Evelo Biosciences Misses Trial Endpoint in Blow to Psoriasis Community
Evelo Biosciences (Nasdaq: EVLO) has missed the primary endpoint in its Phase 2 clinical study of 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.
Simba Gill, Ph.D., Chief Executive Officer of Evelo, said, “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. I want to thank patients and investigators who participated in the study, and our team and shareholders for their support.”
EDP2939-101 is a multi-center randomized, placebo-controlled, Phase 1/2 trial evaluating the safety, tolerability and clinical efficacy of EDP2939.
The primary endpoint in the study was not achieved. Secondary endpoints include several physician and patient-reported psoriasis outcomes, as well as further safety evaluation.
The trial comprised approximately 106 patients randomized 1:1 to receive a single capsule of either EDP2939 or a matching placebo.
EDP2939 was well-tolerated with adverse events (AEs) comparable to placebo.
Based on these results, Evelo has initiated a process to explore strategic alternatives.
About Evelo Biosciences
Evelo Biosciences is a clinical stage biotechnology company developing a novel platform of orally delivered anti-inflammatory medicines acting on the small intestinal axis, SINTAX, with systemic therapeutic effects. The small intestine plays a central role in governing inflammation throughout the body. The Company’s product candidates are pharmaceutical preparations of single strains of microbes or their extracellular vesicles (EVs). Evelo’s vision is to create therapies that are effective, safe, well-tolerated, and affordable to improve the lives of the billions of people living with inflammatory diseases. If shown to be effective in inflammatory disease mediated by the Th1, Th2 or Th17 inflammatory pathways, these same investigational medicines could be effective in additional inflammatory diseases, such as psoriatic and other forms of arthritis, asthma, allergy, and inflammatory bowel disease. For more information, please visit www.evelobio.com.