Affibody has announced that data from treatment with izokibep in the open label part (Part A) of a Phase 2b/3 trial in patients with moderate-to-severe Hidradenitis Suppurativa (HS) will be presented.
The data from the open label Part A, presented at the American Academy of Dermatology (AAD) Annual Meeting in New Orleans, USA, demonstrated that treatment with izokibep led to higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR) response, including unprecedented HiSCR100 responses at 12 weeks. The double-blind, placebo-controlled Part B of this Phase 2b/3 trial is ongoing.
About the trial
In the trial conducted across nine sites in the United States, 30 participants received 160 mg of izokibep dosed subcutaneously every week. The participant demographics were highly consistent with historical studies in the disease and included Hurley Stage II and III patients. At 12 weeks, 71% of participants achieved HiSCR50, 57% achieved HiSCR75, 38% achieved HiSCR90 and 33% achieved HiSCR100 – a response not previously reported for any agent in this timeframe.
“The 12-week izokibep results, including 33% of patients achieving HiSCR100, are unparalleled for moderate-to-severe hidradenitis suppurativa patients compared to historical studies,” says Nikolai Brun, CMO of Affibody. “We believe that the collective data for izokibep in psoriatic arthritis and hidradenitis suppurative demonstrate the potential of Affibody molecules such as izokibep to deliver differentiated clinically meaningful benefit for patients.”
Izokibep inhibits interleukin-17A (IL-17A) with higher potency and has the potential for greater tissue penetration due to its markedly smaller size compared to traditional monoclonal antibodies. The safety profile was consistent with previous izokibep studies, with localized mild-to-moderate injection site reactions (ISRs) being the most common adverse event. There was no evidence of increased risk of infection and there were no candida events reported through week 12.
Photo of Nikolai Brun, CMO of Affibody