Sanofi’s brivekimig met the primary endpoint in a Phase IIa trial in patients naïve to biologics with moderate-to-severe hidradenitis suppurativa (HS).
New data from the HS-OBTAIN trial (NCT05849922), presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris, show that treatment with brivekimig led to clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50).
HiSCR50 is defined as ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count. In the treatment arm, there was a 67% response rate compared to 37% in the placebo arm.
In the secondary endpoints of HiSCR75 and HiSCR90 the response rate was 54% and 31%, respectively, for those treated with the subcutaneous monoclonal antibody (mAb) and 22% and 9%, respectively, for those treated with placebo.
In the brivekimig cohort, draining tunnel count reduced by 56%, while in the placebo cohort it increased by 10.9%.
Dr Alexa Kimball, Professor of Dermatology, Harvard Medical School, said: “The Phase IIa 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.”
Brivekimig was well tolerated, with no serious adverse events (AE). The most frequent AEs were nasopharyngitis and headache, occurring in >10% of patients and more frequent with brivekimig than with placebo.
Sanofi's randomised, double-blind, placebo-controlled, proof-of-concept study enrolled patients with HS, including those who were biologic-naïve.
The drug is also being investigated in patients with glomerulonephritis, type 1 diabetes, ulcerative colitis (UC) and Crohn’s disease.
HS market to grow to $7.83bn
According to a GlobalData report, the HS market across the seven major pharmaceutical markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $1.84bn in 2024 to $7.83bn in 2034. This growth is largely attributed to the launch of novel biologics and small molecules targeting multiple inflammatory pathways beyond TNF-alpha inhibition.
Only three biologics are approved for HS, AbbVie’s Humira (adalimumab), Novartis’ Cosentyx (secukinumab), and UCB’s Bimzelx (bimekizumab). Humira is the market leader in the indication, but the other two therapies have shown both higher response and a faster onset, so they could become bigger players in the coming years.
There are other therapies in development, including MoonLake Immunotherapeutics’ tri-specific nanobody targeting IL-17A/F and albumin, sonelokimab, and Incyte’s JAK1 inhibitor, povorcitinib.
In July 2025, Novartis announced it was stopping the development of ianalumabin HS after a Phase IIb proof-of-concept trial failed to meet its primary endpoint.
