{"id":1015992,"date":"2026-11-02T07:14:32","date_gmt":"2026-11-02T12:14:32","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms\/"},"modified":"2026-11-02T07:14:32","modified_gmt":"2026-11-02T12:14:32","slug":"eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms\/","title":{"rendered":"Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin\/IGF-1 for Treatment of Infantile and Epileptic Spasms"},"content":{"rendered":"<div class=\"mw_release\">\n<ul type=\"disc\">\n<li style=\"margin-bottom:8pt\">ET-900 targets a potential new indication for mecasermin, the active ingredient in Eton\u2019s INCRELEX<sup>\u00ae<\/sup><\/li>\n<li style=\"margin-bottom:8pt\">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<\/li>\n<li style=\"margin-bottom:8pt\">Research conducted at Baylor College of Medicine and Texas Children\u2019s Hospital and funded by CURE Epilepsy and NIH, showed IGF-1 therapy led to reduction in spasms in the majority of treated animals<\/li>\n<li style=\"margin-bottom:8pt\">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<\/li>\n<li style=\"margin-bottom:8pt\">Eton retains commercial rights to ET-900 and the product candidate would align with the Company\u2019s planned entry into the pediatric neurology therapeutic area\n<\/li>\n<\/ul>\n<p>DEER PARK, Ill., Nov.  02, 2026  (GLOBE NEWSWIRE) &#8212; Eton Pharmaceuticals, Inc. (\u201cEton\u201d or the \u201cCompany\u201d) (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.<\/p>\n<p>\u201cThese 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,\u201d said Sean Brynjelsen, Chief Executive Officer of Eton Pharmaceuticals. \u201cThe 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.\u201d<\/p>\n<p>Research led by Dr. John W. Swann, Ph.D., Distinguished Emeritus Professor of Pediatrics and Neuroscience at Baylor College of Medicine, and funded by CURE Epilepsy has identified impaired IGF-1 signaling as a potential contributor to the development of epileptic spasms. In an animal model, treatment with recombinant human IGF-1 reduced daily spasm counts by approximately 50% and eliminated spasms in 20% of treated animals. These preclinical findings provide a scientific rationale for evaluating mecasermin in children with refractory epileptic spasms.<\/p>\n<p>\u201cThe 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,\u201d added Dr. Swann.\u00a0\u00a0<\/p>\n<p>\u201cCURE Epilepsy is thrilled to see this long-standing line of research from Dr. Swann\u2019s 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,\u201d said Beth Dean, CEO of CURE Epilepsy.<\/p>\n<p>A research IND has been submitted for an investigator-sponsored Phase 2 to evaluate mecasermin for efficacy, safety, and tolerability in children with refractory epileptic spasms. The study will be sponsored by the University of Chicago and is expected to enroll up to 20 patients ages 2\u201318 years across three sites, University of Chicago, Baylor College of Medicine, and UCLA, whose spasms have not responded to, or who have been unable to tolerate, hormonal therapy and vigabatrin. Patients will receive twice-daily subcutaneous injections during an initial three- to five-week treatment period. An additional treatment course may be available to certain patients based on clinical response. The study will assess spasm resolution, changes in daily spasm frequency, and resolution or improvement of associated electroencephalogram (\u201cEEG\u201d) abnormalities. Additional assessments will evaluate safety, tolerability, and adaptive functioning. Mecasermin is not FDA-approved for the treatment of infantile or epileptic spasms, and its safety and efficacy for these uses have not been established. Initial enrollment and dosing are targeted for the first quarter of 2027.<\/p>\n<p>\n        <strong>About Infantile and Epileptic Spasms<\/strong>\n      <\/p>\n<p>Infantile epileptic spasms syndrome is a rare, severe form of epilepsy that typically begins between the ages of 1 and 24 months. According to the American Academy of Pediatrics, approximately 2,500 children are diagnosed with infantile spasms in the United States each year. When spasms persist beyond the age of 2 they are referred to as epileptic spasms.<\/p>\n<p>These seizures, known as epileptic spasms, frequently occur in clusters and may be accompanied by hypsarhythmia, a highly abnormal pattern of brain activity detected on an EEG. Spasms can persist beyond age two into later childhood. Prompt diagnosis and treatment are critical because persistent spasms may adversely affect neurological development.<\/p>\n<p>Treatment resistance remains a significant challenge. A peer-reviewed study published in Epilepsy &amp; Behavior reports that seizures in approximately half of children with infantile spasms fail to improve with initial treatment attempts. Current therapies are not effective for every patient and can be associated with significant limitations. For children whose spasms persist despite treatment, these challenges underscore an urgent need for new therapeutic options.<\/p>\n<p>\n        <strong>About<\/strong><br \/>\n        <strong>\u00a0<\/strong><br \/>\n        <strong>Eton <\/strong><br \/>\n        <strong>Pharmaceuticals<\/strong>\n      <\/p>\n<p>Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has twelve rare disease products: KHINDIVI<sup>\u00ae<\/sup> (hydrocortisone), INCRELEX<sup>\u00ae<\/sup> (mecasermin), ALKINDI SPRINKLE<sup>\u00ae<\/sup> (hydrocortisone), DESMODA<sup>\u2122<\/sup> (desmopressin acetate), GALZIN<sup>\u00ae<\/sup> (zinc acetate), HEMANGEOL<sup>\u00ae<\/sup> (propranolol hydrochloride), PKU GOLIKE<sup>\u00ae<\/sup>, IMPAVIDO<sup>\u00ae<\/sup> (miltefosine), LIBERVANT<sup>\u00ae<\/sup> (diazepam), Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has six additional product candidates in late-stage development: AMGLIDIA<sup>\u00ae<\/sup> (glyburide oral suspension), ASN-001, ET-700, ET-800, ET-900, and ZENEO<sup>\u00ae<\/sup> hydrocortisone autoinjector. For more information, please visit our website at <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=l7tbNQJ_3ahLJT0R0yuhTKR1ffvJylh-2xcuGdQx3YLWFkOVwsoPtmg2iVzsUhZFV0nSZ2R9FDqOBVb96Hf_pfxruIe9oO0X-sh8ubZPX7s=\" rel=\"nofollow\" target=\"_blank\">www.etonpharma.com<\/a>.<\/p>\n<p>\n        <strong>Investor Relations:<\/strong><br \/>\n        <br \/>Lisa M. Wilson, In-Site Communications, Inc.<br \/>T: 212-452-2793<br \/>E: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=LGED5kcGTMs_j0KCEAxlj6mgLSup9lzanMA3ksDiFhcJxGGEk3S2Y152VCA52SIZerBcwJC8frIM0cNaJR3AlMlCfEIivNFubJFJPHy469E=\" rel=\"nofollow\" target=\"_blank\">lwilson@insitecony.com<\/a><\/p>\n<p>      <img decoding=\"async\" alt=\"\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg2NzYzNSM3OTI3ODk4IzIxMjI5ODQ=\" \/><br \/>\n      <br \/>\n      <img decoding=\"async\" alt=\"\" src=\"https:\/\/ml.globenewswire.com\/media\/NDg1OWFlOWQtZDYwZC00NGM5LTgxYjMtOTc0ZWM1ODAwZmIzLTExMzQ1NTUtMjAyNi0xMS0wMi1lbg==\/tiny\/Eton-Pharmaceuticals.png\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>ET-900 targets a potential new indication for mecasermin, the active ingredient in Eton\u2019s INCRELEX\u00ae 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\u2019s 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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin\/IGF-1 for Treatment of Infantile and Epileptic Spasms&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1015992","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin\/IGF-1 for Treatment of Infantile and Epileptic Spasms - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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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 &hellip; Continue reading &quot;Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin\/IGF-1 for Treatment of Infantile and Epileptic Spasms&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-11-02T12:14:32+00:00\" \/>\n<meta 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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\u2019s 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 &hellip; Continue reading \"Eton Pharmaceuticals Announces Licensing and Initiation of ET-900 Program Evaluating Mecasermin\/IGF-1 for Treatment of Infantile and Epileptic Spasms\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/eton-pharmaceuticals-announces-licensing-and-initiation-of-et-900-program-evaluating-mecasermin-igf-1-for-treatment-of-infantile-and-epileptic-spasms\/","og_site_name":"Market Newsdesk","article_published_time":"2026-11-02T12:14:32+00:00","og_image":[{"url":"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=OTg2NzYzNSM3OTI3ODk4IzIxMjI5ODQ=","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"5 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