Marinus Pharmaceuticals announced top-line results from the Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset seizures.
The Phase 3 study was a multi-national, double-blind, randomized, placebo-controlled trial evaluating ganaxolone in 359 adult patients with drug-resistant focal onset seizures. Patients received either ganaxolone 1,800mg once daily or placebo.
The study failed to meet the primary endpoint of percent change in the 28-day seizure frequency from baseline (P=0.1537). Data showed that patients treated with ganaxolone had a median percent reduction of focal onset seizures of 21.28% vs. 10.25% in the placebo group during the titration and the 12-week treatment period. Ganaxolone was found to be generally safe and well tolerated in this study, showing a consistent safety profile as previously conducted studies. The most common adverse events (>5%) reported at greater rates than placebo were somnolence (23.5% vs. 4.5%), dizziness (19.6% vs. 4.5%) and fatigue (11.7% vs. 6.8%).
Marinus plans to discontinue its clinical program for ganaxolone in adult focal onset seizures and focus its development in other potential indications, including status epilepticus and pediatric orphan seizure disorders.
Ganaxolone is a CNS-selective GABAA modulator under development in an injectable, capsule and liquid dosage forms.
For more information visit Marinuspharma.com.