Cogent Biosciences (NASDAQ: COGT) saw a significant stock price increase on Monday following the release of encouraging clinical trial data for bezuclastinib, a treatment for non-advanced systemic mastocytosis (SM). This rare disease is characterized by the accumulation of mast cells in body tissues and organs. The updated results, presented at the American Society of Hematology Annual Meeting & Exposition, showcased significant improvements in symptom severity and quality of life for patients.
Table Content:
- Bezuclastinib Demonstrates Strong Efficacy in Reducing Symptoms and Improving Quality of Life
- Pharmacodynamic Data Highlights Bezuclastinib’s Impact on Serum Tryptase Levels
- Favorable Safety Profile Reinforces Bezuclastinib’s Potential
- SUMMIT Part 2 Trial Completion Sets Stage for Potential Regulatory Submission
- Conclusion: Positive Clinical Data Drives Cogent Biosciences Stock Higher
Bezuclastinib Demonstrates Strong Efficacy in Reducing Symptoms and Improving Quality of Life
The updated data from the Open Label Extension (OLE) portion of the SUMMIT trial revealed compelling evidence of bezuclastinib’s effectiveness. Key findings include:
- Significant Symptom Reduction: Patients experienced a mean improvement of 56% in Total Symptom Score (TSS) at 24 weeks. Furthermore, 76% of patients achieved a greater than 50% reduction from their baseline TSS, with 88% surpassing a 30% reduction.
- Enhanced Quality of Life: Bezuclastinib treatment led to a 49% mean improvement in quality of life Total Score at the 24-week mark.
- Reduced Reliance on Supportive Care: Impressively, 31% of patients were able to reduce or discontinue best supportive care (BSC) medications after 24 weeks of treatment.
Pharmacodynamic Data Highlights Bezuclastinib’s Impact on Serum Tryptase Levels
Beyond symptom improvement, bezuclastinib demonstrated a profound impact on serum tryptase, a key biomarker in SM. The data indicated:
- Rapid and Substantial Reduction: 89% of patients experienced a greater than 50% decrease in serum tryptase levels within just four weeks of initiating treatment.
- Sustained Control of Tryptase Levels: By week 24, 95% of patients with baseline tryptase levels ≥20ng/mL achieved levels below 20ng/mL. Similarly, 84% of patients with baseline serum tryptase >11.4ng/ml saw their levels drop below this threshold.
Favorable Safety Profile Reinforces Bezuclastinib’s Potential
The safety data from the trial further bolstered confidence in bezuclastinib. With a median treatment duration of 56 weeks for active arm patients and 40 weeks for placebo crossover patients, the majority of treatment-emergent adverse events were mild and reversible. Importantly, no treatment-related bleeding or cognitive impairment was observed.
SUMMIT Part 2 Trial Completion Sets Stage for Potential Regulatory Submission
Cogent Biosciences also announced the completion of enrollment in the pivotal SUMMIT Part 2 study, with 179 patients participating. Top-line results from this registration-directed trial are anticipated in July 2025, potentially paving the way for regulatory submission and approval.
Conclusion: Positive Clinical Data Drives Cogent Biosciences Stock Higher
The positive clinical data presented for bezuclastinib underscore its potential as a transformative treatment for non-advanced systemic mastocytosis. The significant improvements in symptoms, quality of life, and serum tryptase levels, coupled with a favorable safety profile, have generated considerable excitement among investors, driving COGT stock up over 10% to $9.83. The upcoming results from the SUMMIT Part 2 trial in 2025 will be crucial in determining the future trajectory of bezuclastinib and Cogent Biosciences.
