CAMBRIDGE, Mass. (THESTREET) -- Certain patients have epilepsy so severe that current drugs can't stop the brain from suffering seizures. The only way to treat these patients is to place them in a medically-induced coma and hope the brain's electrical signals reset over time. In extreme cases, patients can't be weaned from a coma without the seizures returning.
On Monday, Sage Therapeutics (SAGE) reported results from a small clinical trial in which an experimental drug known as SAGE-547 helped about three-quarters of patients with the severest and most treatment-resistant epilepsy to emerge from medically-induced comas.
Based on this promising data, Sage intends to work with the U.S. Food and Drug Administration on a design for a phase III study, which could start in the first half of next year. The company's goal is to develop the first effective therapy for the most difficult to treat epilepsy patients who suffer from what is known as super-refractory status epilepticus.
In the phase II study, eight of 11 patients with super-refractory status epilepticus (SRSE) were successfully weaned off anesthesia while SAGE-547 was being administered. The eight patients were then weaned successfully off SAGE-547 without a recurrence of their SRSE, which would have necessitated inducing another medical coma.
The 73% response rate to SAGE-547 was accomplished with relatively few drug-related serious adverse events, Sage reported.
Before Sage went public in July, earlier results from this same study were reported, in which four of four SRSE patients responded to treatment with SAGE-547. Sage continues to enroll SRSE patients, including children, into this phase II study, which will also investigate higher doses of the drug.
Sage estimates there are approximately 25,00O patients in the U.S. with SRSE. The company has plans to study the drug further in patients with less severe forms of epilepsy.
SG-547 is a proprietary formulation of the neurologic steroid allopregnanolone. The drug works by binding to receptors in the brain differently than currently approved anti-seizure medications. Sage went public in July at $18 per share. The stock closed Friday at $38.72.