Investigators at Relmada Therapeutics Inc. believe the same problem that plagued an earlier phase III effort called Reliance-3 – an “implausibly” high placebo response at certain sites – also foiled the latest phase III study (conducted at overlapping sites) known as Reliance-1, testing REL-1017 (esmethadone), meant as an adjunctive treatment for major depressive disorder.
Relmada Therapeutics Inc. is scratching its collective chin as it sifts through data from the failed phase III Reliance III study of REL-1017 (esmethadone) in treating major depressive disorder (MDD). A higher-than-expected placebo response, however, prompted the company to label the study’s results as “paradoxical.”
Gate Neurosciences Inc. was first founded in 2019, but officially launched last week with two clinical-stage assets and a bold goal: to develop better drugs for CNS disorders and identify better-suited patients for those drugs. The company’s first molecular target is the NMDA receptor. Gate has acquired the rights to two NMDA receptor modulators, zelquistinel and apimostinel.
After August 2021 news from the U.S. FDA of deficiencies in the NDA that Axsome Therapeutics Inc. submitted for AXS-05 in major depressive disorder (MDD), word was especially welcome April 19 that the firm has come to an agreement with the agency with regard to post-marketing requirements. Meanwhile, another player in MDD, Relmada Therapeutics Inc., is due to report phase III data with REL-1017 (esmethadone) around the middle of this year.
Top-line data from Relmada Therapeutics Inc.'s phase II study of REL-1017 (dextromethadone) in patients with treatment-resistant depression caused the stock to more than double Tuesday, a great day on the market.