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Sage Therapeutics Announces Initiation of Phase 2 Clinical Development for SAGE-217 in Movement Disorders
First patient dosed in Phase 2 proof-of-concept trial of SAGE-217 in Parkinson's disease
Trial sites are open and screening patients for the Phase 2a trial in essential tremor; patients expected to be dosed imminently
"Sage continues to pioneer innovative approaches to neuroscience drug
development in CNS indications with high unmet need where we can
redefine treatment paradigms," said
"Administering the first dose of SAGE-217 in a proof-of-concept study in
Parkinson's disease and the initiation of SAGE-217 in essential tremor
illustrate major progress in Sage's effort to address the serious need
for additional effective treatments for these movement disorders and in
building our multi-product, neuropsych portfolio," said
The essential tremor study is a Phase 2a double-blind, placebo-controlled, randomized withdrawal study that will evaluate the efficacy, safety, tolerability and pharmacokinetics of SAGE-217 in approximately 60 patients with essential tremor. The primary endpoint of the study is to compare the effect of one week of SAGE-217 on overall kinetic tremor symptoms. Secondary endpoints include additional accelerometer-derived and clinician-rated rating scales.
The Parkinson's disease program is a two-part Phase 2 clinical trial
evaluating the safety, tolerability, pharmacokinetics and efficacy of
SAGE-217 in moderate Parkinson's disease patients. Part A of the Phase 2
trial will be an open-label, proof-of-concept study evaluating SAGE-217
in approximately 18 patients which, if promising, may lead to a
randomized, placebo-controlled Phase 2 trial. The primary endpoint for
the Part A study will be to evaluate the safety and tolerability of
SAGE-217. The secondary endpoint will be to evaluate improvement in
motor symptoms as assessed by the change from baseline after one week in
the
About SAGE-217
SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABA receptors and a pharmacokinetic profile intended for daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and CNS, and contributes significantly to regulating CNS function. In a Phase 1 clinical program, SAGE-217 was well-tolerated in single and multiple ascending doses and the results were consistent with the predicted pharmacokinetic and pharmacologic profile. SAGE-217 is currently being developed for certain mood and movement disorders. A Phase 2 clinical trial in Parkinson's disease is ongoing and initiation of dosing in the essential tremor study is pending. Phase 2 clinical trials in postpartum depression and major depressive disorder are planned.
About Essential Tremor
Essential tremor is a common neurological condition that affects an
estimated 6 to 7 million in the
About Parkinson's Disease
Parkinson's disease is a progressive neurodegenerative disorder that
affects an estimated 700,000 patients in the
About
Forward-Looking Statements
Various statements in this release concern Sage's future expectations, plans and prospects, including without limitation: our expectations regarding development of SAGE-217 and our other product candidates and their potential in the treatment of various CNS disorders; the expected initiation and timing of clinical trials and anticipated availability and announcement of data and results; our estimates as to the number of patients with essential tremor and Parkinson's disease and our belief as to unmet need in these populations. 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 experience slower than expected clinical site initiation or enrollment in our clinical trials, or the potential need for additional analysis or data or the need to enroll additional patients, leading to possible delays in completion of trials or in the availability of data; we may not be able to generate supportive non-clinical data or to successfully demonstrate the efficacy and safety of our product candidates at each stage of development; success in our non-clinical studies or in earlier stage clinical trials may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates, and ongoing and future pre-clinical and clinical results may not support further development of product candidates or be sufficient to gain regulatory approval to market any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical studies of a product candidate or to obtain marketing approval; we may encounter adverse events at any stage of development that negatively impact further development; the actual size of the essential tremor and Parkinson's disease patient populations may be significantly lower than our estimates; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; and we may encounter technical and other unexpected hurdles in the development and manufacture of our products which may delay our timing or increase our expenses and use of cash, as well as those risks more fully discussed in the section entitled "Risk Factors" in our most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.
1 Louis ED,
2 Willis et al, Neuroepidemiology. 2010;34:143-151
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