Solna, Sweden, July 16, 2019. Affibody AB (“Affibody”), a clinical stage biopharmaceutical company developing a pipeline of innovative drug projects, today announced the completion of the planned 12 week interim analysis in the Company’s Phase 2 proof-of-concept study of its bispecific molecule ABY-035 for moderate-to-severe psoriasis (“AFFIRM-35”).
“Our Phase 2 AFFIRM-35 study with ABY-035 has now reached the stage where we are starting to see the first results”, said David Bejker, CEO of Affibody. “These interim results are very encouraging and we continue to believe that ABY-035 may be a best-in-class option for psoriasis and psoriatic arthritis patients.”
The double-blind, placebo controlled, 52 week Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) will now continue to completion which is expected in the first half of 2020. Eligible patients are offered to continue in a one year extension.
“ABY-035 is a unique multivalent and bispecific molecule, targeting both subunits of IL-17 as well as albumin and the Phase 2 AFFIRM-35 study is designed to take full advantage of the strengths of the dual targeting ABY-035. The efficacy and safety results seen in this 12 week interim analysis are highly competitive with a high number of PASI 90 responders as well as a solid safety profile”, commented Professor Fredrik Frejd, CSO of Affibody.
ABY-035 is a novel bispecific agent potently targeting both subunits of IL-17A as well as albumin (both targets being prevalent in psoriatic skin) 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 the size of an antibody) with very high apparent affinity to IL-17A (KD ~300fM) and antibody-like half-life.
ABY-035 is currently being evaluated in a double-blind, placebo controlled, 52 week Phase 2 proof-of-concept study (AFFIRM-35, NCT03591887) which has enrolled 108 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. For additional information about the Phase 2 study, please visit www.clinicaltrials.gov (NCT03591887).
In a Phase 1/2 study, ABY-035 has already demonstrated favorable safety and tolerability across multiple doses and dosing regimens with rapid and sustained efficacy in patients. The primary objective of this study was to evaluate mechanism of action, safety, tolerability and pharmacokinetics of ABY-035. For additional information about the Phase 1/2 study, please visit www.clinicaltrials.gov (NCT02690142).
Affibody is a clinical stage Swedish biotech company with a broad product pipeline focused on developing innovative bi- and multi-specific 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.
Affibody has ongoing commercial relationships with several companies such as AbClon, Alexion, Biotest, Daewoong, Daiichi Sankyo, GE Healthcare, and Swedish Orphan Biovitrum.
Further information can be found at: www.affibody.com