Psilocybin

Relmada Therapeutics halts Phase 3 studies of depression treatment REL-1017, exploring strategic alternatives due to financial pressure. The company will continue development of REL-P11, a modified psilocybin compound, and plans to engage a financial advisor for strategic review.

The podcast discusses the psychedelics industry's current state, focusing on clinical trials for psilocybin therapies by companies like Compass Pathways and Cybin. Despite reduced investor interest due to hype and regulatory challenges, positive phase 3 trial results could reignite investment. The industry faces unique hurdles, including legal and testing complexities, but companies are innovating with patents and different therapeutic approaches.

A&F interventions reduced antibiotic prescribing by 11-23% across 4 metrics in primary care, with larger reductions in low-income countries and with monthly feedback.

Colorado will offer regulated psilocybin therapy starting in 2025, with applications for facilitators and businesses opening on Dec. 31. The first healing centers are expected to accept patients by summer 2024. The program, developed since Proposition 122 passed in 2022, aims to address mental health issues and mirrors Oregon's model with added safety measures. Local municipalities can regulate where these businesses operate, with some already setting restrictions.

The push to mainstream psychedelic ibogaine for PTSD treatment gained momentum during the 2024 election, with advocates hopeful about Robert F. Kennedy Jr.'s nomination as Secretary of Health and Human Services. Ibogaine, derived from the Gabonese shrub Tabernanthe iboga, has shown promise in reducing PTSD, anxiety, and depression symptoms by over 80% in a Stanford study. Despite legal barriers, companies like mPath Therapeutics aim to produce GMP-certified ibogaine in Jamaica for global use, addressing the urgent need for innovative PTSD treatments among veterans and opioid addicts.

A study from Emory University suggests that FDA approval of Psilocybin-assisted therapy (PSIL-AT) could benefit 5 million people with Major Depressive Disorder (MDD) and Treatment-Resistant Depression (TRD). The study estimates that between 56% and 62% of individuals currently treated for these disorders could be eligible for PSIL-AT, with potential numbers ranging from 2.2 million to 5.6 million for MDD and 0.6 million to 1.7 million for TRD. However, uncertainties remain regarding access to trained providers and state-level regulations.

Scientists are re-evaluating psychedelics' medicinal potential, with clinical trials underway for depression, anxiety, PTSD, and more. WashU Medicine researchers aim to transform psychedelics into safe, effective therapies using modern neuroscience. A study by WashU Medicine neuroscientists showed psilocybin disrupts brain's default mode network, correlating with mystical experiences. Psychedelic-assisted therapy, combining medicine and psychotherapy, offers rapid treatment for mental health disorders. WashU's Center for Holistic Interdisciplinary Research in Psychedelics (CHIRP) supports equitable, affordable psychedelic treatments. Despite FDA's rejection of MDMA for PTSD, public and scientific interest in psychedelics remains high, with ongoing research and funding opportunities.

Psyence Biomedical (Nasdaq: PBM) reports significant progress, including advancing its Phase IIb clinical trial for nature-derived psilocybin in Palliative Care patients with Adjustment Disorder, doubling its PsyLabs stake value to $2 million, and strengthening its financial position through debt-for-equity swaps. PBM aims to be substantially debt-free by 2025 and expects to regain Nasdaq compliance by year-end, with topline data from the Phase IIb trial anticipated in H2 2025.

Navy SEALS face severe physical and mental health issues post-deployment, including PTSD and depression. 'In Waves and War' documents their struggles and an experimental ibogaine treatment in Mexico offering hope. Despite its benefits, ibogaine's Schedule I status in the U.S. limits access, highlighting a need for regulatory change and more research.

Psilocybin mushrooms, or “magic mushrooms,” contain psychoactive compounds that affect mood and perception by interacting with serotonin receptors in the brain. Historically used in spiritual practices, particularly in Mesoamerican cultures, psilocybin is gaining attention for its potential to treat depression, anxiety, PTSD, and addiction, with promising results from clinical trials. However, their use carries risks, including psychological distress, especially for those with mental health conditions. While psilocybin remains illegal in many places, decriminalization and medical research are increasing, particularly in areas like Oregon. Caution is advised due to potential misidentification and psychological effects.