Relmada Therapeutics Reevaluates Psilocybin Program Amid Shifting Industry Landscape

Relmada Therapeutics, a biopharmaceutical company known for its innovative approach to drug development, is reconsidering its plans to test a magic mushroom extract for obesity and metabolic diseases. This strategic shift comes as part of a broader reassessment of the company's research priorities and pipeline focus.

Phase 1 Results and Strategic Reconsideration

In November 2024, Relmada launched a phase 1 study of REL-P11, a low-dose formulation of psilocybin extracted from magic mushrooms. The company had initially planned to progress to a phase 2 study in the first half of 2025, based on promising preclinical rodent data that suggested potential efficacy in treating obesity and metabolic syndrome.

However, in its recent full-year earnings report, Relmada announced it is "re-evaluating further development" of REL-P11. Chief Financial Officer Maged Shenouda explained, "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."

Shifting Focus and Pipeline Priorities

As Relmada reconsiders its psilocybin program, the company is redirecting its efforts towards other promising candidates in its pipeline:

1. NDV-01: A sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. Topline data from a phase 2 study are expected to be presented at a conference next month.

2. Sepranolone: A GABA-A modulating steroid antagonist licensed from Asarina Pharma in February 2025. Phase 2 studies in Tourette syndrome and Prader Willi syndrome are slated to begin between Q4 2025 and early 2026.

These developments come in the wake of Relmada's decision to discontinue two phase 3 trials for REL-1017, an NMDAR antagonist being investigated for depression, at the end of the previous year.

Financial Position and Industry Context

Relmada reported a solid financial position, with $44.8 million in cash reserves at the end of 2024. CFO Shenouda emphasized that the company entered 2025 "with solid financial strength."

The reassessment of Relmada's psilocybin program occurs against the backdrop of ongoing research into psychedelics for various mental health conditions across the pharmaceutical industry. Companies like Cybin and Compass Pathways continue to advance their own psilocybin-derived compounds for conditions such as major depressive disorder, with phase 2 and phase 3 data expected in the near future.