Evommune has initiated a Phase IIb clinical trial of EVO756 for the prophylactic migraine treatment with the dosing of the first patient.
EVO756 is a first-in-class, highly selective oral antagonist of the Mas-related G protein-coupled receptor X2 (MRGPRX2) found mainly on mast cells and peripheral sensory neurons.
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The randomised, global, placebo-controlled, dose-ranging, double-blind trial will enrol around 330 adults with refractory migraine, specifically those experiencing at least six migraine days per month.
Participants will be randomised to two EVO756 dose arms or placebo for 12 weeks with daily doses reaching up to 100mg.
The primary measure for the trial will be the mean change from baseline in monthly migraine days.
Additional secondary outcomes will include the proportion of patients achieving at least 50% and 75% reductions in monthly migraine days, change in monthly headache days, and acute migraine medication use.
Exploratory assessments will cover patient subtyping, migraine-related biomarker changes, and quality of life measurements.
Evommune president and CEO Luis Peña said: “Initiating this migraine trial is an exciting milestone for Evommune and for patients who remain inadequately served by current preventive therapies. While the preventive migraine market has seen progress, innovation has largely been limited to a single target and a meaningful proportion of patients continue to experience inadequate relief. A substantial opportunity remains for a front-line oral therapy with a differentiated mechanism.
“EVO756’s dual-action biology, targeting both human trigeminal neurons and meningeal mast cells, combined with its multi-neuropeptide coverage and mechanistic breadth could translate across a wide range of migraine patients, including those who have not responded adequately to CGRP inhibitors. We look forward to reporting top-line data from this trial in 2027.”
Evommune is studying EVO756 in chronic inflammatory diseases such as migraine and atopic dermatitis.
In September 2024, the company enrolled the first subject in a Phase II clinical trial of EVO756 designed to treat adults with chronic inducible urticaria.
