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Late last month, the US Food and Drug Administration (FDA) set forth guidance for drug trials on hallucinatory compounds like LSD or psilocybin, as well as other so-called psychedelic drugs like ketamine or MDMA, for the first time. A growing body of research on these treatments is already well-established, focusing on the treatment of post-traumatic stress disorder, depression and other mental health conditions, but these new guidelines will “help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” according to Tiffany Farchione, director of the FDA’s Division of Psychiatry. A 60-day public comment period is open for interested parties to submit feedback on how final guidance should be further shaped.
Clinical trials of compounds like psilocybin have yielded plenty of impressive results over the past several years, and those findings can now be molded into proper conformity with FDA guidance to bolster commercialization efforts. In January, MRP noted that a successful phase 2B trial of psilocybin sponsored by COMPASS Pathways PLC, a mental health care company focused on the use of innovative therapies to treat depression, and published in The New England Journal of Medicine, would soon expand into the world’s first phase 3 trial of the compound, which will include two clinical trials, testing of multiple dosages instead of a single dose, as well as a long-term follow-up that could enroll nearly 1,000 patients. In phase 2B, results showed that patients who received a single dose of 25mg COMP360 psilocybin experienced a highly statistically and clinically significant rapid reduction in symptoms of depression compared to 1mg at 3 weeks. The trial, which included 233 people with treatment-resistant depression (TRD) across 10 countries, found 37% of people with TRD in the 25mg group met criteria for response at week 3 (≥50% decrease in depressive symptoms). More significantly, ScienceDaily notes that 20% met the criteria for sustained response at week 12.
The phase 3 program, which includes two separate trials (COMP 005, COMP 006), is now underway, with FDA feedback and hopes of replicating Phase 2’s positive results. The COMP 005 trial aims to compare a single 25mg dose of COMP360 synthetic psilocybin paired with psychological support to a placebo, with top line data expected by next summer. COMP 006 will likely take longer, with top line data expected around mid-2025. In the latter trial, subjects will receive COMP360 25mg, 10mg, or 1mg with the objective to examine whether a second dose can increase the number of people with positive response to psilocybin therapy or improve the response observed in the Phase 2B study. Speaking at the July 6 PSYCH Symposium in London, COMPASS Pathways representatives reportedly indicated that psilocybin therapy may start to achieve commercialization “by the beginning of 2027”.
Marijuana Moment notes that lawmakers across both major US parties responded positively to the FDA’s recent actions, with US Representatives Dan Crenshaw (R-TX), Mariannette Miller-Meeks (R-IA) and Ro Khanna (D-CA) having just requested FDA guidance for psychedelics research days prior to it being released. The support of federal lawmakers will be critical in bringing psychedelics to market as all the major compounds that are likely to be used in potential treatments are subject to federal prohibition and are listed on the US Drug Enforcement Administration’s (DEA) list of controlled substances. That continues to be a major deterrent to the growth of the American cannabis industry, particularly in regards to banking, despite recreational and/or medicinal marijuana being legal to possess and distribute in 38 of the US’s 50 states.
As far as legislators’ constituents go, more Americans appear to be in favor of the abolition of psychedelic therapies than against. A poll from the University of California, Berkeley Center for the Science of Psychedelics (BCSP) shows “More than six out of 10 (61%) American registered voters support legalizing regulated therapeutic access to psychedelics, including 35% who report ‘strong’ support… In addition, more than three-quarters of voters (78%) support making it easier for researchers to study psychedelic substances. Almost half (49%) support removing criminal penalties for personal use and possession.” Full results of this poll will be released later today and MRP will continue to analyze the trends observed in the polling data.
A shift can also be detected among institutional investors, where interest in psychedelics is spiking – but skepticism may still drag on inflows into the industry. BioWorld reports that a survey of 104 financial services firms on both sides of the Atlantic shows all but 6% have an interest in psychedelic medicines. However, only 23% say they are “very likely” to invest in the sector in the future. The attitude of those in finance will obviously be key to the growth of psychedelics, as future funding rounds will be essential to sustaining the potential manufacturers and distributors that have already entered the market, as well as establishing new entrants.
Several publicly traded entities in the psychedelics industry, including Mind Medicine (MindMed) Inc. (MNMD), COMPASS Pathways plc (CMPS), Atai Life Sciences (ATAI), and Cybin Inc. (CYBN), were slammed throughout the course of 2021-2022, but most of those have posted more positive performance in throughout 2023.
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