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The new oral medicine helped some patients with mild to moderate psoriasis achieve and sustain PASI-50 after the initial study period.
New data on from a phase 2 trial of EDP1815 found that the oral medicine was well tolerated in patients with mild and moderate psoriasis.
The findings were presented at the American Academy of Dermatology (AAD) 2022 Annual Meeting, and no drug-related serious adverse events were observed.
The oral, anti-inflammatory, gut-restricted commensal microbe is a non-live pharmaceutical preparation of a strain of Prevotella histicola. Pre-clinical research found that EDP1815 has anti-inflammatory effects that covered multiple inflammation pathways.
The phase 2 trial of the medicine, EDP1815-201, was a multi-center, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with mild and moderate psoriasis. It consisted of a treatment phase (Part A) and an extended follow-up phase including off-treatment (PART B).
A total of 249 participants were randomized in a 1:1:1 ratio in Part A of the tria. The 3 parallel cohorts included 1 capsule, 4 capsules, and 10 capsules of EDP1815.
From there, patients were randomized in a 2:1 ratio to active or placebo before the initial dosing.
Subjects received medications once daily for 16 weeks before being followed-up for 4 weeks after treatment and eventually to week 20. Investigators assessed PASI scores based on mean changes from baseline to responder rates.
The primary endpoint of Part A was the mean percentage change in PASI between treatment groups and placebo, and secondary endpoints included the proportion of trial participants who achieve a PASI-50 response of greater.
The 16-week endpoint data suggested that EDP1815 was superior to placebo in 80-90% of prespecified analyses and cohorts. Additionally, 25-32% of patients across the 3 cohorts treated with the medicine achieved a PASI-50 at week 16.
Regarding Part B of the trial, investigators assessed treatment response and incidence of rebound following cessation of dosing. Patients would assessed at weeks 24 and 28, and patients who achieved a PASI-50 or greater were evaluated at week 40.
During this part of the study, investigators observed no flare or rebound of psoriasis in patients. Additionally 30 of the 83 patients who had received EDP1815 in Part A and entered Part B achieved a PASI-50 or greater reduction at the end of the initial period, and 18 of those 30 patients remained at PASI-50 or greater at the end of Part B.
“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 BChir, Dermatology and Pharmacology Physician at Addenbrooke’s Hospital and Clinical Lead, Late Stage Development of Evelo. “These data, combined with positive feedback from patients and physicians, as highlighted by our recent KOL event 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.”