India Pharma Outlook Team | Thursday, 18 September 2025
New data from the HS-OBTAIN phase 2a study (NCT05849922) that has been released today at the EADV 2025 Congress in Paris shows that the investigational therapy brivekimig has most significantly improved the region of skin disease in patients with moderate-to-severe hidradenitis suppurativa (HS) who are naïve to biologics.
At week 16, 67% of brivekimig-treated patients met the skin disease improvement endpoint HiSCR50 (minimum 50% reduction in abscesses and inflammatory nodules with no worsening draining fistulas) compared to 37% on placebo. The primary analysis in the Bayesian framework indicates a 29% estimated difference, with a 99.28% probability of superiority.
Clinically meaningful increases were also reported in more stringent secondary endpoints, such that 54% met HiSCR75 versus 22% on placebo, and 31% achieved HiSCR90 versus 9%. Brivekimig also demonstrated a 56% reduction in draining tunnels compared to 10.9% increase on placebo.
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“The positive early-stage results for brivekimig in HS presented at EADV exemplify our deep understanding of pathway biology and commitment to exploring novel platforms and technologies with the goal of delivering new treatment options that can address the complex, heterogeneous nature of chronic inflammatory skin diseases,” said Alyssa Johnsen, MD, PhD, global therapeutic area head, immunology and oncology development at Sanofi.
Developed by Sanofi, brivekimig is a dual-target Nanobody that blocks two essential drivers of immune-mediated inflammation, tumor necrosis factor and OX40 ligand. Although brivekimig is investigational in HS, the early data suggests that it has the potential to target this debilitating condition which affects nearly 196,000 adults in the EU.
