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February 28, 2022

Evelo’s oral biologic asset offers durable responses in Phase II psoriasis trial

In the Part A of the trial, 30 out of 83 subjects who received EDP1815 attained a PASI-50 or more at week 16.

Evelo Biosciences has reported that results from the post-treatment follow-up (Part B) of its Phase II clinical trial showed that EDP1815 provided durable and deeper clinical responses in individuals with mild-and-moderate psoriasis.

Being developed to treat various inflammatory diseases, such as psoriasis, atopic dermatitis and Covid-19, EDP1815 is an investigational oral biologic.

It is a non-live pharmaceutical formulation of a Prevotella histicola strain, chosen for its ability to offer systemic pharmacological impacts following oral dosing with gut-restricted distribution.

Named EDP1815-201, the randomised, multicentre, double-blind, parallel-cohort, placebo-controlled, dose-ranging Phase II trial analysed EDP1815 in adult mild and moderate psoriasis patients.

The trial had two parts: treatment and an extended follow-up phase.

In part A, either EDP1815 or placebo were administered to trial subjects for 16 weeks while Part B of the trial followed up these subjects for up to another 24 weeks.

A total of 83 subjects treated with EDP1815 in Part A entered Part B.

Findings showed that at week 16 of Part A, 30 subjects attained a 50% reduction in Psoriasis Area and Severity Index score from baseline (PASI-50) or more.

Furthermore, 18 and ten of the 30 subjects had PASI-50 or more and a PASI-75 or more, respectively by the Part B of the trial.

Clear skin (PGA 0) or nearly clear skin (PGA 1) was reported in 19 of the 83 subjects at the end of the first part of the trial while nine retained PGA 0/1 score at the end of Part B.

These results along with durability findings indicate that extended dosing could offer deepened responses in some subjects.

In addition, the safety and tolerability results for EDP1815 were similar to placebo in the trial without any flare or rebound observed on discontinuing the treatment.

Evelo Biosciences chief medical officer Duncan McHale said: “The totality of data from the EDP1815 Phase II trial, which includes these Part B results, and the previously reported clinical and cytokine biomarker improvements observed over the 16 week dosing period, support the potential of EDP1815 to address systemic inflammation and deliver long-lasting and clinically meaningful benefit to patients with psoriasis.

“With the clinical responses and safety and tolerability results comparable to placebo observed in trials involving over 450 patients to-date, we look forward to advancing EDP1815 towards Phase III clinical trials.”

The latest development comes after the company dosed the first participant in Phase II trial of EDP1815 for the treatment of atopic dermatitis.

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