Marinus Pharmaceuticals, Inc., Completes Two Phase 2 Milestones for Ganaxolone in Epilepsy.
RANFORD, Conn., Oct. 7 /PRNewswire/ -- Marinus Pharmaceuticals, a developer of specialty therapeutics to treat neurological and psychiatric disorders, today announced that it has completed its Phase 2 clinical trial of ganaxolone for the treatment of infantile spasms (also called West syndrome) and that the final patient has completed enrollment for its Phase 2 clinical trial of ganaxolone for the treatment of adult partial complex seizures.
"Completion of the infantile spasms study and the completion of recruitment in the adult partial seizure trial are significant milestones for the ganaxolone program," said John Krayacich, CEO of Marinus. "We are anxious to review the unblinded data in the infantile spasms study and hope to present the data to the medical community early in 2009. We anticipate the data in the adult study to be available in the first half of 2009 and to present the data in the second half of 2009."
"We would like to thank the patients, parents, investigators, and Marinus colleagues who have made this program possible. We believe ganaxolone represents a potential important new therapy for the treatment of various forms of epilepsy." Krayacich continued.
Previous Phase 1 and proof of concept studies of ganaxolone have demonstrated safety and efficacy in refractive epilepsy. The ganaxolone program currently consists of four clinical studies, one infantile spasms and one adult partial seizure study as well as open label extensions for each study. Approximately 2.5 million Americans suffer from epilepsy.
Ganaxolone is a synthetic neurosteroid and is being investigated as a first in class drug for the treatment of epilepsy. Ganaxolone has been administered to more than 700 healthy adult volunteers and patients, 214 in Phase 1 studies, and approximately 500 patients in Phase 2 epilepsy and migraine studies. The epilepsy studies involved more than 100 patients and generated data supportive of ganaxolone's efficacy and safety in the treatment of both children and adults suffering from refractory epilepsy (patients who continue to have seizures even when taking multiple anticonvulsant drugs).