Marinus Pharmaceuticals, Inc. announced completion of enrollment in the global Phase 3 TrustTSC trial evaluating oral ganaxolone for the treatment of seizures associated with Tuberous sclerosis complex (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 U.S. Food and Drug Administration in April 2025 with priority review requested.

Marinus also announced that the United States Patent and Trademark Office (USPTO) has granted a new method of use patent (U.S. Patent No. 11,980,625) for ganaxolone in the treatment of TSC, expiring in 2040. TrustTSC (NCT05323734) is a global Phase 3 randomized, double-blind, placebo-controlled clinical trial of adverse adverse events in children and adults with TSC-related epilepsy.

The Company first introduced FDA-approved prescription medication ZTALMY (ganaxolone) oral suspension CV in the U.S. in 2022 and continues to invest in the potential of ganaxolone in IV and oral formulations to maximize therapeutic reach for adult and pediatric patients in acute and chronic care settings. Examples of forward-looking statements contained in this press release include, among others, statements regarding statements regarding expected clinical development plans, enrollment in clinical trials, regulatory communications and submissions for ganaxolone, and the timing thereof; expected data readouts; expectations and beliefs regarding the FDA and EMA with respect to product candidates; expectations regarding continued investment in IV and oral formulations of ganaxolone; and other statements regarding the company's future operations, financial performance, financial position, prospects, objectives and other future event.