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EADV 2025 News: New Brivekimig Data Supports Targeting TNF and OX40L in HS

Brivekimig produced clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS), according to new phase 2a data presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, France.

Brivekimig is a dual-target Nanobody molecule inhibiting the tumor necrosis factor (TNF) and OX40-ligand. It is being investigated by Sanofi for potential uses across a range of immune-mediated diseases and inflammatory disorders.

The HS-OBTAIN phase 2a study is a randomized, double-blind, placebo-controlled, proof-of-concept study assessing the efficacy and safety of brivekimig in adults with moderate-to-severe HS. The primary analysis population included biologic-naïve HS patients who were randomized 2:1 to receive brivekimig 150mg or placebo subcutaneously every two weeks.

Observations

The following was observed at 16 weeks:

  • HiSCR50, defined as a ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline, median response rates were 67% in the brivekimig arm (n=48) vs. 37% (n=23) in the placebo arm (Bayesian primary analysis with estimated difference of 29%; 90% credible interval: 10%–47%; probability of superiority: 99.28%).
  • Clinically meaningful improvements were also seen in more stringent secondary efficacy endpoints of HiSCR75 and HiSCR90 for brivekimig vs. placebo.
  • 54% of patients treated with brivekimig achieved HiSCR75 versus 22% with placebo.
  • HiSCR90 was achieved by 31% of patients treated with brivekimig vs. 9% with placebo.
  • The mean percent change from baseline in draining tunnel count was -56.0% for brivekimig vs. +10.9% for placebo.

The most frequent adverse events (occurring in >10% of participants, and more frequent with brivekimig than with placebo) were nasopharyngitis and headache.

“Despite the debilitating impact of HS, treatment options are unfortunately limited,” says Alexa B. Kimball, MD, MPH, a Professor of Dermatology at Harvard Medical School in Boston, MA. “The phase 2a results presented at EADV indicate targeting TNF and OX40L pathways together with brivekimig may offer a promising strategy to reduce underlying inflammation, leading to improvement in HS symptoms.”