logo-loader

Marinus completes patient recruitment in late stage trial of ganaxolone in focal onset seizures

Published: 08:25 16 Dec 2015 EST

rsz_shutterstock_84300316
Marinus develops therapeutics to treat epilepsy and neuropsychiatric disorders.

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.

Shares closed up 2.9% at $6.12 on Tuesday, trimming this year's fall to 44%.

Rush Rare Metals Advances Two Key Projects: Uranium in Wyoming and Niobium...

Rush Rare Metals CEO Peter Smith joined Steve Darling from Proactive to share news about the mineral exploration company's focus on its Boxi Property in Quebec and the Copper Mountain Project in Wyoming. The company recently announced the staking of the Knob claims in Wyoming, comprising 52...

24 minutes ago