
Relmada reports a PhIII fail, blaming 'paradoxical' placebo effect — shares wiped
A Florida biotech attempting to develop a rapid-acting antidepressant ran face-first into a brick wall Thursday.
Relmada Therapeutics reported a Phase III fail for its lead compound, REL-1017, in major depressive disorder, noting the program did not separate from placebo after 28 days in a depression rating scale measuring severe episodes. Though the data were numerically similar, Relmada did not report a p-value to illustrate by how much REL-1017 whiffed.
Investors were having none of it. Before the market opened Thursday morning, Relmada shares $RLMD cratered nearly 80%, sending the stock price to its lowest point in more than three years.
Researchers were attempting to show an antidepressive effect using the Montgomery-Asberg Depression Rating Scale, which quantifies the severity of depressive episodes in adults. After 28 days, patients who took the drug saw their scores decrease by 14.8 points compared to 13.9 points from those on placebo.
Relmada blamed an unforeseen spike in the placebo responses, describing results from certain trial sites as “paradoxical.” The biotech says it will try to figure out why this proved to be the case, going as far as to say a post-hoc analysis that excluded the questionable sites showed a statistically significant benefit.
The goal is to create a depression drug that acts rapidly, as opposed to approved SSRIs that may take weeks to start working. The FDA approved a rapid-acting NMDA receptor antagonist for MDD in August, to be marketed as Auvelity by Axsome Therapeutics.
Relmada is running two additional Phase III studies to see if REL-1017 works in combination with other therapies. But Thursday’s failure makes the biotech’s margin for error razor-thin given this is Relmada’s only clinical program.
Previous studies had shown two dose levels to be effective in treatment-resistant depression. REL-1017 is designed as a pill taken orally once per day. The biotech’s other program focuses on psilocybin and its derivates after signing a license agreement last year with Arbormentis.