Insmed Incorporated reported that the Phase 2b CEDAR study evaluating brensocatib in adults with moderate to severe hidradenitis suppurativa (HS) did not meet its primary or secondary efficacy endpoints. Based on these results, Insmed will discontinue development of brensocatib for HS.
The randomized, double-blind, placebo-controlled trial enrolled 214 patients across 72 sites to assess two oral doses of brensocatib—10 mg and 40 mg—over 16 weeks. The primary endpoint measured percent change from baseline in total abscess and inflammatory nodule (AN) count at Week 16. Patients in the 10 mg and 40 mg arms demonstrated AN count reductions of 45.5% and 40.3%, respectively, compared with a 57.1% reduction in the placebo group.
Despite the lack of efficacy, brensocatib was well tolerated at both dose levels, including the 40 mg dose, the highest tested to date. No new safety signals were identified. Treatment-emergent adverse events occurred in 55.4%, 42.9%, and 45.7% of patients receiving brensocatib 10 mg, brensocatib 40 mg, and placebo, respectively.
Insmed stated that while the proof-of-concept study did not demonstrate clinical benefit, data from the trial may help inform future HS research. The company plans to present the full study findings at an upcoming scientific congress.
Brensocatib, a DPP1 inhibitor, continues to be evaluated in other inflammatory disease indications.
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