Evelo Biosciences Announces Top-Line Results From its Phase 2 Clinical Study with EDP2939 in Moderate Psoriasis

- Primary endpoint was not achieved –

- Company exploring strategic alternatives and partnering opportunities for EDP1815 and its SINTAX platform -

CAMBRIDGE, Mass., Oct. 17, 2023 (GLOBE NEWSWIRE) -- Evelo Biosciences, Inc. (Nasdaq:EVLO) (“Evelo” or the “Company”), a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced top-line results from its Phase 2 clinical study with EDP2939 in moderate psoriasis. The study’s primary endpoint, the difference in the proportion of patients who achieved an outcome of a 50% improvement from baseline in Psoriasis Area and Severity Index (PASI) score (a PASI-50 response) between EDP2939 and placebo after 16 weeks of daily treatment, was not achieved. The Company is continuing to gather and analyze the study data.

Simba Gill, Ph.D., Chief Executive Officer of Evelo, commented, “Whilst we are disappointed with the results of the Phase 2 study with EDP2939, we continue to believe in the value of our Small Intestinal Axis (SINTAX) platform and in our potential product, EDP1815. We previously reported positive efficacy and safety data in a Phase 2 study of mild to moderate psoriasis with EDP1815. We will cease development of EDP2939, given the results of this study, and are conducting a review of potential strategic alternatives, including seeking to partner EDP1815 and the SINTAX platform. I want to thank patients and investigators who participated in the study, and our team and shareholders for their support.”

In the EDP2939-101 Phase 2 study, the primary endpoint was the difference in the proportion of patients who reached at least PASI-50 reductions between EDP2939 and placebo after 16 weeks of daily treatment. A PASI-50 response was chosen as this is clinically meaningful for patients with moderate psoriasis and had been positive in the previous study with EDP1815. Although there was no statistically significant difference between the proportion of patients who achieved a PASI-50 response on EDP2939 compared to placebo, it was notable that such numeric proportion went from being inferior to placebo at week 16 (19.6% on EDP2939 vs 25% on placebo) to being superior at the week 20 follow-up visit (33.9% on EDP2939 vs 26.9% on placebo). Ongoing analysis of the secondary endpoints continues.