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SAGE Therapeutics' Lead Candidate to Enter Phase III Study - Analyst Blog

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SAGE Therapeutics SAGE announced the details of a global phase III program on SAGE-547 for the treatment of patients suffering from super-refractory status epilepticus (SRSE).

SAGE Therapeutics met the FDA recently in an end-of-phase II meeting. The company said that the agency agreed on its design and key elements for a phase III program for SAGE-547. The company expects the phase III results along with other data from the development program on SAGE-547 to form the basis of submitting a new drug application for SAGE-547 for SRSE.

The randomized, double-blind, placebo-controlled phase III study will assess the efficacy and safety of SAGE-547 in SRSE patients aged two years and above. SAGE Therapeutics intends to start patient enrollment by mid-2015, after the submission and FDA review of the final study protocol and updated chemistry, manufacturing and controls information.

The primary endpoint of the study will be successful resolution of status epilepticus after weaning the patient off all third-line anti-seizure agents as well as SAGE-547 or placebo, without resumption of the disease within 24 hours post completion of blinded treatment with SAGE-547 or placebo.

According to the press release issued by SAGE Therapeutics, status epilepticus is a life-threatening seizure condition affecting almost 150,000 people in the U.S. every year with 30,000 patients dying from the disease.

Since SAGE-547 is the lead candidate in SAGE Therapeutics pipeline, its successful development and commercialization should solidify the company's growth trajectory. Given that no treatment has yet gained approval for the treatment of SRSE exclusively, (although we note that physicians prescribe anesthetic agents for stopping the seizure instantaneously by inducing coma), there is an urgent need for bringing new therapies to the market. Hence, SAGE-547 may gain a strong a foothold in this market, upon approval. The candidate enjoys fast track and orphan drug designation in the U.S. for the treatment of SRSE.

Meanwhile, SAGE Therapeutics is working on further development of SAGE-547. The company is enrolling patients in an expansion cohort under a protocol amendment for the open-label phase I/II SAGE-547 study, for the treatment of pediatrics aged two years with an investigational higher dose regimen of SAGE-547. Final data from this study will be presented at the Antiepileptic Drug and Device Trials Conference to be held between May 13 and May 15 this year.

SAGE Therapeutics carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Lannett Company, Inc. LCI , Cytokinetics, Inc. CYTK and ANI Pharmaceuticals, Inc. ANIP . All these stocks carry a Zacks Rank #1 (Strong Buy).

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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