Sage Therapeutics shares are once again rocketing up this morning, this time based on positive results from a small Phase II study of an oral version of their depression therapy.
Long one of the most volatile stocks in biotech, Sage says that SAGE-217 clearly hit the goal post for statistical significance in major depressive disorder, achieving a 64% success rate in achieving clinical remission on a commonly used score for depression against 23% on a placebo.
Starting wth a market cap of $3.8 billion this morning, Sage saw its shares soar 67% after the latest round of results. And now they plan to take it into late-stage development.
Just a few weeks ago Sage’s shares also rallied on the news that SAGE-547 — their infused drug — produced positive results in postpartum depression. The results waned from their mid-stage results, but investors backed the notion that Sage has something important in a field marked by repeated setbacks.
Sage also has been making big gains on data from small studies, which have to go a long way before they are fully evaluated by regulators. That challenge still remains.
Paul Matteis at Leerink wasn’t too worried about that as he jumped into the cheering section. He noted the potential of a fast, effective depression drug in a field where treatment failure is common:
For the drug arm, SAGE notes that statistical separation from baseline began at day 2. By comparison, almost all other depression trials for oral medicines run for 4-6 weeks, with the assumption that it should take this long to show an effect. It’s hard to understate how meaningful these data are in the backdrop of the very significant unmet medical need in depression: even if the SAGE data on a placebo-adjusted basis weren’t differentiated via cross-trial comparisons, we still think ‘217 would be an important drug as it offers a new mechanism (extra-synaptic GABA-modulation) in an area where the vast majority of options generally modulate the same pathways (serotonin, dopamine, norepinephrine).
Sage’s shares crumbled in September when its lead drug failed to outperform a placebo in treating a rare form of seizures. But back-to-back successes have since then more than doubled the share price, adding billions in market cap.
“These very encouraging data suggest the potential of SAGE-217 in the treatment of MDD as well as other mood-related disorders that we may pursue,” said Jeff Jonas, chief executive officer of Sage Therapeutics. “There has been little innovation in the discovery and development of treatments for depression in the last two decades. Coupled with our recent positive Phase 3 data read-out evaluating brexanolone for the treatment of postpartum depression, the findings in this study suggest our pipeline of proprietary GABAA modulators may impact novel and fundamental brain mechanisms, offering potential development opportunities in a variety of indications.”
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