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Marinus Pharmaceuticals, Inc. Announces Positive Results of its Phase 2 Clinical Trial of Ganaxolone as Adjunctive Therapy in Adults With Partial Onset Seizures
Date:3/2/2009

es even while taking up to three antiepileptic drugs (AED). The trial enrolled 147 patients at 24 sites in the U.S. Patients were observed for baseline seizure activity for 8 weeks and were then randomized to receive either ganaxolone or placebo in addition to their existing stable AED regimen. Patients entering the trial were experiencing, on average, 8 to 11 seizures per month. The most common background AEDs in the trial were lamotrigine, levetiracetam, carbamazepine, and topiramate.

Patients randomized to the ganaxolone treatment arm were titrated over one to two weeks to a maintenance dose of 1,500 mg/day where they were maintained for an additional 8 weeks. Patients in the ganaxolone arm met the primary endpoint showing a statistically significant reduction of mean weekly seizure frequency vs. the placebo arm during the titration and maintenance period (P<0.0251). In addition, the patients in the ganaxolone arm also showed an improvement on percent reduction in seizure frequency vs. placebo (P<0.0144). Responder rates (patients with greater than 50 percent reduction in seizures) were numerically larger in the ganaxolone arm vs. placebo but did not reach statistical significance in this study (P<0.1926).

"It is encouraging to see these positive results for a novel compound such as ganaxolone," states Joyce Cramer, president of the Epilepsy Therapy Project. "Thirty percent of epilepsy patients still do not have their epilepsy controlled with current antiepileptic drugs. There is a clear need for new treatment options, especially drugs with new mechanisms of action to complement the currently available therapies."

Ganaxolone was generally well tolerated with the majority of patients able to escalate and maintain the 1500 mg/day dose. The discontinuation rates due to adverse events between placebo and ganaxolone arms were 6 percent and 7 percent, respectively. The most commonly reported adve
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SOURCE Marinus Pharmaceuticals, Inc.
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