Relmada Therapeutics’ attempts to see whether a magic mushroom extract could be used to treat obesity and metabolic diseases may be coming to an end before they really began.
The biotech launched a phase 1 study in November 2024 of its low-dose formulation of psilocybin—which is extracted from so-called magic mushrooms—for metabolic disease. At the time, Relmada pointed to preclinical rodent data that it claimed showed the therapy, dubbed REL-P11, “could have potential to become a valuable therapeutic option in the evolving obesity and metabolic syndrome space.”
The plan had been to use the first clinical trial to warm up for the launch of a phase 2 study in the first half of 2025. But in its full-year earnings results, Relmada said it is now “re-evaluating further development” of REL-P11 “as part of our prioritization efforts.”
“While results of the phase 1 study indicate that REL-P11 is well tolerated, our emphasis on focused patient populations and the increasingly competitive clinical development landscape in metabolic disease have prompted our review,” Relmada’s Chief Financial Officer Maged Shenouda said in the March 27 release.
Psilocybin has appeared in a number of biotech pipelines as the sector investigates whether psychedelics could improve treatment for mental health conditions such as depression and post-traumatic stress disorder. Five months ago, Cybin posted phase 2 data suggesting its psilocybin-derived compound could help treat major depressive disorder, while Compass Pathways is expected to report phase 3 depression data for its psilocybin therapy in the coming months.
Relmada ditched a pair of phase 3 trials for its own depression prospect, a NMDAR antagonist dubbed REL-1017, at the end of last year after the likelihood of success dimmed.
Top of the biotech’s list of priorities is NDV-01, a sustained-release intravesical formulation of the commonly used chemotherapies gemcitabine and docetaxel. Topline data from a phase 2 study in non-muscle invasive bladder cancer are due to be presented at a conference next month.
There’s also sepranolone, a GABA-A modulating steroid antagonist licensed from Asarina Pharma last month. Phase 2 studies in Tourette syndrome and Prader Willi syndrome are both expected to kick off sometime between the fourth quarter of 2025 and early 2026.
With $44.8 million in the bank at the end of 2024, CFO Shenouda said the company began this year “with solid financial strength.”