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SAGE Therapeutics (SAGE) Boss Gets Overenthusiastic About Drug, Walks Back Discussion of M&A Activity

2/17/2017 6:02:21 AM

SAGE Therapeutics Boss Gets Overenthusiastic About Drug, Walks Back Discussion of M&A Activity February 17, 2017
By Mark Terry, Breaking News Staff

Cambridge, Mass. – Jeff Jonas, chief executive officer of Sage Therapeutics (SAGE) had an interview with Doni Bloomfield of Bloomberg yesterday. The objective of the talk was to discuss the company’s Phase II clinical trial of SAGE-217 in major depressive disorder.

During the interview, Bloomfield asked Jonas about any potential deals. Jonas responded, “Our hope is that we can remain independent. We’re in great financial shape. Our studies have all performed, have all reported out well, so our hope is we can remain independent. But we are hearing a great deal from a lot of companies, especially since the depression data came out, even though it’s open label, the effect was very large. So we’ve been hearing about it, but our hope is we can remain independent.”

Investors latched onto that and the stock took a hop, although to be fair, it had been on the increase since February 10 anyway.

There was enough concern, however, that Sage released a statement today titled, “Sage Therapeutics Not in M&A Discussions.”

The company stated, “Dr. Jonas’ statements did not imply that the Company was in discussions with potential buyers. Sage remains focused on its core mission of developing novel medicines in CNS disorders. Sage will have no further comment on these matters and as a policy does not comment on speculation regarding M&A activities.”

John Carroll, writing for Endpoints News, “This for a drug that just cleared an open label trial for depression with just 13 patients in a disease that afflicts millions of people. In depression, developers typically run three big Phase III studies to see if they can come up with two that are positive, figuring that the placebo effect by itself will take down at least one of them. So this drug has quite a ways to go before anyone can start touting benefits and counting revenue.”
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In the Phase II trial, was being evaluated for safety and tolerability. It was generally well-tolerated with no serious adverse events. The study also evaluated the drug on the Hamilton Rating Scale for Depression (HAM-D) total score, as well as other secondary measures. Patients had a mean HAM-D total score of 27.2 at baseline, a mean reduction from baseline in the HAM-D of 19.9 points at Day 15, and 85 percent (11 of 13 patients) showing at least a 50 percent decrease in their HAM-D, and 62 percent (8 of 13) patients going into remission, as evaluated by a HAM-D of less than or equal to 7.

“Understanding the caveats associated with open-label data, we are highly encouraged by the strong signal we achieved in this study, which met our internal criteria for achieving a positive signal and thus supported our plan to proceed to the double-blind, placebo-controlled part of the Phase II trial,” Jonas said in a statement. “These initial results in MDD were achieved utilizing our data-driven approach to CNS drug development—employing efficient human proof-of-concept studies to both uncover activity signals and help understand future trial methodology, before investing in larger clinical programs.”

SAGE-217 is a next-generation positive allosteric modulate optimized for selectivity to synaptic and extrasynaptic GABA receptors.

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