Izokibep shows early promise in hidradenitis suppurativa
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Key takeaways:
- A 75% improvement in HiSCR was achieved in 33% of patients with hidradenitis suppurativa treated with izokibep at week 12.
- Preliminary week 16 data showed continued improvement in these patients.
Izokibep exhibited statistically significant improvement in hidradenitis suppurativa, according to topline phase 3 trial results announced in a press release by Affibody and Acelyrin.
The multicenter, randomized, double-blind, placebo-controlled trial included 258 patients receiving 160 mg of izokibep, a small protein Affibody therapeutic designed to inhibit interleukin 17, or placebo every week.
After 12 weeks of treatment, 33% of patients achieved at least a 75% improvement in Hidradenitis Suppurativa Clinical Response (HiSCR75), compared with 21% of patients in the placebo arm (P = .0294).
Additionally, HiSCR90 and HiSCR100 was reached by 25% and 22% of treatment-arm patients vs. 9% and 8% of those in the placebo arm, respectively (P = .0009 and P = .001).
Dosing continued through week 16, with 40% of patients in the treatment group achieving HiSCR75, 27% reaching HiSCR90 and 25% achieving HiSCR100, according to preliminary data.
There were no new safety signals and the favorable safety profile seen in previous trials was maintained.
“We are pleased that the phase 3 HS trial of izokibep met its primary endpoint and provided clinically meaningful responses as early as week 12 in this devastating disease. Importantly, we are further encouraged by the deepening responses seen at week 16, with a quarter of the patients achieving HiSCR100. Past experience tells us these responses will deepen even further with continued treatment,” Nikolai Brun, MD, PhD, chief medical officer of Affibody, said in the release.
The company also announced it will continue its phase 3 programs targeting izokibep in HS and psoriatic arthritis, but will not be initiating additional phase 3 studies for these indications. An ongoing phase2b/3 trial in uveitis is still planned.
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