Marinus Pharmaceuticals (NASDAQ:MRNS), a clinical stage biopharmaceutical company, completed patient recruitment for the late stage clinical trial of ganaxolone in adults with drug-resistant focal onset seizures.
Sites participating in this global study have completed screening patients, the Randor, Pennsylvannia-based company said in a statement on Wednesday.
After establishing eight weeks of baseline seizure frequency, patients randomized in the study undergo a two-week titration period followed by a twelve-week maintenance period.
Marinus, which develops therapeutics to treat epilepsy and neuropsychiatric disorders, anticipates announcing top-line results from the study in mid-2016.
“Completing patient recruitment in our Phase 3 trial is an important milestone in the clinical development of our ganaxolone program, as well as for the epilepsy community," CEO Christopher Cashman said in the statement.
"This Phase 3 study is designed similarly to our Phase 2 study that was conducted in patients experiencing drug-resistant seizures for more than 25 years, and where ganaxolone met the primary endpoint and was safe and well-tolerated."
Cashman said that a responder analysis showed that 40% of the ganaxolone-treated patients achieved at least 30% reduction in mean weekly seizure frequency.
The global, randomized, placebo-controlled Phase 3 study is designed to evaluate the effectiveness and safety of ganaxolone as an adjunctive therapy in adults with drug-resistant focal onset seizures.
Around 350 patients will be randomized to receive either 1,800 mg/day of ganaxolone or placebo for 12 weeks.
The primary endpoint of the study is percent change in seizure frequency per 28 days relative to the baseline.
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