Solna, Sweden, May 4, 2016. Affibody AB (“Affibody”) today announced that it has completed the dose-escalation part of a Phase I study of ABY-035, which is the company’s proprietary psoriasis program. Initial results confirm compound to be safe and well-tolerated across all doses in healthy volunteers.
“The preliminary results in healthy volunteers obtained from our first-in-human study with ABY-035 are encouraging. We will now proceed with the study and dose psoriasis patients, as a favorable safety and tolerability profile has been demonstrated. We saw extended pharmacokinetic (PK) profiles across the dose ranges that were consistent with our expectations,” says David Bejker, CEO of Affibody. “These results confirm the potential of ABY-035 to become a successful and differentiated therapy for the treatment of psoriasis and other IL-17A driven diseases.”
ABY-035 is a novel IL-17A targeting agent that utilizes 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. These features will enable significantly lower doses than with conventional antibody approaches and opens up the opportunity to explore alternative administration routes.
The first part of the Phase I study, which included 30 healthy volunteers that were treated with escalating doses of ABY-035, is a double-blind, placebo-controlled study. The Phase I study will now continue and include psoriasis patients to evaluate early signs of efficacy. The primary objective of the study is to evaluate safety, tolerability and pharmacokinetics of ABY-035.
“The preliminary results in healthy volunteers obtained from our first-in-human study with ABY-035 are encouraging. We will now proceed with the study and dose psoriasis patients, as a favorable safety and tolerability profile has been demonstrated. We saw extended pharmacokinetic (PK) profiles across the dose ranges that were consistent with our expectations,” says David Bejker, CEO of Affibody. “These results confirm the potential of ABY-035 to become a successful and differentiated therapy for the treatment of psoriasis and other IL-17A driven diseases.”
ABY-035 is a novel IL-17A targeting agent that utilizes 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. These features will enable significantly lower doses than with conventional antibody approaches and opens up the opportunity to explore alternative administration routes.
The first part of the Phase I study, which included 30 healthy volunteers that were treated with escalating doses of ABY-035, is a double-blind, placebo-controlled study. The Phase I study will now continue and include psoriasis patients to evaluate early signs of efficacy. The primary objective of the study is to evaluate safety, tolerability and pharmacokinetics of ABY-035.
