Evelo announces primary endpoint was not achieved in Phase 2 study of EDP2939

Evelo Biosciences 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 score 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 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.” 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 to being superior at the week 20 follow-up visit. Ongoing analysis of the secondary endpoints continues. Overall safety data was consistent with what was previously reported in the Phase 1 portion of this study: EDP2939 was well-tolerated with adverse events comparable to placebo. There were no related serious adverse events. Based on these results, Evelo has initiated a process to explore strategic alternatives.