Marinus Pharmaceuticals announced completion of enrollment in the global Phase 3 TrustTSC trial evaluating oral ganaxolone for the treatment of seizures associated with tuberous sclerosis complex, or TSC, in children and adults. Topline data from the TrustTSC trial is anticipated in the first half of the fourth quarter of 2024. Marinus is targeting submission of a supplemental New Drug Application to the FDA in April 2025 with priority review requested. Marinus also announced that the United States Patent and Trademark Office, or USPTO, has granted a new method of use patent for ganaxolone in the treatment of TSC, expiring in 2040. This is Marinus’ second method of use patent granted for ganaxolone in TSC.
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