Eton Pharmaceuticals launches ET‑900 program and files IND for Phase 2 infantile and epileptic spasm trial
+1 new source since this summary was written
Eton Pharmaceuticals announced ET‑900, a new development program evaluating mecasermin (the active ingredient in INCRELEX®) for infantile and epileptic spasms. The company has licensed patent rights from Baylor College of Medicine for the IGF‑1 indication and submitted an IND to the FDA for an investigator‑sponsored Phase 2 study. The trial, to be run by the University of Chicago, will enroll up to 20 children and is slated to begin dosing in the first quarter of 2027.
Why it matters
The IND filing moves ET‑900 into human testing, creating a near‑term clinical milestone that could unlock future pediatric neurology revenue if the trial shows safety and efficacy. The program also expands Eton’s pipeline beyond its existing rare‑disease products.
Key facts
- 1Eton licensed patent rights from Baylor College of Medicine covering the use of insulin‑like growth factor‑1 for infantile and epileptic spasms. stocktitan.net
- 2An Investigational New Drug application was submitted to the FDA for a Phase 2 study of mecasermin/IGF‑1 in children with refractory epileptic spasms. stocktitan.net
- 3The Phase 2 study is planned to enroll up to 20 patients ages 2–18 across three sites and to begin first patient dosing in Q1 2027. stocktitan.net
- 4Mecasermin is the active ingredient in Eton’s marketed product INCRELEX® and is not FDA‑approved for the spasm indication. stocktitan.net
- 5Eton retains commercial rights to the ET‑900 program. stocktitan.net
- 6ETON shares rose 1.57% to $53.00 in pre‑market trading following the announcement. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.