The Phase 3 study of izokibep in HS met the primary endpoint of HiSCR75 at week 12, as well as several key secondary endpoints including HiSCR90 and HiSCR100.

Data from week 16 demonstrate deepening of responses over time with statistically significant improvement across multiple efficacy endpoints. 37% of patients treated with 160 mg izokibep weekly (QW) achieved HiSCR75 compared to 20% of patients receiving placebo (p<0.01).

In higher order endpoints, 24% of patients treated with izokibep achieved HiSCR90, compared to 12% with placebo (p<0.05), and 21% of patients treated with izokibep achieved HiSCR100, compared to 9% with placebo (p<0.01).

“Hidradenitis suppurativa is a painful, chronic disease that profoundly affects patients’ physical and emotional well-being, underscoring the urgent need for better treatments to improve outcomes and quality of life,” said presenter and principal investigator Kim Papp, M.D., Ph.D., Probity Medical Research, Inc. and Division of Dermatology, Temerty Faculty of Medicine, University of Toronto, Canada. “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”.

Significant improvement was also demonstrated in patient reported outcomes. Among patients treated with izokibep and with a baseline pain numeric rating scale (NRS) ≥4, 38% achieved a ≥3-point reduction in pain NRS compared to 17% of patients receiving placebo (p<0.01). In addition, significant improvements were seen with izokibep in Dermatology Life Quality Index, for which patients treated with izokibep had a least squares mean change from baseline of −4.4 (standard error: 0.6) compared to −2.9 (standard error: 0.5) for patients receiving placebo (p<0.05).

Izokibep was generally well-tolerated with a favorable safety profile consistent with previous studies. There were no reports of Candida infection, inflammatory bowel disease, or suicidal ideation with izokibep.

“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,” said David Bejker, Chief Executive Officer of Affibody. “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.”