Eton Pharmaceuticals, Inc. announced the initiation of the ET-900 development program on November 2, 2026. The program aims to evaluate mecasermin injection for the treatment of infantile and epileptic spasms. Mecasermin is the active ingredient in Eton’s marketed product INCRELEX, a recombinant form of insulin-like growth factor 1 (IGF-1).
To advance the program, Eton entered into a license agreement with Baylor College of Medicine. This agreement grants the company rights to patent protections covering the use of IGF-1 for treating spasms. The company noted that research led by Dr. John W. Swann at Baylor, funded by CURE Epilepsy, demonstrated that IGF-1 therapy reduced daily spasm counts by approximately 50% and eliminated spasms in 20% of treated animals.
Eton has submitted a research Investigational New Drug (IND) application to the U.S. Food and Drug Administration. The IND supports an investigator-sponsored Phase 2 clinical study. The study is designed to evaluate the efficacy, safety, and tolerability of mecasermin in children with refractory epileptic spasms. The trial will be conducted at the University of Chicago, Baylor College of Medicine, and UCLA. It is expected to enroll up to 20 patients aged 2 to 18 years who have not responded to hormonal therapy or vigabatrin.
Patients in the study will receive twice-daily subcutaneous injections during an initial three- to five-week treatment period. The study will assess spasm resolution, changes in spasm frequency, and EEG abnormalities. Initial enrollment and patient dosing are targeted for the first quarter of 2027.
Eton retains commercial rights to the ET-900 product candidate. The company stated that the program aligns with its strategic entry into the pediatric neurology therapeutic area. Mecasermin is not currently FDA-approved for the treatment of infantile or epileptic spasms, and its safety and efficacy for these uses have not been established.
