As part of the renewed interest in the potential health applications of psychedelics in recent years, companies ranging from biotechnology startups to pharmaceutical giants are conducting ground-breaking clinical trials involving a range of psychedelic compounds including psilocybin, MDMA, and LSD.
The results of these trials will likely create more innovative treatments for a range of physical and mental health conditions.
It's not just Big Pharma that has its eyes firmly focused on various psychedelic clinical trials -- investors alike are eager to get eyes on results, as they can be major catalysts for psychedelics stocks, which have largely struggled to gain momentum in recent years.
In terms of trial results, the highly anticipated psychedelic research data, from a Phase 3 clinical trial sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) and its subsidiary the MAPS Public Benefit Corporation (PBC), was already published in January.
MAPS PBC's second, confirmatory trial evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD) was so highly anticipated because it could result in the US Food and Drug Administration approving MDMA-assisted therapy as early as 2024.
The first Phase 3 trial, in 2021, demonstrated MDMA-assisted therapy to be a safe and effective treatment for patients with PTSD, with 88% of the trial participants seeing a clinically significant reduction in their PTSD symptoms two months after their final session.
The second trial also met its primary and key secondary endpoints and will support a new drug application submission to the FDA expected in the third quarter of 2023, MAPS PBC said when it released the trial results earlier in 2023.
Where are we at with other clinical trials?
New York-based biopharmaceutical company MindMed (NASDAQ:MNMD, NEO:MMED) is on track for a late 2023 topline data readout for its Phase 2b trial evaluating its optimized form of LSD, MM-120, for generalized anxiety disorder.
As of May 2023, more than half of the target study population has been enrolled and dosed across 20 active clinical sites, the company reported.
Expected in the third quarter of 2023 are the results from Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED)'s Phase 1 pharmacokinetic clinical study of its proprietary stabilized psilocin analogue drug candidate L-130.
The study will evaluate the effect of a single oral dose in healthy volunteers to help determine the dose range of L-130 for a planned Phase 2 trial targeting the treatment of chronic cluster headaches.
Also expected in 3Q are initial results from Revive Therapeutics Ltd (CSE:RVV, OTCQB:RVVTF)’s study on oral psilocybin for methamphetamine use disorder.
The company said the data from the study may provide valuable information on the safety, efficacy, and dosing of oral psilocybin and, in turn, support research and commercial initiatives in countries like Australia where psilocybin will soon be able to be prescribed as a treatment for certain mental health conditions.
Further, in the second half of 2023, Numinus Wellness Inc. (TSX:NUMI, OTC:LKYSF) is expected to hand down the initial results from its Phase 1 clinical trial on experiential psychedelic-assisted therapy training using psilocybe cubensis tea.
As the first trial to study the safety and clinical efficacy of whole psilocybe mushrooms in their natural form, the data will be instrumental in expanding access to psilocybin-assisted therapies using psilocybe mushrooms.
Phase 3 COMP360 results eagerly anticipated
Looking ahead to 2024 and beyond, a key research program that is at the pivotal Phase 3 stage is London-based Compass Pathways (NASDAQ:CMPS) COMP360 psilocybin for treatment-resistant depression.
The company currently has two Phase 3 trials underway. Topline data from its single-dose monotherapy trial COMP 005 is expected in summer 2024, while topline data from its fixed repeat-dose monotherapy trial COMP 006 is set for mid-2025, Compass told investors in a corporate update in May.
Meanwhile, Mindset Pharma Inc (CSE:MSET, OTCQB:MSSTF) in June 2023 announced that it has received approval from United Kingdom regulators to conduct its first-in-human Phase 2 study involving its novel psilocin prodrug MSP-1014 in patients suffering from major depressive disorder.
While the company is yet to disclose a timeline for the trial, when available these results will certainly be of interest as preclinical studies comparing MSP-1014 to psilocybin demonstrated that MSP-1014 is just as effective as psilocybin in improving symptoms of depression while suggesting that it may be superior in terms of tolerability, according to Mindset.
Contact the author at emily.jarvie@proactiveinvestors.com
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