Marinus says will stop developing adult focal onset seizure drug as Phase III trials fail; shares plunge

pharmafile | June 14, 2016 | News story | Manufacturing and Production, Research and Development Drug-Resistant Epilepsy, Marinus Pharmaceuticals, drug trial, ganaxolone 

Shares in Marinus Pharmaceuticals (Nasdaq: MRNS) more than halved in value Monday after the company said it plans to stop development of its adult focal onset seizure drug after ganaxolone failed in late stage trials.

Christopher Cashman, chief executive of Marinus Pharmaceuticals, said: “We are disappointed with the outcome of this study, and the unfortunate impact on the epilepsy community and particularly the patients suffering from drug-resistant focal onset seizures who are benefiting from ganaxolone treatment. We remain confident in the safety profile of ganaxolone and its ability to effectively reduce seizures in targeted patient populations. We are committed to building our ganaxolone franchise and are confident in the potential of ganaxolone in the treatment of status epilepticus and pediatric orphan seizure and behavior disorders. We will provide an update in the upcoming weeks on our clinical programs in these indications.”

The study was conducted with 359 patients with drug-resistant epilepsy, the company said in a statement.

Albena Patroneva, chief medical officer of Marinus Pharmaceuticals, said: “The design, conduct, patient demographics and median separation versus placebo were similar to our positive Phase II trial and other studies conducted with recently approved antiepileptic drugs. While we did not see the incremental efficacy at a higher dose that we were hoping to achieve, ganaxolone continued to display a good safety profile — a key attribute for the product’s future development. We will leverage the findings from this study in the conduct of our ongoing and future studies in pediatric orphan indications and status epilepticus.”

Epileptic seizures require chronic treatment, often over a lifetime. Available antiepileptic drugs (AEDs) are efficacious for many patients, but chronic treatment is complicated by side effects, including cardiovascular risks, liver enzyme induction, kidney stones, behavioral changes, sedation and adverse effects on cognitive function, drug tolerance, and reproductive risk.

According to Decision Resources, in 2014 about five million people were under treatment for epilepsy in the US, Europe and Japan.

Anjali Shukla

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