Zinger Key Points
- While reductions in seizure frequency favored the ganaxolone arm, the primary endpoint did not achieve statistical significance.
- Marinus is discontinuing further ganaxolone clinical development and taking additional steps to reduce costs.
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On Thursday, Marinus Pharmaceuticals, Inc. MRNS stock plunged after the company revealed disappointing data from the Phase 3 TrustTSC trial of oral ganaxolone for seizures associated with tuberous sclerosis complex (TSC) in children and adults.
TSC is a rare genetic condition that mainly causes non-cancerous (benign) tumors to develop in different body parts.
Also Read: Marinus Pharmaceuticals Shares Mixed Results From IV Formulated Ganaxolone In Pretreated Seizure Patients.
“As the first controlled trial in TSC that allowed enrollment of patients taking a range of concomitant antiseizure medications, which included mTOR inhibitors and cannabidiol, these data represent a significant advancement in our understanding of the use of ganaxolone with other standard of care treatments,” said Scott Braunstein, Chairman and CEO of Marinus. “We are disappointed that the results of the TrustTSC trial are not likely to be sufficient for an sNDA filing.”
The 129-subject trial did not meet the primary endpoint of percent change in 28-day TSC-associated seizure frequency. Median reduction was 19.7% for ganaxolone compared with 10.2% for placebo (p=0.09).
While reductions in seizure frequency favored the ganaxolone arm, the primary endpoint did not achieve statistical significance.
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 (ganaxolone) oral suspension CV, which is FDA-approved for seizures associated with CDKL5 deficiency disorder in patients two years and older.
As a result of the TrustTSC outcome, Marinus is discontinuing further ganaxolone clinical development and taking additional steps to reduce costs, including reducing its workforce.
The company has also commenced a process to explore strategic alternatives and has engaged Barclays as an advisor to assist in reviewing its strategic alternatives.
Price Action: MRNS stock is down 82.80% at $0.29 at the last check Thursday.
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