INSMED's Brensocatib Phase 2b CEDAR Study Misses Primary Endpoint in HS, Placebo Shows Superior 57.1% AN Count Reduction
INSMED Incorporated announced topline efficacy and safety results from its Phase 2b CEDAR study evaluating brensocatib in patients with moderate to severe hidradenitis suppurativa (HS). The study failed to meet its primary endpoint, as both brensocatib treatment arms demonstrated a lesser reduction in abscess and inflammatory nodule (AN) count compared to the placebo arm at Week 16. Specifically, the brensocatib 10 mg and 40 mg arms achieved 45.5% and 40.3% reductions in AN count, respectively, while the placebo arm showed a more significant 57.1% reduction. This outcome represents a significant setback for brensocatib's development in HS, potentially impacting the drug's future in this indication and the company's pipeline valuation.
Key Highlights
- The Phase 2b CEDAR study of brensocatib for hidradenitis suppurativa (HS) enrolled 214 patients across 72 global sites.
- The primary endpoint was the percent change from baseline in total abscess and inflammatory nodule (AN) count at Week 16.
- At Week 16, the brensocatib 10 mg arm showed a 45.5% reduction from baseline in AN count.
- The brensocatib 40 mg arm showed a 40.3% reduction from baseline in AN count.
- The placebo arm demonstrated a superior 57.1% reduction from baseline in AN count, indicating the drug did not meet its primary efficacy endpoint.
- The study was a randomized, double-blind, placebo-controlled trial with participants receiving brensocatib 10 mg, 40 mg, or placebo once daily for 16 weeks.