Affibody announces dosing of the first patients in a Phase II proof-of-concept study of ABY-035 in patients with moderate-to-severe psoriasis.
“We are excited to start the dosing in this Phase II study to evaluate the safety, tolerability and efficacy of ABY-035. Psoriasis is a devastating chronic disease with a pressing need for improved therapies. We believe that ABY-035 could offer a unique new treatment paradigm for psoriasis patients and it reflects our overall commitment to developing new treatment options for patients with serious diseases”, said David Bejker, CEO of Affibody. “The initiation of this Phase II trial is an emphatic sign that our transition from a technology platform company to a clinical stage drug developing company with a broad pipeline, based on our innovative technology platform, is progressing rapidly as it follows our recent announcement of the initiation of the Phase I study of ABY-039.”
ABY-035 is a novel IL-17A targeting agent, which has been specifically designed to utilize the strengths of Affibody’s technology platform to create a very small protein drug (18 kDa, an eighth of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life.
“ABY-035 is a unique molecule with very high affinity and a novel mode of binding that may offer considerable advantages to psoriasis patients. The Phase II design is highly innovative and is fully utilizing existing knowledge from the IL-17 class to aim for very high responses”, said Fredrik Frejd, CSO of Affibody, “This unique molecule successfully demonstrates the strength of our innovative protein engineering platform, and we look forward to further characterizing its unique efficacy profile in the Phase II setting”.
The double-blinded placebo controlled Phase II proof-of-concept study will enroll approximately 100 moderate-to-severe psoriasis patients in centers all over Germany to evaluate the efficacy, safety and tolerability of ABY-035. The primary efficacy measure is PASI 90.