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SAGE Therapeutics Receives Fast Track Designation for Lead Compound SAGE-547 to Treat Status Epilepticus
Designation Underscores Unmet Medical Need for Life-Threatening Seizure Condition
"The fast track designation for SAGE-547 recognizes the significant
unmet need that exists in the treatment of super-refractory status
epilepticus," said
Fast track designation is granted by the
About SAGE-547
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. GABAA receptors are widely regarded as validated drug targets for a variety of CNS disorders, with decades of research and multiple approved drugs targeting these receptor systems. SAGE-547 is an intravenous agent in Phase 1/2 clinical development as an adjunctive therapy, a therapy combined with current therapeutic approaches, for the treatment of SRSE.
About Status Epilepticus (SE)
SE is a life-threatening seizure condition that occurs in approximately 150,000 people each year in the U.S., of which 30,000 SE patients die.1 We estimate that there are 35,000 patients with SE in the U.S. that are hospitalized in the intensive care unit (ICU) each year. 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. Currently, there are no therapies that have been specifically approved for RSE; however, physicians typically use anesthetic agents to induce the coma and stop the seizure immediately. 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
Forward-Looking Statements
Various statements in this release concerning SAGE's future
expectations, plans and prospects, including without limitation, SAGE's
expectations regarding SAGE-547 as a treatment for SRSE, the expected
development pathway for its other drug candidates and its expectations
with respect to the timing and success of its clinical trials,
constitute forward-looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform Act of
1995. Actual results may differ materially from those indicated by these
forward-looking statements as a result of various important factors,
including, without limitation, SAGE's ability to successfully
demonstrate the efficacy and safety of its drug candidates, the
pre-clinical and clinical results for its product candidates, which may
not support further development of product candidates, actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials, obtaining, maintaining and protecting
intellectual property, SAGE's ability to enforce its patents against
infringers and defend its patent portfolio against challenges from third
parties, competition from others developing products for similar uses,
SAGE's ability to manage operating expenses, SAGE's ability to obtain
additional funding to support its business activities and establish and
maintain strategic business alliances and new business initiatives,
SAGE's dependence on third parties for development, manufacture,
marketing, sales and distribution of products, the outcome of
litigation, and unexpected expenditures, as well as those risks more
fully discussed in the section entitled "Risk Factors" in the final
prospectus related to SAGE's initial public offering filed with the
1 DeLorenzo, Robert J., Pellock, John M.,
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Source: SAGE Therapeutics
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