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SAGE Therapeutics Initiates Exploratory Study of SAGE-547 in Essential Tremor
"SAGE-547 is a molecule with an attractive, acute therapeutic profile well-suited for exploring the impact of its mechanism on many GABA-related disorders, including essential tremor," said
This Phase 2a trial is a double blind, proof-of-concept study of SAGE-547 in patients who have a diagnosis of essential tremor with symptoms clearly present in at least one upper limb. The trial is expected to enroll 24 adult patients with essential tremor for at least 2 years, a score of ≥ 2 for at least one upper limb maneuver as measured by The Essential Tremor Rating Scale (TETRAS) performance subscale, and who are not currently taking medication for their tremor or are on a stable dose of medication for at least 28 days prior to enrollment. This trial is designed to provide clear data regarding the safety and tolerability of SAGE-547 using ratings and mechanical measures of motor activity designed to rapidly yield unambiguous endpoints. The activity of SAGE-547 will be assessed via physician examination, transducer measurement of tremor amplitude and full TETRAS and TETRAS performance subscale measurements. Patients will be administered either SAGE-547 or placebo intravenously for 12 hours on Day 1 and Day 10 in a double blind cross-over manner. Patients will be monitored for up to 30 days following treatment.
"Current treatments for essential tremor are only moderately effective, as most reduce but do not resolve tremor levels in the majority of treated patients," said
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 super-refractory status epilepticus (SRSE), as a treatment for essential tremor.
About Essential Tremor
Essential tremor (ET) is a common neurological condition that affects an estimated 10 million Americans and millions more worldwide. ET causes a rhythmic trembling of the hands, head, voice, legs or trunk. Symptoms generally evolve over time and are both visible and persistent following onset, which commonly occurs either between 15-20 or 50-70 years of age. First-line treatments for essential tremor include the anticonvulsant primidone and the β-adrenergic blocker propranolol. All current treatments for ET are only moderately effective, reducing, though not resolving, tremor amplitudes in about 50% of the patients. In addition, one out of three patients abandons treatment due to side effects or poor efficacy.
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Forward-Looking Statements
This release contains forward-looking statements and information. The use of words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "project," "intend," "future," "potential," or "continue," and other similar expressions are intended to identify forward looking statements. For example SAGE's future expectations, plans and prospects, including without limitation, SAGE's expectations regarding the potential safety, pharmacological effect and efficacy of SAGE-547 as a treatment for SRSE and essential tremor, the expected development pathway for its other product 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 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 for SRSE are preliminary in nature and that this 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. 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 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
CONTACT: Media Contact:Source:Dan Budwick ,Pure Communications dan@purecommunicationsinc.com 973-271-6085 Investor Contact:Monique Allaire ,Pure Communications monique@purecommunicationsinc.com 781-631-0759
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