Evelo Biosciences, Inc. (NASDAQ:EVLO), a clinical stage biotechnology company developing a new modality of orally delivered, systemically acting biologics, today announced that it has dosed the first patients in its Phase 2 clinical trial evaluating EDP1815 for the treatment of mild to moderate psoriasis. EDP1815 is an investigational oral biologic in development for the treatment of inflammatory diseases including psoriasis, atopic dermatitis, and COVID-19.
“We are pleased to announce the dosing of the first patients in our Phase 2 clinical trial in mild to moderate psoriasis,” said Duncan McHale, M.B.B.S., Ph.D., Chief Medical Officer of Evelo. “In Phase 1b studies, EDP1815 demonstrated an ability to resolve systemic inflammation and provide clinical benefit to patients with psoriasis. Based on these data, EDP1815 may offer an improved profile to existing products and others in development. EDP1815 has the potential to be an effective, well-tolerated, and convenient medicine for millions of patients with mild to moderate psoriasis. Our Phase 2 trial, if successful, will enable us to advance into confirmatory registrational studies, following meetings with health authorities such as the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). We look forward to interim data by mid-2021, as we continue to progress this important therapy toward market.”
EDP1815-201 is a double-blind, placebo-controlled, dose-ranging Phase 2 trial designed to evaluate three doses of the enteric capsule formulation of EDP1815 versus placebo in 225 patients with mild to moderate psoriasis over a 16-week treatment period. The primary endpoint is mean reduction in Psoriasis Area and Severity Index (PASI) score at 16 weeks. Key secondary endpoints include other clinical measures of disease such as Physician’s Global Assessment (PGA), Body Surface Area (BSA), PGA x BSA, Psoriasis Symptom Inventory (PSI), Dermatology Life Quality Index (DLQI), and Lesion Severity Score (LSS). Interim data from the study is expected by mid-2021.