An In-Depth Look at the Phase 1/2 SRSE Trial Data and Patient Characteristics
Health Economic Burden of Treatment Defined for SRSE
Data on Exploratory Results in Essential Tremor
CAMBRIDGE, Mass., March 03, 2016 (GLOBE NEWSWIRE) -- Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced five upcoming data presentations at the. 68th American Academy of Neurology (AAN) Annual Meeting, taking place April 15-21, 2016 in Vancouver, BC.
“This collection of abstracts highlights our CNS leadership and the unique and disruptive approach that Sage is pursuing in drug development, where we lead with human data and utilize clinical trials to inform our understanding of the biology of the disease as well as the activity of the investigational compound,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. “At AAN, we will feature new scientific data and analyses from our lead compound SAGE-547 in two indications with significant unmet medical need. This will include an in depth review of response rates from the first clinical trial in super refractory status epilepticus (SRSE) and we will present data in our exploratory trial in essential tremor.”
The schedule for the presentations is as follows:
Date: Sunday, April 17, 2016
Platform Presentation Time: 1:30 p.m. – 1:45 p.m. PST
Location: Vancouver Convention Center
Title: 547-SSE-201 for Super-Refractory Status Epilepticus: Response and Relationship to Underlying Patient Characteristics
Date: Tuesday, April 19, 2016
Poster Presentation Time: 8:30 a.m. – 7:00 p.m. PST
Location: Vancouver Convention Center, East Exhibition Hall BC
Title: Quantitative Burst Suppression as a Biomarker in the Phase 2 Trial of SAGE-547: Lessons Learned for the First International Phase 3, Randomized, Controlled Trial for Super-Refractory Status Epilepticus (The STATUS Trial)
Date: Tuesday, April 19, 2016
Poster Presentation Time: 8:30 a.m. – 7:00 p.m. PST
Location: Vancouver Convention Center, East Exhibition Hall BC
Title: Phase 2 Data Suggest Heterogeneity of Presentation and Comorbidity Burden Do Not Impact Activity of SAGE-547 in Patients with Super-Refractory Status Epilepticus
Date: Tuesday, April 19, 2016
Poster Presentation Time: 8:30 a.m. – 7:00 p.m. PST
Location: Vancouver Convention Center, East Exhibition Hall BC
Title: Defining the Health Economic Burden of Treatment for Super-Refractory Status Epilepticus Patients
Date: Tuesday, April 19, 2016
Poster Presentation Time: 8:30 a.m. – 7:00 p.m. PST
Location: Vancouver Convention Center, East Exhibition Hall BC
Title: Exploratory Trial Results for SAGE-547 in Essential Tremor
About SAGE-547
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. SAGE-547 is an intravenous agent in Phase 3 clinical development as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE). SAGE-547 has been granted both Fast Track and orphan drug designations by the U.S. Food and Drug Administration (FDA) for the treatment of SRSE. SAGE-547 is being evaluated as a treatment for patients with SRSE in the global Phase 3 STATUS Trial. For more information about the STATUS Trial, please visit www.statustrial.com.
About Super-Refractory Status Epilepticus
Status epilepticus (SE) is an acute medical emergency of persistent, unremitting seizure lasting greater than five minutes. An SE patient is first treated with benzodiazepines, and if no response, is then treated with other, second-line, anti-seizure drugs. If the seizure persists after the second-line therapy, the patient is diagnosed as having refractory SE (RSE), admitted to the ICU and placed into a medically induced coma. Physicians typically use anesthetic agents to induce the coma, along with antiepileptic drugs in an attempt to stop the ongoing seizure, in RSE patients. After a period of 24 hours, an attempt is made to wean the patient from the anesthetic agents to evaluate whether or not the seizure condition has resolved. Unfortunately, not all patients respond to weaning attempts, in which case the patient must be maintained in the medically induced coma. At this point, the patient is diagnosed as having SRSE. Currently, there are no therapies specifically approved for SRSE.
About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage's lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder. Sage is developing its next generation modulators, including SAGE-217, SAGE-689 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.