Izokibep shows promise in early phase 2 hidradenitis suppurativa trial
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Key takeaways:
- Subjects with hidradenitis suppurativa treated with izokibep achieved high rates of Hidradenitis Suppurativa Clinical Response (HiSCR) 75 and above.
- 33% of patients achieved HiSCR 100 at week 12.
NEW ORLEANS — Izokibep, a novel interleukin-17 inhibitor, has shown dramatic responses in hidradenitis suppurativa treatment in an early phase 2 study, according to a speaker at the American Academy of Dermatology Annual Meeting.
“[Hidradenitis suppurativa (HS)] is a horrible, horrible disease with a high disease burden. It’s extremely disruptive to anyone’s personal life,” Kim A. Papp, MD, PhD, president and director of research at Probity Medical Research and one of the study’s investigators, told Healio. “There has been a drive to find more effective therapies. ... I think the results from izokibep provide hope that there may be an additional, probably more effective therapy on the horizon.”
Papp presented data from the single-arm, open-label part A of a phase 2b/3 clinical trial of 30 patients with moderate to severe HS, defined as Hurley Stage II and III disease, who receive 160 mg of izokibep subcutaneously every week.
After 12 weeks of treatment, 71% of subjects achieved a Hidradenitis Suppurativa Clinical Response (HiSCR) of 50, whereas 57% achieved HiSCR 75, 38% achieved HiSCR 90 and 33% achieved HiSCR 100.
“When you’re entering a relatively crowded sphere in early development, you need to make a decision quite quickly as to whether or not your molecular entity has the wherewithal to push the dial. I would suggest based upon the data derived from this study that indeed, it appears to be very competent,” Papp said. “The immediate implication is that the drug is certainly worth pursuing in the treatment of HS, so advancing it forward as quickly as possible through phase 2 and on to phase 3.
Adverse events were mostly mild to moderate with two patients experienced three serious events: inflammatory bowel disease in one patient and peri colonic abscess/sepsis in two patients.
Part B of the study, which is a double-blind, placebo-controlled trial, in currently ongoing, and a phase 3 trial is planned.
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Papp K, et al. Izokibep, a novel IL-17 inhibitor, demonstrated HiSCR100 response in moderate to severe hidradenitis suppurativa: Week 12 results of open-label part A of a phase 2b/3 study. Presented at: American Academy of Dermatology Annual Meeting; March 17-21, 2023; New Orleans.
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