XPhyto Therapeutics Corp (CSE:XPHY) (OTCMKTS:XPHYF) (FRA:4XT) has announced that its Good Manufacturing Practices (GMP) mescaline synthesis program is “on schedule” with the completion of initial production batches.
The industrial scale manufacture of pharma-grade psychedelic compounds, including mescaline and psilocybin, is a key part of XPhyto's psychedelic medicine program and will provide a plank for its drug formulation and clinical validation work.
Since launching its mescaline synthesis program in early 2021, XPhyto said it is “pleased” to be on schedule having completed lab set-up, preliminary synthesis, modified synthesis, and initial batch production.
The Vancouver-based bioscience accelerator is currently focused on the scale-up of production capability and the development of analytical methods and validation. “Development of standard operating procedures (SOP) for GMP certification of the synthesis process is also underway,” said the company.
"With both its North American GMP mescaline synthesis program and German-based psilocybin biotechnology production underway, the first stage of XPhyto's psychedelic medicine program is progressing on schedule. As the manufacturing programs advance, we look forward to focusing our expertise on psychedelic drug formulation," XPhyto CEO Hugh Rogers said in a statement.
"We see a significant market opportunity in the production of pharmaceutical-grade psychedelics followed by the standardization of dosage formulations with precise, predictable and efficient drug delivery for clinical study and therapeutic use," he added.
Psychedelic compounds have emerged as a new class of drugs with the potential to improve the treatment of mental health conditions like depression, anxiety, addiction, and trauma-related stress disorder.
Mescaline (3,4,5-trimethoxyphenethylamine) is a naturally occurring psychedelic compound found in certain cacti, such as peyote, and as recently reported in the publication 'ACS Pharmacology and Translational Science', naturalistic use of mescaline is associated with self-reported psychiatric improvements and enduring positive life changes.
“Of the respondents reporting histories of depression, anxiety, post-traumatic stress disorder (PTSD), and alcohol and drug use disorders (AUD and DUD), most (68-86%) reported subjective improvement following their most memorable mescaline experience,” according to ACS Pharmacology.
XPhyto’s GMP mescaline production program is carried out under contract by Applied Pharmaceutical Innovations (API), a not-for-profit institution at the University of Alberta, created to support translational drug development for industry. “All intellectual property is retained by XPhyto,” noted the company.
On November 3 last year, XPhyto sealed an agreement with a top German university for the exclusive development of a proprietary biotechnology process for the industrial manufacture of pharmaceutical-grade psilocybin.
XPhyto has R&D operations in North America and Europe. In Germany, in August 2019 - soon after going public - Xphyto acquired Vektor Pharma TF GmbH, which specializes in thin therapeutic films, such as skin patches and oral strips, and possesses a slate of narcotics licenses covering traditional and cannabis-related medications.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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