The results from the Evelo Biosciences EDP1815 treatment provide the first demonstration in a phase 2 trial of the safety and efficacy of an orally-administered, gut-restricted SINTAX medicine.
Evelo Biosciences, a clinical stage biotechnology company developing SINTAX medicines as a new modality of orally delivered treatments for inflammatory disease, presented late breaking data from the phase 2 trial of EDP1815 in psoriasis at the 2022 American Academy of Dermatology Annual Meeting, held March 24 to 29, in Boston, Massachusetts.
“We are proud to join the dermatology community at AAD to share the latest data from the clinical development of EDP1815 in psoriasis. The data being shared demonstrate the potential of Evelo's SINTAX platform, and support progression towards registration trials for EDP1815,” said Douglas Maslin, MPhil, MB, B.Chir, dermatology and pharmacology physician at Addenbrooke’s Hospital and Clinical Lead, Late Stage Development at Evelo, in the press release. “These data, combined with positive feedback from patients and physicians… suggest the potential profile of EDP1815 as a safe, effective, oral, and well-tolerated therapy for psoriasis, which could address a significant unmet need for patients across all stages of disease.”
The study titled, “A phase 2 study investigating the effect of EDP1815, an orally-delivered, anti-inflammatory, gut-restricted commensal microbe in the treatment of mild and moderate plaque psoriasis,” dove into the data from the phase 2 clinical trial which evaluated EDP1815 vs placebo for the treatment of mild and moderate psoriasis. The trial had a part A, where patients received either EDP1815 or placebo for 16 weeks, and a part B, where patients were followed for up to 24 weeks after they had stopped receiving EDP1815 or placebo.
The data showed that EDP1815 was well-tolerated with safety data, with no treatment related serious adverse events, and no meaningful difference in infections or gastrointestinal events from placebo were observed.
During the 16-week dosing period, the primary endpoint analysis demonstrated EDP1815 was superior to placebo with 80-90% probability across each cohort, according to the press release. Each cohort showed increased Psoriasis Area and Severity Index (PASI) score responses, as measured by the proportion of patients achieving PASI-50 from baseline at week 16: statistically significant (p < .05) over placebo in cohorts 1 and 2. A post-hoc analysis comparing Physician Global Assessment (PGA) 0/1 response rate showed statistical significance with a rate of 20.2% compared to 9.1% in placebo (p = .048).
There were 83 patients who had received EDP1815 in part A who entered part B. For part B, patients were followed for up to 24 weeks after they had stopped treatment with EDP1815 or placebo. During the post-treatment period, durable and deepening clinical responses were observed, with no flare or rebound of psoriasis, according to the release. Of the 83 patients, 30 achieved a PASI-50 or greater reduction at the end of part A and 18 of the 30 patients remained at PASI-50 or greater at the end of part B. Also, 10 of these 30 patients achieved a PASI-75 or greater at the end of part A and 5 of them remained at PASI-75 or greater at the end of part B.
Evelo Biosciences presents late-breaking oral abstract on data from phase 2 trial of EDP1815 in psoriasis at 2022 American Academy of Dermatology Annual Meeting. Evelo Biosciences. Press release. Published March 26, 2022. Accessed March 29, 2022. https://ir.evelobio.com/news-releases/news-release-details/evelo-biosciences-presents-late-breaking-oral-abstract-data/