Marinus Pharmaceuticals (NASDAQ:
MRNS) plummets
68% premarket on increased volume in response to
results from the second part of a Phase 2 clinical trial, MAGNOLIA, evaluating intravenously administered ganaxolone followed by daily oral ganaxolone in women with postpartum depression (PPD).
The treatment effect, as measured by a depression scale called HAM-D17, at six hours and 24 hours after the start of therapy was not statistically significantly different from placebo.
33 patients were enrolled in Part 2 with similar baseline HAM-D17 scores between the treatment and control groups (26.6 and 26.4, respectively).
In the per protocol population, the mean reduction in HAM-D17 score in the ganaxolone group was 6.5 points compared to a mean reduction of 3.1 points for placebo at hour 6 and reductions of 7.5 points and 4.8 points, respectively, at hour 24.
Despite the setback, Executive Chairman Dr. Scott Braunstein says, “We have methodically evaluated treatment paradigms for ganaxolone in PPD and, based on these data, we are confident in a path forward for IV ganaxolone. We believe that ganaxolone has demonstrated a competitive profile in terms of safety/tolerability, early onset of action and ease of administration, which will be meaningful for both patients and physicians. We look forward to meeting with regulators to discuss the development pathway for IV ganaxolone in PPD. Our team will continue to explore the development of ganaxolone in other severe depressive disorders while remaining committed to advancing our exciting programs in orphan epilepsies and refractory status epilepticus.”
