Relmada blames placebo for its depression woes

In REL-1017, Relmada Therapeutics had hoped it had an oral NDMA receptor blocker that could stop depression without the mind-altering side effects of other drugs in this class, such as ketamine. Those hopes are now in tatters after the group’s sole project flunked its first phase 3 trial, Reliance III. Relmada, whose stock plunged 79% this morning, blamed a high placebo response and noted that at some study sites placebo outperformed REL-1017 on the primary endpoint, the Montgomery-Asberg depression rating scale. The company pointed to a post-hoc analysis that excluded sites with “implausibly high or low placebo responses”, but the result cannot bode well for the rest of the pivotal programme; two adjunctive pivotal trials are also set to read out this year. Investors saw Relmada’s pain as Axsome’s gain – the latter got approval in August for its oral drug Auvelity, which acts on the NMDA receptor among other things. Axsome opened up 7% today. Johnson & Johnson’s Spravato is another marketed NMDA blocker, but is inhaled, and can only be given under supervision in a healthcare setting because of the risk of side effects and potential for abuse.