Labiotech had the opportunity to ask James Kuo, vice president of R&D at Silo Pharma Inc., about his predictions for the field of psychedelic research in 2023.\n\n\n\nSilo Pharma is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Alzheimer’s disease, and other rare neurological disorders. \n\n\n\nWhat breakthroughs do you foresee in psychedelic research in 2023?\n\n\n\nWe should expect to see a multitude of mid and late-stage clinical trial readouts in 2023. The indications include treatment resistant depression, PTSD, generalized anxiety disorder, and alcohol use disorder. The drug candidates are psilocybin, MDMA, LSD, DMT, and ketamine. \n\n\n\nIf earlier phase 2 clinical trial results are predictive of the outcome in these larger trials, positive results should be expected. Psychedelic research is not a single shot on goal but many indications and a plethora of psychoactive or dissociative drugs. Lots of funding poured into the sector in 2019, 2020 and even 2021 so these leading psychedelic companies should be quite capable of funding these clinical trials to completion. Breakthrough status should be accorded, which currently are devoid of safe and effective therapies. \n\n\n\nHow will the recession impact the biotech industry, specifically in psychedelic research in 2023?\n\n\n\nIt was “the best of times, the worst of times.” So wrote Charles Dickens in A Tale of Two Cities. Certainly, that phrase can be applied to psychedelic research. \n\n\n\nThe macro recession spurred by global inflation, covid, military conflict in Europe and supply chain issues, has certainly affected not just the overall economy but spilled over to the biotech industry, and in particular psychedelic research. \n\n\n\nComing off a particularly strong funding environment in 2020 for psychedelic companies, their fall has been more precipitous as many companies seemed to lack the financial discipline to tack their operations to a de minimis funding climate. In addition, some of their business models were highly unsustainable and a lack of ironclad IP protection has always loomed over the sector. \n\n\n\nThe furnace of capitalism has always proven highly efficient in redistributing capital to the winners in a power hierarchy. Inevitably, that will occur among psychedelic companies. M&A will take place at an accelerated pace. Like a wildfire that burns through a forest, those that survive will stoutly grow in an ecological niche devoid of their former competition--fertilized by the ashes of their fallen peers.\n\n\n\nPsychedelic therapies have recently been widely proven and accepted for the treatment of psychiatric disorders. What other areas of medical concern can benefit from psychedelics that are to come?\n\n\n\nThe brain is said by some to be the final frontier. While many look outward to space for exploration and discovery, others peer inward to our brain to understand how it truly functions--or doesn’t. \n\n\n\nAs the most complex structure in the universe, even a basic understanding of common processes such as consciousness and sleep elude us. Brain pathologies such as chronic pain, addictive behavior, depression, anxiety, psychoses, and neurodegeneration loom as challenging conditions to develop safe and effective therapies. \n\n\n\nThe pharmaceutical approach to brain diseases applied a classical inhibition of a receptor or enzyme methodology or modulating a neurotransmitter. While leading to modestly effective therapies that benefited a minority of patients, clearly there is an undiscovered continent to explore. \n\n\n\nPsychedelics are fascinating in that they posit a new mechanism for brain disease thought to be regressing it to a more immature state when greater plasticity is possible. Thus while the brain is a literal neural network, rewiring this electrical supercomputer seems a high feasible and new mechanism of cognitive advancement. \n\n\n\nWhat technologies do you foresee will help overcome challenges in recruitment and trial efficiency?\n\n\n\nAs a society, we are inevitably transitioning to social media and mobile telecommunications and that certainly will be reflected in clinical trial recruitment and assessing clinical trial benefits and safety. These technologies will translate to more efficient clinical trials manifested by quicker timelines to completion and reduced cost structures.\n\n\n\nWhat regulatory developments do you foresee necessary to help implement psychedelics in traditional therapies?\n\n\n\nIn the United States and most Western countries, the daily practices of law enforcement are highly influenced by the will of the population and the relative risk of negative social outcomes. That being said, it is clear that the majority of the people in many states agree that psychedelic therapies are worthwhile and not to be impeded. Accordingly, I see little or no Federal impediment to legitimate scientific research of psychedelics or their commercial use once FDA approval is gained. \n\n\n\nAbsent a major incident(s), the Drug Enforcement Agency is highly likely to allow the FDA to manage the use of psychedelics. As may be self-evident, the FDA is a science-driven agency examining data on adverse effects and abuse. When necessary, they mandate a drug sponsor a Risk Evaluation and Mitigation Strategy.\n\n\n\nHow will different geographies affect psychedelic regulation and implementation?\n\n\n\nStates populated by citizens that allow and accept psychedelic research will figure prominently in clinical trials for many reasons. A primary one is rapid recruitment of patients. A populace that believes they are likely to benefit from a randomized clinical trial are more inclined to enroll in them. \n\n\n\nReducing the time from initiation of a clinical trial to complete enrollment can significantly reduce study cost. Among the states that favor psychedelic legalization are California, Colorado and Oregon.