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 - Bezuclastinib demonstrates substantial efficacy in reducing severe symptoms and mast cell reactions in patients with nonadvanced systemic mastocytosis, addressing significant unmet medical needs [1][4][9] - The ongoing SUMMIT clinical trial is focused on evaluating bezuclastinib's effectiveness and safety, with promising results presented at the 2024 European Hematology Association Congress [2][10] Clinical Trial Details - The SUMMIT trial is a randomized, double-blind, placebo-controlled Phase 2 clinical trial designed to assess the recommended dose of bezuclastinib and its effects on symptoms of nonadvanced systemic mastocytosis [10] - As of December 18, 2023, patients treated with the recommended dose of 100 mg showed over 90% reductions in markers of mast cell burden and clinically meaningful improvements in symptom severity [10][4] Safety and Tolerability - The 100 mg dose of bezuclastinib has a favorable safety and tolerability profile, with no reported serious adverse events or cognitive impairment [4][11] - The trial results indicate significant reductions in individual symptoms measured by the Mastocytosis Symptom Severity Daily Diary (MS2D2) [4][9] Future Developments - Cogent Biosciences is on track to complete enrollment in the registration-directed SUMMIT Part 2 study by the second quarter of 2025, with topline results expected by the end of 2025 [9][11] - The company is also progressing with the APEX study for advanced systemic mastocytosis, aiming for completion by the end of 2024 [11]