GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder
Shots:
- The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations
- Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk. maintenance period, plus clinicians & caregivers reported overall clinical improvement per CGI-C, CaGI-C, & ABC-C
- The P-III trial for radiprodil in GRIN-related neurodevelopmental disorder is expected to initiate in mid-2025 to evaluate its effects on seizures, behavioral abnormalities & functional outcomes, using $200M capital commitment from Blackstone Life Sciences
Ref: Prnewswire | Image: GRIN Therapeutic
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