Cogent Biosciences’ Phase 2 Study on Bezuclastinib: A Potential Game-Changer for Advanced Systemic Mastocytosis

Cogent Biosciences, Inc. ((COGT)) announced an update on their ongoing clinical study.

Cogent Biosciences, Inc. is conducting a Phase 2 clinical study titled ‘A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis.’ The study aims to evaluate the safety and efficacy of CGT9486, also known as bezuclastinib, in treating patients with Advanced Systemic Mastocytosis (AdvSM), including subtypes like Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL). This research is significant as it targets a rare and challenging condition.

The intervention being tested is bezuclastinib, an experimental drug administered orally in tablet form. It is designed to be taken continuously in 28-day cycles, aiming to improve patient outcomes in AdvSM.

This open-label study follows a single-group intervention model with no masking, focusing on treatment as its primary purpose. It consists of two parts: Part I for dose optimization and Part II for expansion, which is further divided into two stages.

The study began on July 22, 2021, and is currently recruiting participants. The primary completion and estimated study completion dates have not been specified, but the last update was submitted on May 29, 2025. These timelines are crucial for tracking the study’s progress and potential results.

The update on this study could influence Cogent Biosciences’ stock performance positively, as advancements in treating rare diseases often boost investor confidence. The competitive landscape in the biotech industry, particularly in rare disease treatment, may also see shifts based on the study’s outcomes.

The study is ongoing, with further details available on the ClinicalTrials portal.