Insmed has announced a setback in its efforts to tackle hidradenitis suppurativa (HS), a chronic skin condition, as the Phase 2b CEDAR study of brensocatib failed to meet primary or secondary efficacy endpoints. 

 

The results were consistent across both the 10 mg and 40 mg treatment arms.

 

“The CEDAR study was designed as a proof-of-concept study to determine whether brensocatib could provide benefit for patients with HS—a disease where the lack of established animal models makes clinical development particularly challenging,” said Martina Flammer, Chief Medical Officer of Insmed. 

 

“While we are disappointed in the results, we hope that insights gained from this study will contribute to the broader scientific understanding of HS. We are grateful to the patients and investigators who participated in this study.”

 

Despite the lack of efficacy, brensocatib was well tolerated, and no new safety signals were identified, even at the 40 mg dose, the highest Insmed has studied to date.

 

At Week 16, participants showed a 45.5% and 40.3% reduction from baseline in total abscess and inflammatory nodule (AN) count in the 10 mg and 40 mg arms, respectively—trailing the 57.1% reduction observed in the placebo group.

 

Insmed said it will discontinue development of brensocatib for HS but plans to present the study data at a future scientific congress.