Cogent Biosciences, Inc. (NASDAQ: COGT) shares fell first thing Friday, as the biotechnology company, focused on developing precision therapies for genetically defined diseases announced additional data from Part 1 of its ongoing SUMMIT clinical trial evaluating the selective KIT D816V inhibitor, bezuclastinib, in patients with nonadvanced systemic mastocytosis (NonAdvSM). The data are being presented today in a poster presentation at the 2024 European Hematology Association (EHA) Congress taking place in Madrid, Spain.
“We are excited to share additional analyses from SUMMIT Part 1 which highlight substantial symptomatic reductions as well as improvement in objective measures of disease,” said CEO Andrew Robbins. “We remain 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. In addition, the study was designed to explore 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 (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.
COGT shares gave up 13 cents, or 1.5% to $8.85.
