Cogent: Bezuclastinib's SUMMIT Trial In NonAdvSM Shows Substantial Reduction In Most Severe Symptoms

(RTTNews) - Cogent Biosciences, Inc. (COGT), a biotechnology company focused on precision therapies for genetically defined diseases, announced Friday additional data from Part 1 of its ongoing SUMMIT clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with nonadvanced systemic mastocytosis or NonAdvSM.

The company noted that patients treated with 100 mg bezuclastinib showed substantial reduction in their most severe symptoms and mast cell reactions in NonAdvSM, a debilitating hematologic disorder.

Cogent said it remains on track to complete enrollment in the registration-directed SUMMIT Part 2 study in the second quarter of 2025 and report topline results by year-end 2025.

SUMMIT is a randomized, double-blind, placebo-controlled, global, multicenter, Phase 2 clinical trial of bezuclastinib in patients with NonAdvSM. Part 1 of the trial was designed to determine the recommended dose of bezuclastinib.

The study also explores the effects of bezuclastinib on the signs and symptoms of NonAdvSM, including assessment of disease-specific symptom severity using a novel patient-reported outcome measure, the Mastocytosis Symptom Severity Daily Diary or MS2D2.

As of the cutoff date, December 18, 2023, patients in Part 1 treated at the recommended dose of 100 mg bezuclastinib demonstrated >90% reductions across all markers of mast cell burden.

The company said the additional data also show meaningful reduction in symptom severity and objective measures of disease.

The company is presenting the data today in a poster presentation at the 2024 European Hematology Association (EHA) Congress in Madrid, Spain.

Cogent further said it remains on track to complete enrollment in the APEX study in patients with advanced systemic mastocytosis or AdvSM by the end of 2024 and report top-line results mid-2025.

Enrollment continues in the Phase 3 registration-enabling PEAK study, which will include approximately 388 second-line, post imatinib patients with Gastrointestinal Stromal Tumors or GIST. The company expects PEAK enrollment to be completed in the third quarter of 2024 with top-line results expected by the end of 2025.

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