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A Phase 3 registrational trial in patients with Primary Sclerosing Cholangitis

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Trial Profile

A Phase 3 registrational trial in patients with Primary Sclerosing Cholangitis

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 07 Mar 2025

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At a glance

  • Drugs CM 101 (Primary)
  • Indications Primary sclerosing cholangitis
  • Focus Registrational; Therapeutic Use
  • Sponsors Chemomab Therapeutics

    • Most Recent Events

    • 03 Mar 2025 According to a Chemomab Therapeutics media release, 20mg/kg dose of nebokitug has been selected for the active treatment arm of the Phase 3 trial.
    • 19 Feb 2025 According to a Chemomab Therapeutics media release, company announced the successful completion of its End-of-Phase 2 Meeting with the U.S. Food and Drug Administration (FDA) and alignment with FDA on the design of a single Phase 3 registration study for its lead product candidate nebokitug (CM-101) for the treatment of primary sclerosing cholangitis (PSC).
    • 25 Jul 2024 According to a Chemomab Therapeutics media release, company is preparing for an End-of-Phase 2 meeting with the FDA to discuss the SPRING trial results and the design of a proposed Phase 3 PSC trial for accelerated approval. The company anticipates completing these discussions by the end of the year and receiving official written feedback from the FDA in the first quarter of 2025.

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