#USA #Bridgewater #Insmed #brensocatib #Hidradenitis Suppurativa

Insmed Provides Update on Phase 2b CEDAR Study Results

On April 7, 2026, Insmed Incorporated (Nasdaq: INSM) announced crucial developments regarding its Phase 2b CEDAR study, which aimed to evaluate the therapeutic potential of brensocatib in adults suffering from moderate to severe hidradenitis suppurativa (HS). Despite high hopes, the results revealed that the study did not achieve its primary or secondary efficacy endpoints in either the 10 mg or 40 mg dosing groups.

Brensocatib, developed as a potential treatment, was found to be well tolerated by participants, showing no new safety signals even at the highest dose investigated. In light of these findings, Insmed has decided to halt the development program for brensocatib targeting HS and plans to present detailed results at an upcoming congress.

Dr. Martina Flammer, Chief Medical Officer at Insmed, expressed her disappointment regarding the study outcomes but emphasized the importance of the insights gained, noting that the CEDAR study served as a proof-of-concept. Given that HS lacks established animal models, the clinical development process has posed significant challenges. The company remains grateful for the patients and investigators who participated in the trial, and hopes the lessons learned will contribute to a broader understanding of the disease.

In terms of results, by Week 16, the participants on brensocatib showed reductions in total abscess and inflammatory nodule counts of 45.5% in the 10 mg arm and 40.3% in the 40 mg arm, whereas the placebo group experienced a 57.1% reduction. Furthermore, treatment-emergent adverse events during the 16-week placebo-controlled treatment period were documented, revealing a mix of experiences among participants, ranging from mild to severe events.

Details of the Phase 2b CEDAR Study

The CEDAR study involved 214 patients across 72 sites globally and employed a randomized, double-blind, placebo-controlled design. Participants were assigned to one of three treatment groups: brensocatib at a dose of 10 mg, brensocatib at 40 mg, or a placebo, all administered once daily for a period of 16 weeks. Following this initial phase, individuals who completed the first 16 weeks either continued with the randomized dosage of brensocatib or, if they were on placebo, were switched to either 10 mg or 40 mg doses.

The study's primary endpoint focused on the percentage change from baseline in total abscess and inflammatory nodule counts at Week 16, which ultimately did not meet the predefined efficacy thresholds.

About Insmed and Future Aspirations

Insmed Incorporated is known for placing people at the forefront of its mission to deliver first- and best-in-class therapies aimed at transforming the lives of individuals facing serious health challenges. The company operates a diverse portfolio comprising approved and investigational medicines, along with innovative drug discovery initiatives, particularly in the realm of pulmonary and inflammatory conditions. Insmed is also recognized for its employment practices, continually ranked among the top employers within the biopharmaceutical sector.

Despite this setback with brensocatib, Insmed remains resolute in its approach to address unmet medical needs through its various programs, including those targeting pulmonary ailments and other serious diseases. The company’s research efforts span multiple technologies, signifying its commitment to advancing healthcare solutions in a responsible and impactful manner.

For more information about Insmed and its evolving projects, visit www.insmed.com or follow the company on platforms like LinkedIn, Instagram, YouTube, and X.