Sage scores good but not great P3 postpartum depression drug results
pharmafile | November 10, 2017 | News story | Medical Communications, Research and Development | Sage Therapeutics, biotech, drugs, pharma, pharmaceutical
Sage Therapeutics share price soared 50% on the release that its two Phase 3 trials of brexanolone showed statistically significant results in the treatment of postpartum depression (PPD).
This rapid and immediate rise suggests that there is significant faith that its drug could become a major seller for the 10 to 20% of women affected by the condition.
Sage plans on filing with the FDA for a NDA for the drug but there are significant questions over just how effective the treatment is; these questions may well give the FDA pause for thought over the drug.
In the studies, the efficacy of the drug was measured by changes on the 29 point HAM-D scale, a measure of depression, and both studies managed to hit their primary endpoint.
In the first study, treatment of patients with severe PPD with 90mcg/kg/hour improved symptoms as measured by the scale by 17.7 points, three greater than those on placebo; at a lower dose of 60mcg/kg/hour, patients improved by 19.9 points, 5.9 better than placebo.
In the second study, looking at patients with moderate PPD, brexanolone, at the higher dose of 90mcg/kg/hour, only managed to measure an improvement of 2.2 over placebo.
This represents a drop from the previous Phase 2 trial into the drug, that saw a 12 point improvement reduction over placebo – though this study only contained 10 women.
The drug was found to have an impact after 48 hours and this lasted up until the 30 day in the first study; however, in the second study, the statistical significance measured at 48 hours was not maintained through to day 30, though that measured at 60 hours did continue through on the 30 day follow-up.
There are a number of questions raised by such results, such as how effective it is over longer periods, the fact the lower dose seemed to be more effective in the first study and the marginal improvements in those with moderate PPD.
Treatments for depression are notoriously difficult to measure in new treatments, with strong placebo results often skewing results. It remains likely that the drug may well get the nod from the FDA, however, with a required 60-hour infusion of the drug, it will draw a question of how many people within its wide market will be recommended the treatment.
This will not stop the results being viewed as success for Sage, especially coming after a failure in Phase 3 for the same drug in epilepsy.
“This is the first Phase 3 program conducted specifically in women with PPD and these results exemplify the value of Sage’s distinct approach to clinical research,” said Jeff Jonas, CEO of Sage. “We are pleased with the findings, specifically the rapid onset of action and duration of effect observed in all arms of the Hummingbird program. We believe the data represent an unprecedented opportunity in the development of treatments for PPD, and may serve as the catalyst for a paradigm shift in how the disease is approached and, if approved, may change how PPD is treated.”
Ben Hargreaves
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