01—Abstract
Summary
Summary of the 8-K filed April 7, 2026. Cited figures are marked; the original filing is the authoritative source.
Insmed Incorporated (Nasdaq: INSM) announced on April 7, 2026 topline results from its Phase 2b CEDAR study of brensocatib in adults with moderate to severe hidradenitis suppurativa (HS).
The study did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg arms. The primary endpoint was percent change from baseline in total abscess and inflammatory nodule (AN) count at Week 16. At Week 16, AN count fell 45.5%a in the 10 mg arm and 40.3% in the 40 mg arm, versus a 57.1% reduction in the placebo arm.
The company reported that brensocatib was well tolerated, with no new safety signals identified, including in the 40 mg arm, which is the highest dose Insmed has studied to date. Treatment-emergent adverse event rates were 55.4%b (41 of 74) in the 10 mg arm, 42.9% (30 of 70) in the 40 mg arm, and 45.7% (32 of 70) in the placebo arm. One severe TEAE occurred in the 10 mg arm, and serious TEAEs were reported in 4.1% (3 of 74) of the 10 mg arm, 1.4% (1 of 70) of the 40 mg arm, and 1.4% (1 of 70) of the placebo arm.
Insmed will discontinue its development program of brensocatib in HS and intends to present the data at a future congress. The company framed the CEDAR study as a proof-of-concept study, noting that the lack of established animal models makes HS development particularly challenging.
02—Key points
Key Highlights
- Phase 2b CEDAR study of brensocatib in moderate to severe HS did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg arm.
- At Week 16, AN count reduction was 45.5% (10 mg) and 40.3% (40 mg), compared with 57.1% in the placebo arm.
- The study enrolled 214 patients at 72 sites globally and randomized participants 1:1:1 to brensocatib 10 mg, brensocatib 40 mg, or placebo, once daily for 16 weeks.
- Brensocatib was well tolerated, with no new safety signals identified, including at the 40 mg dose, the highest dose Insmed has studied to date.
- Any TEAE rates were 55.4% (10 mg), 42.9% (40 mg), and 45.7% (placebo); one severe TEAE occurred in the 10 mg arm and none in the other arms.
- Insmed will discontinue its development program of brensocatib in HS.
- Data will be presented at a future congress.
03—Questions
Frequently Asked Questions
What were the main results of the CEDAR study?
The study did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg arm. At Week 16, the AN count reduction was 45.5% in the 10 mg arm and 40.3% in the 40 mg arm, compared with 57.1% in the placebo arm.
Is Insmed continuing development of brensocatib for hidradenitis suppurativa?
No. Insmed will discontinue its development program of brensocatib in HS.
What was the safety profile of brensocatib in the study?
The company said brensocatib was well tolerated with no new safety signals identified, including in the 40 mg arm. Any TEAEs occurred in 55.4% of the 10 mg arm, 42.9% of the 40 mg arm, and 45.7% of the placebo arm. Serious TEAEs occurred in 4.1% (10 mg), 1.4% (40 mg), and 1.4% (placebo).
How was the CEDAR study designed?
CEDAR was a randomized, double-blind, placebo-controlled Phase 2b study enrolling 214 patients at 72 sites globally. Participants were randomized 1:1:1 to brensocatib 10 mg, brensocatib 40 mg, or placebo, once daily for 16 weeks, with the primary endpoint being percent change from baseline in total AN count at Week 16.
When will the full CEDAR data be presented?
The filing says Insmed intends to present the data at a future congress, without naming a specific date.
04—Continue