Psilocybin

Avextra leads EU-funded PsyPal project, a Phase II study on psilocybin-assisted therapy for palliative care patients with depression, funded by a €6.5 million grant from Horizon Europe. The study, starting in 2025, involves 19 partners across 9 European countries, aiming to evaluate safety, efficacy, and impact on mental health, well-being, and quality of life for patients with life-limiting diseases and their caregivers.

Psyence Biomed (Nasdaq: PBM) has executed binding agreements with Optimi Health Corp, securing exclusive worldwide supply of GMP-certified, nature-derived psilocybin for Palliative Care drug development. Optimi will also provide comprehensive Chemistry, Manufacturing, and Control (CMC) support for regulatory submissions, aiding Psyence's Phase IIb clinical trial for Adjustment Disorder in Palliative Care and future Phase III studies.

Illinois lawmakers explore psychedelics, specifically psilocybin, as a potential treatment for behavioral health issues. The Illinois CURE Act aims to legalize psilocybin for medical purposes, creating a state-regulated program. Psilocybin, currently a Schedule I drug, has been granted 'breakthrough therapy' status by the FDA.

Recent studies show psilocybin can treat severe depression and PTSD by promoting neuroplasticity. Peter Silverstone, a psychopharmacology expert, highlights psychedelics' potential as a mental health breakthrough. Despite risks, supervised use shows promise, with Alberta leading in psychedelic therapy regulation and insurance coverage. Caution is advised due to potential risks and hype.

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.