Cogent Biosciences Advances Bezuclastinib Trials for Systemic Mastocytosis

Cogent Biosciences Updates on Bezuclastinib Trials for Systemic Mastocytosis

Cogent Biosciences has announced updates on its ongoing clinical trials involving bezuclastinib, a selective tyrosine kinase inhibitor targeting the KIT D816V mutation. This mutation is a primary driver of systemic mastocytosis, a disease characterized by the overproduction of mast cells.

Clinical Trials Progress

The company is currently enrolling patients for APEX Part 2, with completion expected in the first quarter of 2025. Top-line results from this trial are anticipated by mid-2025. Additionally, Cogent will present 24-week follow-up data from the Open Label Extension of the SUMMIT trial at the American Society of Hematology (ASH) conference on December 9, 2024. The SUMMIT trial is a Phase 2 study evaluating bezuclastinib in patients with Nonadvanced Systemic Mastocytosis (NonAdvSM).

Webcast and Presentation Details

Cogent will host a webcast on December 9, 2024, at 8:00 a.m. ET to discuss the clinical results from the APEX and SUMMIT trials. The webcast will be accessible on the Investors & Media page of Cogent's website, with a replay available for 30 days post-event. ASH conference attendees can also view related posters on Cogent’s website.

About Cogent Biosciences

Cogent Biosciences is a biotechnology firm dedicated to developing precision therapies for genetically defined diseases. Their lead product, bezuclastinib, is designed to inhibit mutations in KIT exon 17, which are implicated in systemic mastocytosis and gastrointestinal stromal tumors. The company is also working on therapies targeting FGFR2, ErbB2, PI3Kα, and KRAS mutations.

Forward-Looking Statements

This announcement includes forward-looking statements regarding the anticipated completion of clinical trial enrollment and the potential impact of bezuclastinib on treatment landscapes. These statements are based on current expectations and are subject to risks and uncertainties.