Mental health diagnoses, including depression, anxiety, post-traumatic stress disorder (PTSD), and addiction, are increasing in worldwide prevalence across all regions, ethnicities, religions, social circles, and education levels. Despite this trend, there has been a scarcity of newly developed therapeutics for these conditions with alternative mechanisms of action to treat the symptoms of disease or target disease reversal. Many traditional psychedelics have recently regained attention as potential therapeutic candidates for a myriad of mental health disorders. Years of scientific research has begun to elucidate their potential efficacy while anecdotal reports from recreational users have provided supporting evidence for the safety of these compounds in humans and suggest psychedelics may be potential alternative treatments for these conditions.

The two traditional methods for producing psychedelics, fungal-derived sources and chemical synthesis, have several limitations. Sourcing psychedelics from natural fungal sources is limited by availability of natural resources, long wait times for cultivated mushroom growth, natural abundance, inconsistent production due to environmental or other factors, and extraction difficulties. Traditional chemical synthesis, while capable of providing a high-quality, reproducible drug product, remains a low-yield, multiple synthetic and purification step, difficult-to-scale synthetic process utilizing expensive and frequently toxic reagents.

PsyBio Therapeutics, in collaboration with Miami University, has developed a psychedelic drug production platform that harnesses the biosynthetic ability of enzymes and the reproducibility and scalability of bioprocessing technology to enable the synthesis of diverse, bioactive tryptamines at industry leading titers, rates, and yields. At the center of this platform is a library of well-balanced and optimized bacterial strains expressing the core biosynthetic pathway genes from a psilocybin-producing mushroom. These highly active enzyme catalysts seamlessly combine with endogenous bacterial metabolism for precursor generation and cofactor recycle. Supplementation with any number of diverse starting materials provides the basis for biosynthesis of a wide array of natural and non-natural tryptamine drug candidates. These genetically elite strains, together with tailored bioprocessing methods, demonstrate production of gram-per-liter scale titers of multiple phosphorylated tryptamines (e.g., psilocybin) with negligible accumulation of the less stable, dephosphorylated degradation products (e.g., psilocin) through a single biotransformation step.

This core platform technology is now being leveraged to develop a wide range of alternative psilocybin derivatives, which hope to address the hallucinogenic side effects that limit full public acceptance and give this class of compounds a high regulatory burden in most locations around the world. To study the effects of these new or understudied drugs, PsyBio is also accelerating the preclinical study of select lead molecules produced by their biosynthetic platform. This work is targeted at developing an understanding of the mechanism of action surrounding the antidepressant, anxiolytic, and anti-PTSD properties of this powerful class of molecules as well as documenting dosing and dose-response mechanisms to inform future clinical studies. PsyBio Therapeutics is poised to fully develop a cost competitive solution for human clinical testing of these tryptamine therapeutic candidates as new chemical entities possessing key advantages over current in-clinic treatments for a range of mental health conditions impacting roughly 1 billion people globally.

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• Source: https://www.cell.com/trends/biotechnology/fulltext/S0167-7799(22)00311-0?rss=yes