The company anticipates topline data in the first half of 2023. EDP1815 is a non-live pharmaceutical formulation of a strain of Prevotella histicola.
The randomised, double-blind, multicentre, placebo-controlled trial will analyse EDP1815 to treat patients with mild, moderate, and severe atopic dermatitis for 16 weeks.
Nearly 300 subjects will be enrolled across nearly 60 study centres across the globe. These patients will be randomised into one of three groups.
Each cohort will have nearly 100 subjects who will be randomised into a 3:1 ratio with 75 people receiving EDP1815 treatment and 25 receiving placebo.
Subjects in cohort 1 will be given a dose of 1.6 x 1011 total cells of EDP1815 or placebo in the form of two capsules once a day.
Cohorts 2 and 3 will receive 6.4 x 1011 total cells of EDP1815 or placebo given as two capsules once a day or one capsule twice a day, respectively.
The percentage of subjects attaining an EASI-50 at week 16 is the primary endpoint of the trial.
Investigator Global Assessment and Body Surface Area are the trial’s crucial physician-reported secondary endpoints.
The important subject-reported secondary endpoints are Dermatology Life Quality Index, Patient-Oriented Eczema Measure and Pruritus-Numerical Rating Scale.
Evelo chief development officer Jonathan Zung said: “We are pleased that dosing has begun in the Phase II trial to evaluate the potential of this novel product candidate to benefit people worldwide who are living with atopic dermatitis.
“Our previously released Phase Ib data, together with the positive results we recently released from our Phase II trial in mild and moderate psoriasis, demonstrate that EDP1815 has the potential to be a safe, effective, well-tolerated, oral, inflammation resolving therapy.”
An investigational oral therapy, EDP1815 is being developed to treat inflammatory ailments.
P. histicola it was chosen for its ability to offer systemic pharmacological effects following administration orally with gut-limited distribution.
EDP1815 was not found to colonise the gut or alter the microbiome as it is non-live.