Psilocybin

Colorado finalizes pioneering psychedelic-assisted therapy program regulations, with two facilitator licensing tracks, closely watched as a national model. The state will regulate natural medicines, with DORA overseeing training and licensing, and the Department of Revenue managing cultivation, manufacture, and testing. Local communities are establishing rules for the new industry, with some considering temporary moratoriums. High fees and costs of licensing pose challenges for practitioners.

Investors react negatively to Trump's nomination of RFK Jr. for HHS, causing COVID-19 vaccine stocks to tumble, with Moderna and BioNTech seeing significant losses. RFK Jr.'s criticism of COVID-19 vaccines and potential impact on vaccine policy contribute to investor concerns. Psychedelic drug companies, however, see stock increases due to RFK's support for the field.

CaaMTech received regulatory approval for its functional unblinding strategy in CT-4201 drug trials, addressing a major hurdle in psychedelic medicine development.

Cybin Inc. and MindMed Inc. plan to start phase 3 trials for psilocybin and LSD treatments in 2023, aiming for 2026 results. Despite recent setbacks, including FDA rejections and data issues, both companies remain optimistic, supported by FDA approvals and cautious analyst optimism.

Psychedelic drug users have a 21-fold higher risk of developing schizophrenia after ER visits, with a 3.5-fold increased risk even after controlling for existing substance use and mental health disorders, according to a Canadian study. The study, published in JAMA Psychiatry, highlights the potential risks of hallucinogen use outside clinical trial settings.

Parkinson’s disease (PD) therapeutic landscape lacks neuroprotective and disease-modifying therapies (DMTs). Current treatments focus on motor symptoms, but the pipeline in seven major markets emphasizes DMTs and non-motor symptom therapies. 66% of Phase I-III PD products are neuroprotective agents or DMTs targeting mechanisms like alpha-synuclein aggregation. Key opinion leaders (KOLs) support DMT research, highlighting the need for therapies addressing falls and non-motor symptoms. 18% of the pipeline focuses on symptom management beyond motor symptoms, and 3% targets PD-dementia and PD-psychosis, aiming to address the full spectrum of PD challenges.

Researchers, including Dr. Lynnette Averill, study psychedelics for PTSD treatment in veterans, finding rapid symptom improvement in some cases. Despite challenges, psychedelic-assisted therapy shows promise for mental health issues like depression and anxiety, offering a potential lifesaving alternative to traditional treatments.

Parkinson’s disease (PD) pipeline in 7 major markets emphasizes neuroprotective and disease-modifying therapies (DMTs), with 66% of 93 Phase I-III products targeting mechanisms like alpha-synuclein aggregation. Key opinion leaders (KOLs) support DMT research despite variability in PD pathogenesis, and 18% of the pipeline focuses on non-motor symptoms and postural instability. 3% targets PD-dementia and PD-psychosis, reflecting a comprehensive approach to address both motor and non-motor challenges in PD patients.

Relmada Therapeutics focuses on developing REL-1017 for MDD, with an interim analysis for the Reliance 2 Phase 3 study expected by year-end 2024. The company reported a decrease in cash and investments to $54.1 million and a net loss of $21.7 million for Q3 2024, with increased R&D spending. Ongoing studies include a Phase 1 safety study for a psilocybin-based candidate and plans for a Phase 2a study in 2025.

Veterans face significant mental health challenges post-deployment, with 22-44 suicides daily. New treatments like psilocybin for drug-resistant depression and PTSD are needed, despite controversy. Senate Bill 3695 aims to expand research on medicinal-only use of psilocybin in clinical settings.