08:54:01 Europe / Stockholm


2023-03-18 15:00:00

• At 12 weeks, 57% of patients achieved HiSCR75, 38% achieved HiSCR90 and 33% achieved HiSCR100.
• Safety results were consistent with previous trials of izokibep, with no increased risk of infections.

Solna, Sweden, March 18, 2023. Affibody today announced that topline 12-week 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 in a Late-Breaking plenary session at the American Academy of Dermatology (AAD) Annual Meeting in New Orleans, USA.
The data from the open label Part A 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.
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,” said 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.
The data will be presented by Kim A. Papp, MD, FAAD, in a Late-Breaking plenary session at the American Academy of Dermatology (AAD) Annual Meeting on March 18, 2023. The title of the presentation is: “Izokibep, a Novel IL-17A Inhibitor, Demonstrates HiSCR100 Responses in Moderate-to-Severe Hidradenitis Suppurativa: Open-Label Part A Results of a Phase 2b/3 Study”.

About Hidradenitis Suppurativa
Hidradenitis suppurativa (HS) is a chronic Inflammatory skin disease causing scarring, abscesses, malodor, and pain. HS typically occurs in areas with high concentrations of sweat glands and is typically accompanied by pain, malodor, drainage, and disfigurement that contribute to disability and a devastating impact on quality of life. Patients with HS miss a greater number of days of work and have increased disability compared to the average population.
HiSCR measures response to treatment in HS with HiSCR50 indicating at least a 50% reduction in total abscess and inflammatory nodule count (AN count), with no increase in abscess count, and no increase in draining fistula count relative to baseline. Higher orders such as HiSCR75, HiSCR90, and HiSCR100 indicate 75%, 90%, and 100% reduction respectively.