Little Marinus sees its shares eclipsed as the Sage rival fails to compare on PPD in PhII
The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.
Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.
Researchers spotlighted improvements on patients’ HAM-D17 score of 6.1 points at 6 hours and 7.7 points for 24 hours — zilch at 28 days. And the principal investigator said that the safety profile indicated that they could up their dose in future studies. But Andrew Tsai at Jefferies had excitedly forecast that Marinus could see a big spike if they could show off a 13 to 15 point improvement by day 28. That would have put them in the same ballpark as Zulresso.
Left out of the ballpark entirely, their stock collapsed, eliminating 64% of their value.
Sage execs had already shrugged off the potential rival.
“I think we’re in two very different worlds, both scientifically at this point and strategically as well,” Sage chief medical officer Steve Kanes told Endpoints News back in January.
The execs at Marinus, though, will stick it out with a stiff upper lip and a determined countenance.
“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,” said executive chairman Scott Braunstein in a prepared statement. “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.”
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