CAMBRIDGE, Mass. & SALZBURG, Austria--(BUSINESS WIRE)--SAGE Therapeutics, a neuroscience product focused company creating novel medicines to treat important central nervous system (CNS) disorders, today announced that SGE-102, the company’s proprietary positive GABAA receptor allosteric modulator for status epilepticus (SE), will be highlighted at The 4th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures, being held April 4-6, 2013 in Salzburg, Austria. Data from the company’s preclinical SGE-102 program, a case study on the first-in-man treatment of intravenous (IV) SGE-102 in refractory SE and an overview of SAGE’s planned Phase 1/2 clinical trial of SGE-102 in patients with refractory SE will all be presented at the conference. SE is an acute, life-threatening form of epilepsy or seizures in which a patient experiences continuous or rapidly repeating seizures and occurs in approximately 200,000 U.S. patients each year.
“Since the company’s launch in late 2011, SAGE has made rapid and efficient progress advancing our pipeline, and we expect to enter human clinical trials with our breakthrough SE program later this year,” said Kevin Starr, interim chief executive officer at SAGE Therapeutics. “We are pleased to share the successful outcome of the first-in-man experience treating a refractory SE patient with SGE-102 with clinicians in the medical community. We believe that SGE-102 could be a promising treatment for this orphan indication, with the potential of making a dramatic impact on patients’ outcomes.”
Approximately one-third of patients with SE do not respond to first- and second-line treatments and are moved to an ICU setting with limited treatment options. Early preclinical data demonstrate that SGE-102 may be more effective in treating SE than current standard-of-care benzodiazepines due to its unique mechanism of positively modulating key GABAA receptor subtypes. In addition, SAGE is currently developing advanced, next-generation compounds of novel GABAA positive allosteric modulators (PAMs) for the treatment of SE and other forms of seizure and epilepsy, using its Positive and Negative Allosteric Modulator (PANAM) platform.
“Under a compassionate use exemption, we have successfully treated a refractory SE patient with SGE-102,” said Andrew Cole, M.D., director of The MGH Epilepsy service at Massachusetts General Hospital and professor of neurology at Harvard Medical School. “Preclinical research and this first-in-man case study of SGE-102 in refractory SE suggest that SGE-102 may provide an effective treatment for these patients who have few or no options and provide a compelling rationale for further evaluation of the compound in clinical trials.”
In a poster presented at the meeting, Dr. Cole will highlight early clinical findings of SGE-102 in a 23-year-old patient with refractory SE. The patient had been treated with numerous anticonvulsants and was placed into a pentobarbital-induced coma to suppress constant and uncontrollable seizures. After more than 90 days and eight unsuccessful attempts to wean the patient from pentobarbital without a return of seizure activity, SGE-102 was administered over a 5-day period during which the patient emerged from the pentobarbital coma without recurrence of seizures. The patient has continued to recover, has left the hospital and is currently seizure-free. Dr. Cole will also make an oral presentation at the meeting highlighting the trial design for a Phase 1/2 study of SGE-102 in refractory SE that SAGE expects to initiate later this year.
Michael Rogawski, M.D., Ph.D., professor of neurology at the University of California, Davis and member of SAGE’s scientific advisory board, will also make an oral presentation highlighting preclinical data supporting the use of neuroactive steroids in SE. SGE-102 preclinical data will be featured in the presentation, including robust findings demonstrating significantly increased efficacy over current standard-of-care benzodiazepine treatments.
About SAGE Therapeutics
SAGE Therapeutics is a neuroscience product focused company developing breakthrough medicines to treat CNS disorders with tremendous unmet need including status epilepticus, anesthesia, Fragile X and traumatic brain injury. The company’s proprietary Positive and Negative Allosteric Modulator (PANAM) Platform leverages extensive chemistry expertise to enable the safe and efficacious allosteric modulation of GABAA or NMDA receptors to restore the balance of activity that is disrupted in a variety of CNS disorders. As a result, SAGE has built a robust product pipeline initially focused on acute and orphan CNS indications with clinically validated targets, accelerated development timelines and a wide range of additional applications. SAGE Therapeutics is a private company launched in 2011 by a proven team of R&D leaders, renowned CNS experts and Third Rock Ventures. For more information, please visit www.sagerx.com.