Cogent Biosciences (NASDAQ: COGT) has announced positive topline results from the SUMMIT trial of bezuclastinib in patients with non-advanced systemic mastocytosis (NonAdvSM), achieving statistical significance across all primary and secondary endpoints.
According to Cogent, based on these results, the company is on track to submit its first new drug application (NDA) to the FDA for bezuclastinib in NonAdvSM by the end of 2025. Additionally, Cogent plans to present detailed results from the SUMMIT trial at an upcoming medical meeting later this year.
In a statement, Andrew Robbins, CEO of Cogent, commented, “We have been eagerly awaiting this day and are thrilled to announce bezuclastinib’s performance in the SUMMIT trial, demonstrating clinically meaningful and statistically significant results across all trial endpoints. Our team is already at work on our first NDA for bezuclastinib that we expect to file with the FDA later this year. We are committed to providing bezuclastinib access to the thousands of patients with NonADvSM as quickly as possible, including through our recently announced Bezuclastinib Expanded Access Program.”
Nathan Boggs, MD, PhD, allergy division director of Uniformed Services University, Walter Reed National Military Medical Center, added, “People living with NonAdvSM experience debilitating symptoms with enormous impact on their physical and psychological quality of life. It is extremely encouraging to see the results of the SUMMIT trial, which match my own experience treating patients with bezuclastinib, as these results suggest there will soon be a new standard of care available for this patient population with significant unmet medical need.”
