Investors & Media
News
Sage Therapeutics Announces Initiation of Phase 1 Development and First Dosing of SAGE-718
Lead compound from novel NMDA modulator product development platform
Top-line results from single ascending dose trial expected in 2H 2017
"Advancing SAGE-718 into Phase 1 clinical development represents a
significant achievement in broadening our clinical pipeline beyond GABA,
with a new product development platform focused on a novel mechanism to
modulate the NMDA receptor system," said
SAGE-718 is a novel, oral, first-in-class oxysterol-based positive allosteric modulator (PAM) of the N-methyl-D-aspartate (NMDA) receptor, acting in a similar manner as 24(S)-hydroxycholesterol (cerebrosterol), an endogenous modulator of NMDA receptor function. Positive modulation of NMDA receptors may have potential in the treatment of a range of neurological disorders associated with a variety of cognitive, neurological and behavioral symptoms.
SAGE-718 may also have potential in the treatment of CNS disorders
associated with a high prevalence of anti-NMDA antibodies or reduced
levels of plasma cerebrosterol. In preclinical studies, SAGE-718
improved social behavior in an animal model of NMDA hypofunction, and
ameliorated both behavioral and electrophysiological deficits in a model
of compromised cholesterol regulation. The effects of NMDA PAMs on
cerebrosterol deficit preclinical models were presented at the 2016
annual meetings of the
"SAGE-718 is our lead NMDA PAM candidate, and was selected from over 800
novel compounds in our NMDA modulator library. SAGE-718 is designed for
once-daily dosing, good oral bioavailability, and high selectivity for
the NMDA receptors," said
The Phase 1 single ascending dose study of SAGE-718 is a double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of SAGE-718 administered orally in healthy adult volunteers.
About SAGE-718 and NMDA Receptors
SAGE-718 is a novel, oral, first-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors. SAGE-718 is the lead compound from Sage's NMDA modulator platform.
NMDA receptors are glutamate-gated cation channels that play a critical role in the health and regulation of neurons, and are involved in learning, memory and neuroplasticity. Positive modulation of NMDA receptors may have potential in the treatment of conditions associated with NMDA hypofunction and disorders associated with a high prevalence of anti-NMDA antibodies, such as anti-NMDA receptor encephalitis, as well as in disorders associated with reductions in plasma cerebrosterol, such as Huntington's disease and Alzheimer's disease.
About
Forward-Looking Statements
Various statements in this release concerning SAGE's future
expectations, plans and prospects, including without limitation, our
expectations regarding development of SAGE-718 and the potential of
SAGE-718 and positive modulation of NMDA receptors in the treatment of
various CNS disorders; the expected timing of availability of data from
the Phase 1 study of SAGE-718; and the potential for our other product
candidates, constitute forward-looking statements for the purposes of
the safe harbor provisions under the Private Securities Litigation
Reform Act of 1995. These forward-looking statements are neither
promises nor guarantees of future performance, and are subject to a
variety of risks and uncertainties, many of which are beyond our
control, which could cause actual results to differ materially from
those contemplated in these forward-looking statements, including the
risks that: we may encounter unexpected adverse events in healthy
volunteers that causes us to discontinue further development of
SAGE-718; we may not be able to successfully demonstrate the safety and
efficacy of SAGE-718, or any of our other product candidates, at each
stage of development; success in pre-clinical studies or in early stage
clinical trials may not be repeated or observed in ongoing or future
studies involving the same compound or other product candidates, and
ongoing or future pre-clinical and clinical results may not support
further development of product candidates or a class of product
candidates or be sufficient to gain regulatory approval to market any
product; decisions or actions of regulatory agencies may negatively
affect the initiation, timing and progress of clinical trials, and our
ability to proceed with further clinical studies of a product candidate
or to obtain marketing approval; we may not be able to obtain or
maintain adequate intellectual property protection and other forms of
marketing and data exclusivity for our product candidates; and we
may encounter technical and other unexpected hurdles in the manufacture
and development of our products, as well as those risks more fully
discussed in the section entitled "Risk Factors" in our most recent
annual report on Form 10-K, as well as discussions of potential risks,
uncertainties, and other important factors in our subsequent filings
with the
View source version on businesswire.com: http://www.businesswire.com/news/home/20170427005598/en/
Investors:
paul.cox@sagerx.com
or
Media:
maureen.suda@sagerx.com
Source:
News Provided by Acquire Media