Psilocybin

Psilera's PSIL-006, a non-psychedelic psilocybin-based drug, shows promise in treating frontotemporal dementia (FTD) with a strong safety profile in preclinical studies, potentially paving the way for FDA approval and addressing a critical need in dementia care.

Psyence Biomedical completes first site initiation visit for Phase IIb study of nature-derived psilocybin for Adjustment Disorder in Palliative Care, with patient screening to start soon and first subject expected in October.

Psyence Biomedical Ltd. completed the first site initiation visit for its Phase IIb study of nature-derived psilocybin as a potential treatment for Adjustment Disorder in Palliative Care. The study, supported by partnerships with Fluence and iNGENū CRO, will evaluate two therapeutic doses of psilocybin (10mg, 25mg) against a low-dose comparator (1mg) in 87 patients. Patient screening will commence soon, with the first subject expected to be randomized in October. Topline data is anticipated in the second half of 2025, potentially leading to a Phase III clinical program.

FDA advisory panel rejected MDMA-assisted therapy for PTSD due to concerns over clinical trial design, potential abuse, and misconduct allegations. April Pride, CEO of SetSet, views this as a setback for psychedelic medicine, advocating for regulatory reforms and harm-reduction education. Despite the rejection, Pride remains optimistic about the future of psychedelic medicine, expecting innovation in safer compounds and protocols.

Classic psychedelics like LSD and psilocybin are well-tolerated in clinical settings, with serious adverse events being rare, according to a study in JAMA Psychiatry. However, incomplete adverse event reporting highlights the need for improved safety monitoring. The study found no serious adverse events among healthy participants, but about 4% of those with neuropsychiatric disorders experienced serious events. The research emphasizes the need for rigorous pharmacovigilance practices to accurately quantify risks and benefits.

Psyence Biomed to acquire Clairvoyant Therapeutics, which is conducting a Phase IIb clinical trial for a synthetic psilocybin candidate for Alcohol Use Disorder (AUD). Topline data expected in early 2025.

Mindstate Design Labs received FDA and EMA approval for human trials of MSD-001, described as 'psychedelic tofu' for its mild effects. The trials aim to validate the neurotech AI platform, Osmanthus, designed to create tailored altered states of consciousness. CEO Dillan DiNardo envisions using psychedelics as tools to understand and design specific mental states, potentially addressing conditions beyond traditional psychedelic uses.

Interventions for treatment-resistant depression (TRD) include augmentation and switch pharmacotherapy, psychotherapy, electroconvulsive therapy (ECT), and repetitive transcranial magnetic stimulation (rTMS). The STAR*D study guided TRD treatment for 20 years, showing difficulty in achieving remission. Since then, new treatments like atypical antipsychotic augmentation, intranasal esketamine, and rTMS have emerged, with rTMS being a significant advancement due to its efficacy and neuroscience-based tools for optimization. Recent studies like Dalhuisen et al. and ASCERTAIN-TRD suggest rTMS is more effective than pharmacotherapy in TRD, potentially positioning it earlier in treatment algorithms.

On Aug. 29, 2024, at 6 p.m., 'Health Matters' discusses methamphetamine addiction with Dr. Shawn McNeil, Kevin Murnane, PhD, and Frances Vest, focusing on a psilocybin clinical trial at LSU Health Shreveport. Call 1-800-552-8502 for questions.