Evelo Biosciences, a clinical stage biotechnology company developing a novel platform of orally delivered inflammation-resolving medicines acting on the small intestinal axis (SINTAX), today announced updates to its clinical programs.
“In the fourth cohort of the study of EDP1815 in atopic dermatitis, consistent with the first three cohorts, the primary endpoint was not met. The primary endpoint was the proportion of patients who achieve an EASI-50 response at week 16,” said Simba Gill, Ph.D., CEO of Evelo. “Given these results, we will cease further development of EDP1815 in atopic dermatitis, following a wind-down of the study. We will focus resources on the next generation extracellular vesicle (EV) platform and on EDP2939, our first EV candidate, currently in a Phase 1/2 study in psoriasis. The faster release formulation of EDP1815, dosed in cohort 4, was generally well tolerated. The potential impact on efficacy of the faster release formulation cannot be determined from this study.”
Dr. Gill continued, “In preclinical studies, EVs have shown substantially more potent activity than EDP1815. We believe that this, together with our previously reported positive Phase 2 clinical data in psoriasis with EDP1815, supports the potential of EDP2939, if approved, to be an attractive and unique foundational oral treatment to address all stages of psoriasis and other Th1/Th17 driven inflammatory diseases, including psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis and inflammatory bowel disease. We believe EDP2939 may have greater potential activity than EDP1815 in psoriasis, with similar tolerability. The Phase 2 study of EDP2939 in moderate psoriasis is now fully enrolled, and we expect to report topline results early in the fourth quarter of this year.”
“We are prioritizing investment in the EV platform and in EDP2939 clinical development and are reducing our workforce to save costs. I would like to express my sincere thanks to the patients and clinicians involved in our studies and to our team for advancing our programs,” Dr. Gill stated.
EDP1815 Phase 2 in Atopic Dermatitis – Topline Data
- The fourth cohort of the EDP1815-207 trial did not meet the primary endpoint of the proportion of patients who achieve an outcome of at least a 50% improvement from baseline in Eczema Area and Severity Index (EASI) score, an EASI-50 response, compared to placebo at week 16.
- EASI-50 responses or greater were achieved at week 16 in 37.9% of patients dosed with EDP1815 versus 44.7% on placebo in the fourth cohort.
- EDP1815 faster release capsule was generally well tolerated.
EDP2939 Phase 1/2 in Psoriasis
- Enrollment is complete in the Phase 2 portion of EDP2939-101, the first study of extracellular vesicles in moderate psoriasis.
- Topline data from the Phase 2 portion of the study is expected to be reported early in the fourth quarter of 2023.
- The safety review committee reviewed data for the completed cohorts 1 and 2 of the Phase 1 healthy volunteer portion of the study and reported no notable safety or tolerability concerns.
Source – Globe Newswire