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Affibody Completes Enrollment in Phase 2 Psoriasis Trial of ABY-035

Pressmeddelande   •   Feb 20, 2019 09:00 CET

Solna, Sweden, February 20, 2019. Affibody AB (“Affibody”), a clinical stage biopharmaceutical company developing a pipeline of innovative drug projects, today announced the completion of enrollment in the Company’s Phase 2 proof-of-concept study of ABY-035 for moderate-to-severe psoriasis (“AFFIRM-35”).

“We are pleased that the Phase 2 AFFIRM-35 study with ABY-035 is now fully recruited. This study has been designed using the accumulated knowledge of the IL-17 field to fully explore the unique opportunity that ABY-035 represents. We look forward to the trial results and hope that ABY-035 will become a new treatment paradigm of choice for psoriasis and psoriatic arthritis patients”, said David Bejker, CEO of Affibody. “Now with approximately 300 subjects dosed, Affibody has completed the transition from a technology platform company to a clinical stage, drug development company with a broad pipeline.”

The double-blind, placebo controlled, Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) enrolled 100 moderate-to-severe psoriasis patients in centers throughout Germany to evaluate the efficacy, safety and tolerability of ABY-035. The primary efficacy measure is PASI 90 at twelve weeks. Secondary endpoints include absolute and relative PASI-measures at weeks 12, 24, and 52; DLQI; itch and pain VAS; safety and tolerability, and pharmacokinetics.

Affibody is a clinical stage Swedish biotech company with a broad product pipeline focused on developing innovative next generation biopharmaceuticals based on its unique proprietary technology platforms: Affibody® molecules and Albumod™.

The company operates a focused experimental medicine model and currently has three clinical stage proprietary programs. The first two are therapeutic programs that targets psoriasis, and B-cell driven autoimmune diseases respectively. The third program is a diagnostic imaging program that is directed primarily towards metastatic breast cancer.

In addition, to its portfolio of innovative drug projects the company offers the half-life extension technology, Albumod™, for outlicensing.

Affibody has ongoing commercial relationships with several companies such as AbClon, Biotest, Daewoong, Daiichi Sankyo, GE Healthcare, and Swedish Orphan Biovitrum.

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