Results from SAGE Therapeutics' (SAGE) SAGE-547 Trial Encouraging, But Questions Remain - Leerink

Leerink affirms SAGE Therapeutics (Nasdaq: SAGE) at Outperform with a price target of $107 after the company announced results from a successful exploratory clinical trial of SAGE-547 to evaluate the GABAA mechanism of action as a treatment for essential tremor, a debilitating neurological disorder that causes involuntary, rhythmic shaking with no known cause that is estimated to affect more than 10 million people in the United States.

Analyst Paul Matteis commented, After 12-hour infusion, '547 was able to produce a statistically significant reduction in tremor kinetics rated by accelerometer, as well as trends on other measures of tremor severity. While we find the results encouraging, multiple questions remain including: (1) the degree to which '547's efficacy in tremor is differentiated from that of benzodiazepines, (2) whether the efficacy of '547 IV can be replicated with an oral formulation and (3) if an oral formulation is effective, will its efficacy be durable, as tremor is a chronic disease. A potential positive for the company's synaptic/extra-synaptic modulation platform, '547 was able to induce some tremor control at doses that produced little more sedation than placebo, which is noteworthy given the median age (64 years old) of the patient population as susceptibility to benzo/GABAergic-related side effects (such as sedation) increases with age.

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