XPhyto Therapeutics Corp. (CSE:XPHY, OTCQB:XPHYF) has given investors an update on the strong progress made by its wholly-owned subsidiary XPhyto Laboratories Inc’s psychedelic medicine programs in Canada’s Edmonton, which is focused on Good Manufacturing Practice (GMP) drug synthesis, drug delivery systems, psychedelic analogue engineering, and clinical validation.
The Vancouver and Germany-based bioscience accelerator first talked about its psychedelic medicine program in Canada. Through its exclusive contract research and development (R&D) collaboration with Applied Pharmaceutical Innovation, the group first announced on February 3, 2021, that XPhyto Labs is pursuing the application of psychedelic compounds to mental health-related conditions.
Based on a systematic literature review, the company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a range of mental disease such as depression, anxiety, post-traumatic stress disorder (PTSD), addiction and cluster headaches.
XPhyto and Applied have developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and approximately 60 gram (g) of GMP grade mescaline has been manufactured for clinical trial evaluation.
With mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side effects and provide precise dosage for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed through ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability.
That’s why the company is pursuing a novel drug delivery system designed to prevent these common negative side effects. However, due to sensitivity around intellectual property (IP), Xphyto said it could not disclose more details at this time.
In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel second generation psychedelic analogues. The group has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability.
XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a Phase I clinical trial in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system.
"We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization," said Professor Dr Raimar Löbenberg, who is a director at XPhyto. He is also the founder and director of the Drug Development and Innovation Centre, in the University of Alberta.
Dr Raimar Löbenberg added: "Our focus is to develop production methodology for GMP manufacturing, proprietary drug formulations with precise, predictable and efficient API delivery for clinical investigation and therapeutic use of novel next-generation psychedelic compounds."
Psychedelic medicine - Germany
In addition to operations in Canada and in collaboration with a major German university, the company is pursuing the development of industrial scale production methodology for GMP psilocybin through an advanced biosynthesis process focused on the insertion of genes from the psilocybin mushroom into certain bio-organisms.
The company noted that “gene insertion is complete and the micro-organisms are now producing psilocybin”. The company said it will share more details in due course.
XPhyto is a bioscience accelerator focused on next-generation drug delivery, diagnostic, and new active pharmaceutical ingredient investment opportunities. It has research and development operations in North America and Europe, with an operational focus in Germany.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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