Eton Pharmaceuticals plans Phase 2 mecasermin trial for pediatric epileptic spasms in Q1 2027
ETON•Eton Pharmaceuticals submitted an FDA investigational new drug application for an investigator-sponsored Phase 2 trial of mecasermin in children with refractory epileptic spasms, with initial dosing targeted for the first quarter of 2027. The University of Chicago-sponsored study plans to enroll up to 20 patients ages 2-18 at three sites.
1. Trial plans
Eton Pharmaceuticals launched ET-900 to evaluate mecasermin for infantile and epileptic spasms, targeting a new use for the active ingredient in INCRELEX. The University of Chicago-sponsored Phase 2 study will enroll up to 20 patients ages 2-18 with refractory epileptic spasms across three sites, with initial dosing targeted for the first quarter of 2027.
2. Program details
Eton submitted an FDA investigational new drug application for the investigator-sponsored trial. Licensed patent rights from Baylor College of Medicine underpin the program, and Eton retains commercial rights. Animal research reportedly showed reduced spasms, with some animals becoming spasm-free; the trial will evaluate efficacy, safety and tolerability.
