Shares of SAGE Therapeutics (NASDAQ:SAGE) popped in early trade after the biopharma company said the US Food and Drug Administration is allowing it to expedite the development of its lead drug SAGE-217 to treat post-partum depression as well as depression of other kinds.
Sage intends to accelerate the bringing of SAGE 217 to market with the help of clinical trials. In a new placebo-controlled Phase 3 trial, which is set to begin in the second half of the year, patients with major depressive disorder will receive doses of SAGE 217.
The company also plans to continue with its ongoing placebo-controlled trial in women with post-partum depression, which is now designated as a pivotal trial.
In response to the news, SAGE shares jumped 14% to US$167.88 in morning trade.
Both trials are also designed to analyze the concept of episodic dosing or a short-course of treatment with SAGE 217 and its effect on the reduction of depressive symptoms compared to a placebo.
“In this development program, we are exploring the potential for patients with major depressive disorder to feel well within days, with just a two-week course of treatment – similar to how antibiotics are used today- instead of enduring long-term chronic treatment,” said Sage’s CEO Jeff Jonas.
SAGE expects to announce top-line data from the placebo-controlled pivotal trial of SAGE 217 in patients with post-partum depression in the fourth quarter of this year.
SAGE received the sought-after Breakthrough Therapy designation from the FDA to use SAGE 217 to treat major depressive disorders last February.