What to Expect from Sage Therapeutics’ Brexanolone
Sage Therapeutics’ (SAGE) Brexanolone, also known as SAGE-527, is an allosteric modulator injection under investigation. The product is based on the GABAA receptor program.
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The above chart shows details about the investigational drug SAGE-527.
The drug SAGE-527 is under Phase III development for the treatment of postpartum depression. SAGE-527 was also being evaluated for the treatment of super-refractory status epilepticus (or SRSE) under STATUS trial. However, on September 12, 2017, the company announced the top-line results from the STATUS trial, indicating that Brexanolone didn’t meet its primary endpoints.
The status trial is the abbreviated form of SAGE-547 treatment as adjunctive therapy utilized in status epilepticus. The study was a phase III, double-blind, randomized, placebo-controlled study that evaluated the safety and efficacy of the SAGE-547 injection for the treatment of SRSE.
The efficacy results showed that 43.9% of patients treated with Brexanolone were successfully weaned from the third-line agents as compared to 42.4% of patients treated with the placebo. Also, nearly 37% of patients treated with brexanolone after the double-blind period ended reported treatment response.
The safety results showed adverse effects in almost all patients, considering the complexity and severity of the disease SRSE and other ongoing treatments. However, the serious adverse events, death rates, and discontinuation of treatment due to adverse events were similar in the Brexanolone and placebo treatment groups.
To divest the company-specific risks, investors can consider ETFs like the iShares NASDAQ Biotechnology ETF (IBB), which holds 0.5% of its total assets in Sage Therapeutics (SAGE). IBB also holds 9.0% in Biogen (BIIB), 8.9% in Gilead Sciences (GILD), and 3.4% in Incyte (INCY).