Eton Pharmaceuticals announced ET-900, a new development program to evaluate mecasermin injection for the treatment of infantile and epileptic spasms. The company has entered into a license agreement with Baylor College of Medicine for patent rights covering the use of insulin-like growth factor 1 (IGF-1) for this indication. An Investigational New Drug (IND) application has been submitted to the FDA to begin a Phase 2 clinical study.
Key Details
- Development Program: ET-900 will evaluate mecasermin, a recombinant form of IGF-1 and the active ingredient in Eton's marketed drug INCRELEX®, for a potential new indication.
- Licensing Agreement: Eton has licensed patent rights from Baylor College of Medicine related to the use of IGF-1 for the treatment of spasms.
- Clinical Trial: A research IND has been submitted for an investigator-sponsored Phase 2 study to evaluate mecasermin in up to 20 children with refractory epileptic spasms.
- Timeline: Initial patient enrollment and dosing for the Phase 2 study are targeted for the first quarter of 2027.