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SAGE Therapeutics Presents New Preclinical Data on SAGE-217 at Eilat Conference on New Anti-Epileptic Drugs
Data Highlight Potential of SAGE-217 to Address Acute and Chronic Forms of Epilepsy and Seizure Disorders
"SAGE has developed a proprietary chemistry platform that we believe
allows us to efficiently identify and design selective neuroactive
molecules that impact two important, validated nervous system targets -
GABAA and NMDA receptors," said
SAGE-217 is a GABA-potentiating, second-generation neuroactive steroid that has demonstrated favorable CNS exposure (rodent brain to plasma ratio > 1.3-3.2), an attractive pharmacokinetic profile and the potential for IV, IM and oral administration. Preclinical data generated through in vitro electrophysiology studies utilizing mammalian cell lines showed that SAGE-217 was more efficacious in in vitro assays of GABAA modulation than either allopregnanolone or ganaxolone at both synaptic α1β2γ2-containing GABAA receptors and extra-synaptic α4β3δ-containing GABAA receptors. SAGE-217 also exhibited reduced off-target activities compared to the known first-generation analogs. In addition, in comparison to first-generation neurosteroids, SAGE-217 demonstrated efficacy at reduced levels of plasma and brain exposure in models of benzodiazepine-resistant seizure.
The company also presented data previously reported on SAGE-547, an allosteric modulator of GABAA receptors currently in clinical development for super-refractory status epilepticus (SRSE).
"We continue to make good progress on our portfolio of seizure product
candidates," said
About SAGE-217
SAGE-217 is a novel neuroactive steroid that acts as a positive allosteric modulator of synaptic and extra-synaptic GABAA receptor subtypes. Unlike many of the naturally occurring neuroactive steroids, SAGE-217 has a pharmacokinetic profile to potentially support once-daily oral dosing and a selectivity profile that minimizes potential off-target side effects. SAGE-217 is currently in preclinical development for a range of seizure conditions, including orphan genetic epilepsy disorders, such as Rett syndrome and Dravet syndrome.
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
Forward-Looking Statements
This release contains forward-looking statements and information,
including statements concerning SAGE's expectations regarding the
potential safety, pharmacological effect and efficacy of SAGE-547 and
SAGE-217, the expected development pathway for these and other product
candidates and its expectations with respect to the timing and success
of its clinical trials concerning. These and other statements concerning
SAGE's future expectations, plans and prospects constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of 1995
and other federal securities laws. In particular it should be noted that
the initial data reported from the ongoing Phase 1/2 clinical trial of
SAGE-547 are preliminary in nature and that the SAGE-547 clinical trial
has not been completed. The preliminary data may change as additional
data is released and such preliminary data may not be repeated or
observed in ongoing or future studies involving SAGE-547 or our other
product candidates. It should also be noted that the SAGE-217 data
presented are from pre-clinical studies and have not been validated in
human clinical trials. 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 product
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 discussions of potential risks, uncertainties, and other
important factors in SAGE's most recent quarterly report on Form 10-Q
filed with the
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