially exerting dual antifibrotic and anti-inflammatory effects, is undergoing a phase 2 basket study in both ulcerative colitis (UC) and Crohn disease (CD). Results are eagerly awaited, marking advancements in IBD therapeutics. This critical review comprehensively examines the existing literature, illuminating TL1A and the intricate role of DR3 in IBD, emphasizing the evolving therapeutic landscape and ongoing clinical trials, with potential implications for more effective IBD management."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Development and Characterization of SPY002, a Novel Extended Half-life Monoclonal Antibody Drug Candidate Targeting TL1A for the Treatment of IBD (ECCO-IBD 2024) - "Methods SPY002 was evaluated in multiple in vitro and ex vivo assays compared to other clinical anti-TL1A mAbs (PRA023/MK-7240, RVT-3101, and TEV-48574). With an extended half-life in NHP, SPY002 demonstrates therapeutic potential for effective and safe treatment of CD and UC with the advantage of infrequent SC dosing. Further preclinical and clinical studies are warranted to demonstrate this potential."

Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis • FASLG • IFNG • TNFA

Merck’s US$10.8 billion acquisition of the company, TL1A inhibitor approved for clinical use in China [Google translation] (163.com) - "The official website of the Center for Drug Evaluation (CDE) of the China State Food and Drug Administration announced that MK-7240 applied by Merck & Co. (MSD) has received implicit approval for clinical trials and is planned to be developed to treat moderately to severely active ulcerative colitis."

New trial • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

APOLLO-CD: A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Phase classification: P2a ➔ P2

Phase classification • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease • TNFA