Affibody Announces First Dosing in a Phase I Trial of ABY-039 for Autoimmune Diseases

Solna, Sweden, March 13, 2018. Affibody AB (“Affibody”), a clinical stage biopharmaceutical company developing a portfolio of innovative drug projects, today announced first dosing in a Phase I proof-of-principle study of ABY-039, a potential best-in-class therapy for the treatment of B-cell driven autoimmune diseases.

“First dosing with ABY-039 marks an important step forward for both the project and Affibody as a company, and demonstrates the strength of our science driven experimental medicine model”, said David Bejker, CEO of Affibody. “We believe that ABY-039 has all the features needed to become a best-in-class treatment option for a range of B-cell driven autoimmune diseases. Today many of these diseases lack adequate treatment options and ABY-039 could potentially help many patients with chronic diseases that are inadequately controlled. The initiation of this clinical study is also an acknowledgement of the highly efficient way in which we’re utilizing our innovative proprietary platforms to rapidly generate a broad multiple product pipeline. ABY-039 is now our second clinical program following our successful Phase I/II of ABY-035.”

ABY-039 is a novel FcRn targeting agent, which has been specifically designed to utilize the strengths of Affibody’s technology platform to differentiate from competing antibody based approaches. ABY-039 is a very small protein drug (18 kDa, an eighth of an antibody) and has an in vivo half-life, as determined in animal models, exceeding that of antibody based approaches.

“ABY-039 is a differentiated molecule offering an innovative and novel approach to treat and control IgG-mediated autoimmune conditions, many of which are orphan diseases”, said Fredrik Frejd, CSO of Affibody. “ABY-039 has in animal models demonstrated rapid onset of action coupled with a sustained pharmacodynamics effect, by far exceeding alternative approaches leading us to believe that ABY-039 has the opportunity to become a very important treatment for diseases with serious unmet needs”.

The Phase I study is an adaptive double-blinded and placebo-controlled study in healthy volunteers. The objective is to evaluate the safety, tolerability and pharmacokinetics of ABY-039. The study includes pharmacodynamics markers, which are intended to aid identifying a potential dose for future Phase II/III studies.