Marinus notes TrustTSC trial misses primary endpoint, to evaluate alternatives

Marinus Pharmaceuticals (MRNS) announced that the Phase 3 TrustTSC trial evaluating oral ganaxolone for the treatment of seizures associated with tuberous sclerosis complex, or TSC, in children and adults did not meet the primary endpoint of percent change in 28-day TSC-associated seizure frequency. While reductions in seizure frequency favored the ganaxolone arm, the primary endpoint did not achieve statistical significance. Topline data demonstrated that: The trial did not achieve statistical significance on its primary endpoint of percent reduction in 28-day frequency of TSC-associated seizures: median reduction was 19.7% for ganaxolone compared with 10.2% for placebo. Ganaxolone was generally well-tolerated with a safety profile consistent with previous clinical trials. The most frequent adverse event was somnolence: 28.1% for ganaxolone compared with 16.9% for placebo. Marinus will continue to support and invest in the commercial growth of Ztalmy oral suspension CV, which is FDA-approved for the treatment of seizures associated with CDKL5 deficiency disorder in patients two years of age and older, where more than 200 patients are receiving treatment. As a result of the TrustTSC outcome, Marinus is discontinuing further ganaxolone clinical development and is taking additional steps to reduce costs, including a reduction in its workforce. The company has also commenced a process to explore strategic alternatives with the goal of maximizing value for its stockholders.