- Cogent Biosciences (COGT, Financial) reveals positive SUMMIT trial results for bezuclastinib, achieving statistical significance across all endpoints.
- 87.4% of patients saw a ≥50% reduction in serum tryptase compared to 0% with placebo.
- Strong financial position with $237M in cash and access to a $350M debt facility.
Cogent Biosciences, Inc. (COGT), a biotechnology company, has announced significant findings from its SUMMIT trial of bezuclastinib for non-advanced systemic mastocytosis (NonAdvSM). The trial achieved all primary and key secondary endpoints with a superior mean change in total symptom score of -24.3 points compared to -15.4 points for placebo, marking a placebo-adjusted difference of -8.91 points (p=0.0002).
Among the standout results, 87.4% of patients treated with bezuclastinib achieved a ≥50% reduction in serum tryptase levels compared to none in the placebo group. The favorable safety profile was underscored by mostly low-grade adverse events, which included hair color changes in 69.5% of patients and altered taste in 23.7%.
Cogent plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) by the end of 2025. This is supported by a robust financial backdrop, with the company reporting $237 million in cash and access to an additional $350 million through a debt facility with SLR Capital Partners.
Looking ahead, Cogent is preparing to release additional trial results from the PEAK trial in gastrointestinal stromal tumors (GIST) and the APEX trial in advanced systemic mastocytosis (AdvSM) in the second half of 2025. The company remains committed to offering new therapeutic options for patients with significant unmet needs.
