Evelo Biosciences, Inc. announced that its first extracellular vesicle (EV) product candidate, EDP2939, has progressed to dosing in a Phase 2 psoriasis clinical trial after completing a safety and tolerability review from a first cohort of human volunteers. Safety and tolerability assessment of multiple ascending dose cohorts continues. EDP2939-101 is a multi-center randomized, placebo-controlled, Phase 1/2 trial evaluating the safety, tolerability and clinical efficacy of EDP2939.

Part A (Phase 1) of the trial is designed to determine safety and tolerability in human volunteers at multiple ascending doses. The primary endpoints of Part A are safety endpoints: AEs, SAEs, vital signs, safety laboratory tests, and ECGs. Part B (Phase 2) is designed to determine the efficacy of EDP2939 in patients with moderate plaque psoriasis at the proposed therapeutic dose.

The primary endpoint is the proportion of patients who achieve an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) after 16 weeks of daily oral administration of EDP2939 or placebo. Secondary endpoints include several physician- and patient-reported psoriasis outcomes, as well as further safety evaluation. The trial will comprise approximately 110 patients randomized 1:1 to receive a single capsule of either EDP2939 or a matching placebo.