The biopharmaceutical company announces the completion of enrollment in their Phase II proof-of-concept study of ABY-035 for moderate-to-severe psoriasis, AFFIRM-35.
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.
Primary and secondary endpoints
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.
“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.”