Sage Therapeutics, Inc. (SAGE): Lead Drug Is More Than Just A "Band-Aid" - A Scientific Response To The Short Report
$SAGE
A short report published on March 23 challenged the virtues of Sage’s lead drug candidate, SAGE-547. We consulted with one of our scientific advisors to revisit our assessment of the company’s lead program. The following report provides a more in-depth scientific analysis of SAGE-547 that rectifies the salient misconceptions presented in the short thesis.
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The use of SAGE-547 is NOT intended to address the
underlying etiology of SRSE, but rather to help halt the seizure and wean the
patient off of the anesthetic. It is
just as imperative to halt the seizure and stop the administration of an
anesthetic as it is to address the underlying etiology. The longer a
patient is in SE/RSE/SRSE the greater the probability that he/she will
experience permanent neurological damage or death.
- Although SAGE-547 is a positive modulator of the GABAA receptor, such as many of the other GABAergic agents, the mechanism of action and the binding sites are in fact NOT identical to that of standard drugs used for SE/RSE/SRSE.
- Not only does SAGE-547 act as a positive allosteric modulator, but it also acts as an agonist with distinct binding sites from GABA, which is a unique property not shared with other allosteric modulators of GABAA receptors.
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Any attempt to compare data from the SAGE-547 Phase
1/2 study with those of an ongoing prospective study with only preliminary
results published will be met with serious difficulties due to a
lack of consistency in protocol, definitions, and other important variables
such as quality of health management, availability, quality, and condition of
medical equipment used, and experience in dealing with SE/RSE/SRSE.
While all Phase 3 studies inherently involve a significant level of risk, assessing the likelihood of success of STATUS based on the superficial analysis from the short report poses a daring and unwise proposition.
Rather, the scientific virtues of SAGE-547 described in this analysis that debunk the salient features of the short report should be considered to better weigh the risk-reward of its outcome when it reports topline data in the second half of the year.
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