- Millions of people in North America report major depression concerns
- Sage Therapeutics drug trials return dramatic data
- Testing phase targets central nervous system biomolecule receptors
Biopharmaceutical company Sage Therapeutics, Inc. (NASDAQ: SAGE) is reporting optimism over recent product testing in its efforts to reduce the debilitating effects of central nervous system disorders such as depression in its varied forms. Company CEO Jeff Jonas told a CNBC interviewer this month that he’s hopeful a pill now known as SAGE-217 may even become as prominently recognized as Prozac in the treatment of major depressive disorder (MDD), or clinical depression (http://dtn.fm/p80OC).
“What we saw in this study was a reduction to such a degree that two-thirds of the patients nearly achieved remission, which is elimination of depressive systems, by two weeks… I’ve been doing this for 20 years, and I don’t think I’ve ever seen data this dramatic in a mid-stage trial,” Jonas said during the ‘Power Lunch’ interview.
MDD reportedly affects millions of people in North America, the principle geographical region where it is recognized and treated globally. In 2015, nearly seven percent of U.S. adults reported episodes of MDD that affected aspects of their lives including appetite, sleep, interest in once-enjoyable activities, ability to reason and act, and, in some cases, their will to live, according to Healthline Media (http://dtn.fm/2rbKm).
“There are currently significant gaps in the disease management of depression and our development goal at Sage is to change patients’ expectations by transforming the treatment landscape for MDD,” Dr. Steve Kanes, chief medical officer for Sage Therapeutics, stated in a December news release (http://dtn.fm/7oCR9).
In November, Sage Therapeutics reported its lead experimental product for intravenously treating postpartum depression — brexanolone, or SAGE-547 — helped women with moderate to severe afflictions by statistically significant margins over placebo in third-stage testing (http://dtn.fm/bD69X). SAGE-217 has just completed smaller scale second-stage testing, but Jonas said the company is confident that the positive results will continue through the next phase of trials as it works with the FDA on potential market approval.
SAGE-217 would offer a side effect and efficacy profile distinct from any other product, as the company works on “brand new science” to calm down the brain, according to Jonas.
“The one challenge is that people are going to have to clear their minds of the old style of thinking about what … anti-depressants do and what they need to do. So we’re going to have to be very innovative in designing our Phase 3 program. We obviously will need one, and that’s the work we’re undertaking right now,” he said.
The company’s products target gamma-Aminobutyric acid (GABA) system receptors in the central nervous system, which are responsible for reducing neuronal excitability and N-methyl-D-aspartate (NMDA) system receptors in nerve cells. The double-blind SAGE-217 test involved 89 eligible patients who reported no serious or severe adverse side effects during the trials involving the neuroactive steroid’s effects on the GABA system. In addition to MDD, the trials analyze the drug’s response to postpartum depression and to the movement disorders essential tremor and Parkinson’s disease.
The company’s portfolio includes anticipated product trials for SAGE-718, which will target “cerebrosterol deficit disorders, Anti-NMDA Receptor Encephalitis and other indications involving NMDA receptor hypofunction” in the hope of eventually developing ways of treating conditions such as depression, Alzheimer’s disease, attention deficit hyperactivity disorder, schizophrenia, Huntington’s disease, and neuropathic pain.
For more information, visit the company’s website at www.SageRx.com
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