Cogent Biosciences Announces Additional Clinical Data from Part 1 of its Ongoing SUMMIT Trial Evaluating Bezuclastinib in Patients with NonAdvanced Systemic Mastocytosis (NonAdvSM)

Core Insights - Cogent Biosciences announced promising data from the SUMMIT clinical trial for bezuclastinib, a selective KIT D816V inhibitor, showing significant reductions in symptoms for patients with nonadvanced systemic mastocytosis [5][16] - The trial demonstrated over 90% reductions in mast cell burden and clinically meaningful improvements in various symptoms, including skin lesions and overall disease severity [6][12][16] Company Overview - Cogent Biosciences is focused on developing precision therapies for genetically defined diseases, with bezuclastinib being the most advanced program targeting systemic mastocytosis and gastrointestinal stromal tumors [4][5] - The company is based in Waltham, MA, and Boulder, CO, and is actively engaged in clinical trials to expand its portfolio of targeted therapies [4] Clinical Trial Details - The SUMMIT trial is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of bezuclastinib in patients with nonadvanced systemic mastocytosis [6][16] - As of December 18, 2023, the recommended dose of 100 mg showed a favorable safety profile, with no serious adverse events reported [13][16] - Enrollment for the registration-directed SUMMIT Part 2 study is expected to be completed in the second quarter of 2025, with topline results anticipated by year-end 2025 [14][16]