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Press Release: EADV: Sanofi's brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study
Globenewswire· 2025-09-17 05:00
Core Insights - Sanofi's brivekimig demonstrated positive results in the HS-OBTAIN phase 2a study for treating moderate-to-severe hidradenitis suppurativa (HS), showing clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) [1][3][6] - The study indicated that brivekimig was well tolerated, with no serious adverse events reported [1][4] - The results will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris [1] Study Details - The HS-OBTAIN study was a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of brivekimig in biologic-naïve adults with moderate-to-severe HS [3][8] - Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks, followed by a 12-week open-label period and an 8-week safety follow-up [9] - The primary efficacy endpoint was the percentage of participants achieving HiSCR50 at week 16, with additional endpoints including HiSCR75, HiSCR90, and draining tunnel count [9] Efficacy Results - At week 16, 67% of patients in the brivekimig group achieved HiSCR50 compared to 37% in the placebo group, with a probability of superiority of 99.28% [7] - For HiSCR75, 54% of patients treated with brivekimig achieved this endpoint versus 22% with placebo [7] - HiSCR90 was achieved by 31% of patients in the brivekimig group compared to 9% in the placebo group [7] - The mean percent change from baseline in draining tunnel count was -56.0% for brivekimig versus +10.9% for placebo [7] Company Commitment - Sanofi emphasizes its commitment to addressing underlying inflammation in chronic inflammatory skin diseases through innovative treatments like brivekimig [5][6] - The company is exploring brivekimig's potential across a range of immune-mediated diseases [6][10]
Press Release: EADV: Sanofi’s brivekimig achieved positive results in hidradenitis suppurativa in phase 2a study
Globenewswire· 2025-09-17 05:00
Core Insights - Sanofi's brivekimig demonstrated positive results in the phase 2a HS-OBTAIN study for treating moderate-to-severe hidradenitis suppurativa (HS) [2][4][10] - The treatment showed clinically meaningful improvements in the primary endpoint, HiSCR50, with a median response rate of 67% in the brivekimig group compared to 37% in the placebo group [8] - Brivekimig was well tolerated, with no serious adverse events reported, and the most common adverse events were nasopharyngitis and headache [5][6] Study Details - The HS-OBTAIN study was a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of brivekimig in biologic-naïve adults with moderate-to-severe HS [10][11] - Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks [11] - Key secondary endpoints also showed significant improvements, with 54% of patients achieving HiSCR75 and 31% achieving HiSCR90 in the brivekimig group compared to 22% and 9% in the placebo group, respectively [8] Mechanism and Future Directions - Brivekimig is a dual-target Nanobody® molecule that inhibits tumor necrosis factor (TNF) and OX40-ligand, which are crucial in inflammatory pathways [7][9] - The results indicate that targeting both TNF and OX40L pathways may provide a promising strategy for reducing inflammation in HS [4][6] - Sanofi is committed to exploring brivekimig further and its potential impact on chronic inflammatory skin diseases [6][12]