Fresh off a big victory in a clinical trial of a postpartum depression treatment, Sage Therapeutics announced yet more good news Thursday: Positive results from a mid-stage clinical trial for a pill to treat people with major depressive disorder. The drug appears to work quickly, though its effects diminish over time.
If Thursday’s results are confirmed in later phase 3 clinical trials, the Cambridge biotech’s pill could become one of the first medicines in years with a new mechanism of action to be approved for the treatment of depression.
And for Sage, helping lift depression in patients could generate $1 billion or more in sales.
The company’s stock soared on the news, closing up more than 70 percent to $156.27.
The new data make Sage an attractive buyout candidate for a larger pharma company because wholly owned, effective neuro-psychiatric drug candidates are rare and valuable — particularly medicines that can be taken orally and lack significant side effects.
In the clinical trial, treatment with the experimental drug for 14 days led to a statistically significant average reduction in the Hamilton Rating Scale for Depression of 17.6 points, compared with 10.7 points for a placebo.
Sixty-four percent of the patients treated with the drug, known as SAGE-217, achieved remission, meaning that their depressive symptoms completely disappeared. By comparison, 23 percent of the placebo patients achieved remission. The difference was statistically significant.
SAGE-217 was found to be safe, with no serious adverse events reported. The most common side effects were headache, dizziness, and nausea.
“These very encouraging data suggest the potential of SAGE-217 in the treatment of major depressive disorder as well as other mood-related disorders that we may pursue. There has been little innovation in the discovery and development of treatments for depression in the last two decades,” Sage’s chief executive, Jeff Jonas, said in a statement.
The study was not without question marks. Sage-217 works within days to lift depressive symptoms, but the drug’s effect wanes over time. In the study, dosing was stopped after 14 days, but patients were followed longer. At six weeks, patients treated with SAGE-217 showed a 15 point reduction in the depression-rating score, compared to 13 points for the placebo patients — a difference that was not statistically significant.
Likewise at week six, 45 percent of SAGE-217 patients had achieved remission, compared to 33 percent of placebo patients — not statistically significant.
Leerink analyst Paul Matteis said that using a 14-day end-point is shorter than typical depression drug studies, but any amount of off-drug durable benefit could help Sage differentiate SAGE-217 from conventional antidepressants.
Referring to the overall study results, Matteis said, “It’s hard to understate how meaningful these data are in the backdrop of the very significant unmet medical need in depression.”Adam Feuerstein
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