Since the pandemic, the prevalence of anxiety, depression and a sense of hopelessness has increased. Across countries, factors generally associated with financial insecurity, unemployment and atomization of society have had adverse physiological effects, prompting experts to ponder the dire consequences and their impact on the long-term health of the global economy. According to The National Institute of Mental Health, nearly one in five Americans suffer from some form of mental disorder.
Lancet Commission projects that the cost of mental disorders will reach $16 trillion by 2030, including lost productivity. The current approach to mental health has failed to deliver. Antidepressant medication sales in 2017 surpassed $14 billion, yet the alarming trends have only accelerated. As of 2018, nearly one in eight U.S adults use antidepressants.
In a 2020 study of adults with depression, Johns Hopkins Medicine researchers found that small doses of the psychedelic substance, combined with supportive psychotherapy, produced significant reductions in depressive symptoms, with most patients showing improvement, with half achieving remission through the four-week follow-up.
The psychedelic space is still in the infancy stage and has the potential to tackle various mental health issues, according to Bob Dagher, CMO of Florida-based Enveric Biosciences — which is developing next-generation, psychedelic-inspired mental health medicines.
Dagher believes Enveric Bioscience’s collaboration with the research team at the University of Calgary’s Hotchkiss Brain Institute is only the beginning of the partnership between academia and the Biotech industry, and no doubt will help demonstrate the potential benefits of these novel treatments.
Meanwhile, MindBio Therapeutics just completed the first phase of their research focused on LSD microdose therapy, which, for the first time, allowed participants to self-administer the drug at home. MindBio is on a mission to change mental health treatments and prevent suicide. The company’s Phase 1 clinical trials are aimed at researching psychedelics to find more effective treatments for depression and related conditions. The company has recently secured government funding of $1.44 million for LSD microdosing trials in major depressive disorder.
In Switzerland, Europe’s emerging hub for the life sciences industry, biopharma innovator Carvin Medicines is also looking at LSD’s impact as a mental health treatment, as well as its effect on extreme pain indications such as Fibromyalgia and Chronic Regional Pain Syndrome (CRPS).
However, investments are relatively scarce, considering the massive funding requirements for drugs to find their way into the market under the current conditions.
Silicon Valley legends like Peter Thiel, co-founder of PayPal, invested heavily in ATAI Life Sciences, another clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. According to the Guardian report, “in 2021 alone, 45 different investments led to a $595m windfall into the psychedelic medicine industry.”
But with the emergence of any new and disruptive market infidelity comes volatility and periods of uncertainty that test investors’ patience.
Ken Belotsky, partner at Negev Capital, a psychedelic medical intervention investment fund with $30 million under its management, thinks the market volatility and drop in valuation are part of the natural progression in this emerging industry. He believes that 90% of the companies in the psychedelic sector will disappear from the market; it’s a painful but essential part of the maturing process in any emerging space.
Another element to research development is the intersection of technology and the psychedelic industry. Enveric’s adoption of PsyAI technology is accelerating the development of optimized pharmaceutical candidates, each explicitly tailored for difficult-to-treat mental health indications.
Researchers at McGill University in Montreal use natural language processing, allowing voice assistants or search engines to study drug users’ experiences. According to MIT Technology Review, the work could shed light on “how hallucinogens trigger specific mental states, whether that be euphoria, anxiety, or a sense of being at one with the world.”
From a regulatory perspective, there’s also some considerable momentum.
In 2017, the U.S. Federal Drug Administration (FDA) categorized psychedelic-assisted treatments as “breakthrough therapy.” The designation process helps expedite the development and review of drugs that treat patients with severe or life-threatening conditions where clinical trials indicate the drug may demonstrate substantial improvement over other available therapies. Since then, health regulators in Canada and the U.S. have amended existing regulations to permit research on the efficacy of psychedelic drugs.
Last month, U.S. Senators Brian Schatz and Cory Booker called on the National Institutes of Health (NIH) and the FDA to conduct more research into the potential therapeutic uses of psychedelics.
Their letter stated, in part, that the “NIH and FDA are critical to ensuring a comprehensive, rigorous, and deliberative science-based approach to the study of psychedelics, including the potential development of medication and therapeutics derived from these substances.”
Regardless of the caveats, the research in psychedelic-therapy is incredibly promising and is helping to move the industry closer to expanding the available treatment options for patients with depression. In due course, other disorders, such as addiction or anxiety, may also show the utility of psilocybin-assisted therapy and rethinking mental health.
