Solna, Sweden, January 5, 2023. Affibody’s partner ACELYRIN, Inc. today announced top-line 12-week open label data from a Phase 2b/3 trial of izokibep in patients with moderate-to-severe Hidradenitis Suppurativa (HS).
• Izokibep achieves higher orders of Hidradenitis Suppurativa Clinical Responses (HiSCR) in an open label part of the ongoing Phase 2b/3 trial.
• Safety results consistent with previous trials of izokibep and the IL-17Ai class, with no increased risk of infection, including candida infections.
The 30-patient open label Part A of the Phase 2b/3 trial (NCT05355805) evaluated clinical response and safety of izokibep administered via subcutaneous injection to patients with moderate-to-severe HS. Izokibep demonstrated higher orders of Hidradenitis Suppurativa Clinical Responses, where low-to-no placebo responses have been reported historically. The safety data reported were consistent with previous trials of izokibep as well as the IL-17Ai class. Notably, there was no evidence of increased risk of infection and no candida infections were reported in this trial.
The full data from Part A of this trial will be presented at a future scientific meeting. The double-blind, placebo-controlled Part B of this Phase 2b/3 trial is ongoing, and based on the Part A results, ACELYRIN will accelerate initiation of the second confirmatory trial in HS.
About Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS) is an autoimmune disease characterized by inflammation of the exocrine glands and leading to skin abscesses, pain, scarring, malodor, and a devasting impacting on patient’s ability to perform ordinary daily tasks and quality of life. HS is typically painful and may significantly limit everyday activities, for instance, walking, hugging, moving, and sitting down.
Izokibep has been administered to over 300 patients, some for up to three years. It is a small therapeutic protein inhibitor of interleukin-17A (IL-17A) designed to overcome the limitations of monoclonal antibodies. With high potency and small molecular size – about one tenth the size of a traditional monoclonal antibody – izokibep can reach high drug exposure levels through a single, subcutaneous injection that monoclonal antibodies otherwise require IV administration to achieve.
Izokibep is based on Affibody’s proprietary technology platform, Affibody® molecules, and has been partnered with Inmagene Biopharmaceuticals Co. Ltd. and ACELYRIN Inc. Affibody has retained the marketing rights for the Nordic countries.