Affibody has reported positive 16-week data from a global Phase 3 trial of izokibep in hidradenitis suppurativa (HS), presented at the European Academy of Dermatology & Venereology Congress (EADV) in Paris.

The study met its primary endpoint of HiSCR75 at week 12, as well as secondary endpoints including HiSCR90 and HiSCR100. At week 16, 37% of patients treated with 160 mg izokibep weekly achieved HiSCR75 compared with 20% of patients on placebo (p<0.01).

Higher-level responses were also reported, with 24% of patients on izokibep reaching HiSCR90 versus 12% on placebo (p<0.05), and 21% achieving HiSCR100 versus 9% with placebo (p<0.01).

Kim Papp, principal investigator at Probity Medical Research and the University of Toronto, said: “Hidradenitis suppurativa is a painful, chronic disease that profoundly affects patients’ physical and emotional well-being. The statistically significant and clinically relevant responses demonstrated for izokibep across multiple efficacy endpoints, especially in higher-order responses with over 1 in 5 izokibep-treated patients achieving HiSCR100, are very encouraging and can mean a real difference for the significant number of patients debilitated by HS.”

Patient-reported outcomes also showed benefit. Among patients with baseline pain scores of ≥4, 38% achieved a ≥3-point reduction compared with 17% of those on placebo (p<0.01). Quality of life improved as measured by the Dermatology Life Quality Index, with izokibep patients showing a mean change from baseline of −4.4 compared with −2.9 for placebo (p<0.05).

Izokibep was well tolerated with a safety profile consistent with earlier studies. No cases of Candida infection, inflammatory bowel disease or suicidal ideation were reported.

David Bejker, chief executive officer of Affibody, added: “We are very pleased with the izokibep 16-week data in HS demonstrating deepening of responses with time and significant improvement in hard-to-reach endpoints. With its strong Phase 3 results, clear path to approval, and compelling product profile, we believe izokibep can become a game-changing drug bringing new hope to patients.”