Supernus Pharmaceuticals’ mTORC1 activator has cleared a small trial in patients with major depressive disorder, potentially bringing the biotech one step closer to offering a treatment that could be effective within hours.
In the Phase 2a study’s primary endpoint, Supernus’ SPN-820 given every three days on top of baseline antidepressants achieved a 9.6-point reduction in the Hamilton Depression Rating Scale – 6 Items (HAM-D6) total score at 10 days, according to a Thursday release. Supernus said the effect was “rapid and substantial,” with a 6.1-point reduction seen at just two hours.
Stifel analysts said the results moved patients from “high-to-moderate” or “low-to-severe” depression at baseline to “normal-to-mild” depression after treatment, which “far exceed[s] the meaningful clinical thresholds” for the scale. The drug’s rapid effect and convenient oral dosing is “highly valuable” because most antidepressants take at least a week before patients see an improvement, the analysts added.
The open-label study enrolled 40 adults with major depressive disorder, all but two of whom finished the 10-day treatment period.
The company said SPN-820 was well-tolerated in the study with adverse events including headache (20%), nausea (20%) and sleepiness (15%). But the analysts said the trial’s small patient numbers and open-label design mean conclusions on safety are limited.
Elsewhere, Supernus is recruiting for a Phase 2b study of the same drug dosed daily in people with treatment-resistant depression. The biotech expects to complete enrollment of 236 participants in November, with topline data anticipated in the first half of next year. The primary endpoint is change in Montgomery-Asberg Depression Rating Scale total score at five weeks.