Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin/IGF-1 for Treatment of Infantile and Epileptic Spasms
Key Highlights
- ➤Eton licensed Baylor patent rights for IGF-1 treatment of infantile and epileptic spasms
- ➤FDA IND submitted for investigator-sponsored Phase 2 study in refractory epileptic spasms
- ➤First patient dosing targeted for Q1 2027 across up to 20 patients
- ➤Animal study reduced daily spasm counts approximately 50%; eliminated spasms in 20%
Expert Statements
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“These spasms can have devastating and lifelong consequences for children and their families, and there remains a significant and urgent need for new therapeutic approaches due to high rates of resistance to current therapies”
Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals
“The Baylor research provides a compelling scientific rationale for evaluating IGF-1 therapy for use with this condition. With an IND now submitted, we are excited to help translate this research into meaningful clinical advancement.”
John W. Swann, Distinguished Emeritus Professor of Pediatrics and Neuroscience at Baylor College of Medicine
“The planned clinical trial is also warranted because studies of spasms patients with structural brain abnormalities indicate that IGF-1 levels are reduced in their brains. Consequently, we hope that mecasermin/IGF-1 will serve as a replacement therapy to restore normal brain activity.”
Beth Dean, CEO of CURE Epilepsy
“CURE Epilepsy is thrilled to see this long-standing line of research from Dr. Swann’s lab move into human clinical trials. Dr. Swann was part of our Infantile Spasms Initiative, which began in 2012, and he and his collaborators have continued to fight to move their basic science discoveries toward clinical relevance for patients and families. Pediatric refractory epileptic spasms are catastrophic; these children urgently need new and better options, and we are grateful to Eton Pharmaceuticals for sponsoring this important next step towards a potential new treatment.”
* ET-900 targets a potential new indication for mecasermin, the active ingredient in Eton’s INCRELEX(®) * Eton has licensed patent rights from Baylor College of Medicine covering the use of insulin-like growth factor1 (IGF-1) for infantile and epileptic spasms * Research conducted at Baylor College of Medicine and Texas Children’s Hospital and funded by CURE Epilepsy and NIH, showed IGF-1 therapy led to reduction in spasms in the majority of treated animals * An Investigational New Drug application (IND) has been submitted to the United States Food and Drug Administration (FDA) for an investigator-sponsored Phase 2 study to evaluate mecasermin/IGF-1 in children with refractory epileptic spasms, with first patient dosing planned in Q1 2027 * Eton retains commercial rights to ET-900 and the product candidate would align with the Company’s planned entry into the pediatric neurology therapeutic area DEER PARK, Ill., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced ET-900, a new development program evaluating mecasermin injection for the treatment of infantile and epileptic spasms. Mecasermin is a recombinant form of IGF-1 and the active ingredient in INCRELEX, which Eton markets in the United States. The Company has entered into a license agreement with Baylor College of Medicine covering patent rights related to the use of IGF-1 for the treatment of spasms.
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