Affibody announces that it has decided to initiate Phase II development with ABY-035, which is the company’s proprietary psoriasis program.
“This Affibody molecule, ABY-035, has been specifically designed to capture the unique aspects of the Affibody technology. It is a bi-specific construct with extraordinary affinity and confirmed antibody-like half-life. The initial results from our patient arms in an ongoing Phase I/II study confirm a very rapid and sustained clinical benefit for patients. With these results we have decided to advance the project into Phase II development and expect recruitment to commence during H2 2017,” says David Bejker, CEO of Affibody.
“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 very innovative and is fully utilizing existing knowledge from the IL-17 class to aim for the very high responses,” commented Professor Kristian Reich, Head of Skinflammation Centre at Dermatologikum Hamburg and psoriasis researcher.
ABY-035 is a novel IL-17A targeting agent that utilizes 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.
The first part of the ongoing Phase I/II study, included 46 healthy volunteers that were treated with escalating doses of ABY-035, in a double-blind, placebo-controlled part of the study. The first patient cohort included six patients receiving a single dose of ABY-035, in an open label part of the study. The Phase I/II study is now recruiting and dosing psoriasis patients in an open label multiple dosing arm and an additional single dose arm. The primary objective of this study is to evaluate safety, tolerability and pharmacokinetics of ABY-035.
Source: Affibody press release