PsyBio Therapeutics Corp (CVE:PSYB) announced Tuesday that it has initiated a pilot scale-up of its proprietary biosynthetic formulation of psilocybin in collaboration with Albany Molecular Research Inc.
The company said it has completed Phase I of this process, including technology transfer activities, preparation of strain banks, and the adoption of analytical methods while looking forward to communicating additional progress.
“We are pleased to have moved our first production process from the laboratories of Dr. J. Andrew Jones at Miami University to a commercial development facility to scale production of our proprietary biosynthetic psilocybin ahead of clinical trials,” said PsyBio CEO Evan Levine in a statement.
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“Our proprietary platform technology allows our Company to generate high concentrations of psilocybin without needing to incorporate the actual fungus or rely on toxic and costly chemical synthesis reagents. Our methods to produce psilocybin and other tryptamines are expected to result in cheaper, faster and cleaner products than any other published methods,” Levine added.
PsyBio said that pharmaceutical grade psilocybin is currently being produced for clinical trials and research activities using a chemical synthesis process with reagents such as heavy metal catalysts and toxic solvents that creates multiple unstable reaction intermediates and undergoes numerous purification steps resulting in low carbon yield. This long reaction scheme takes about 5 to 15 days.
The company also noted that the published literature on this process also states that the active pharmaceutical ingredient costs about US$2,000 per gram and attempting to purchase research-grade psilocybin garners prices between US$7,000 to US$10,000 per gram.
PsyBio said it has developed a biosynthetic process using readily available materials, which undergoes a two- to four-day, one-pot autocatalytic process. The result is a product with high-temperature stability, and the pre-purified material currently costs approximately US$10 per gram to produce.
Dr Jones, chairman of the company’s Scientific Advisory Board, added: “I’m excited to see one of my lab’s discoveries moving towards commercialization. Our talented team’s unwavering commitment has continued to energize us to reach this significant milestone on our way to developing a transformative potential therapy for millions of patients worldwide.”
PsyBio said the underlying technology was developed at Miami University by a team led by Dr Jones, a faculty member in the Department of Chemical, Paper, and Biomedical Engineering. The technology is expected to enable the sustainable production of promising tryptamine drug candidates by fermentation of genetically engineered bacteria and is exclusively licensed to PsyBio on a worldwide, exclusive, and perpetual basis.
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