BCD-261 / Biocad - LARVOL DELTA

Targeting the TL1A pathway in inflammatory bowel disease: mechanistic insights and emerging therapeutic pipeline. (PubMed, Inflamm Bowel Dis) - "Three anti-TL1A monoclonal antibodies (tulisokibart, afimkibart, and duvakitug) have advanced to phase 3 trials across multiple global programs, with phase 2 clinical remission rates of 26%-48% in ulcerative colitis (placebo-adjusted differences 15-26 percentage points) and endoscopic response rates of 26%-48% in Crohn's disease, alongside favorable safety profiles...The pipeline has expanded to at least 19 development programs, including extended half-life antibodies (XmAb942, SPY002, and BCD-261), bispecifics combining TL1A with IL-23 or α4β7 (RO7837195, XmAb412, LQ080, and ALX001), a first-in-class oral anti-TL1A nanobody, and a first-in-class DR3 receptor antagonist (SL-325). We discuss therapeutic positioning and timing, the opportunity in acute severe UC, and the unusual standing of IBD as the lead indication for this mechanism class."

Journal • Review • Crohn's disease • Fibrosis • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Oncology • Ulcerative Colitis • CD40LG • IL23A • TNFA • TNFRSF25 • TNFSF15

Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: SPH-BIOCAD (HK) Limited | Not yet recruiting ➔ Active, not recruiting

Enrollment closed

Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: SPH-BIOCAD (HK) Limited

New P1 trial

Another drug for Crohn’s disease treatment is being developed in Russia (GxP News) - "'A molecule discovered earlier and enzymes synthesized based on it through biotechnological means have shown potential effectiveness in several areas.'...According to Tekutyeva, preclinical trials of the enzyme-based drug are now underway...According to the company’s website, patients are currently being recruited for Phase II...Eligible patients are those 18-75 for whom prior therapies—glucocorticoids, immunosuppressants, or biologics—have proven ineffective. The study will take place in 33 hospitals across 17 Russian cities."

Preclinical • Trial status • Crohn's disease

ULTRAMARINE: A Randomized Double-Blind, Placebo-Controlled Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - P2 | N=198 | Recruiting | Sponsor: Biocad

New P2 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

COMANDOR: Clinical Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Crohn's Disease (clinicaltrials.gov) - P2 | N=204 | Recruiting | Sponsor: Biocad

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease