Biopharmaceutical company Insmed Incorporated (Nasdaq:INSM) disclosed on Tuesday that the Phase 2b CEDAR study, which evaluated brensocatib in adult patients with moderate to severe hidradenitis suppurativa (HS), did not meet its primary or secondary efficacy endpoints in either the 10 mg or 40 mg treatment arms.
Insmed noted that brensocatib was well tolerated, with no new safety signals identified, including in the 40 mg arm, which is the highest dose the company has studied to date. Insmed will discontinue its development programme of brensocatib in HS, and intends to present these data at a future congress.
CEDAR was a randomised, double-blind, placebo-controlled, Phase 2b study to evaluate the efficacy and safety of brensocatib in adults with moderate to severe hidradenitis suppurativa. The study enrolled 214 patients at 72 sites globally. In the study, participants were randomised 1:1:1 to receive brensocatib 10 mg, brensocatib 40 mg, or placebo, once daily for 16 weeks. After the first 16 weeks, participants either continued the same randomised dose of brensocatib, or if on placebo, were randomised to receive brensocatib 10 mg or 40 mg. The primary endpoint was percentage change from baseline in total abscess and inflammatory nodule (AN) count at Week 16.
At Week 16, study participants experienced a 45.5% and 40.3% reduction from baseline in total abscess and inflammatory nodule (AN) count in the brensocatib 10 mg and 40 mg arms, respectively, compared to a 57.1% reduction in the placebo arm.
Insmed reports Phase 2b study of brensocatib did not meet efficacy endpoints
Gilead to acquire Tubulis to expand ADC oncology capabilities
FDA grants Fast Track status to SIM0505 for platinum‑resistant ovarian cancer
Sanofi reports positive phase 2 results for lunsekimig in asthma and CRSwNP
Aelis Farma secures EUR458k France 2030 grant to advance metabolic disease programme
Immedica Pharma gains European approval to extend Efmody use in adrenal insufficiency
NeuroSense's PrimeC composition receives Brazilian patent
AstraZeneca reports positive Phase III data for Imfinzi and Imjudo in liver cancer
Thermo Fisher Scientific unveils CHOvantage GS Kit to speed biologics development
Frontier Medicines licenses FMC-220 oncology programme to LG Chem in global deal
NJ Bio and Aji Bio-Pharma partner to strengthen support for ADC development
Alltrna granted approval for first-in-human clinical trial of AP003
Lilly to acquire Centessa Pharmaceuticals for up to USD47 per share