In what it is calling a milestone in psychedelics research and development, MGC Pharmaceuticals Ltd (LSE:MXC, OTC:MGCLF, ASX:MXC) has been granted its first import permit for 200 grams of psilocybin raw mushroom material to its Slovenian research facility.
Significant step forward
This development marks a significant step forward for both MGC Pharma and for the study of therapeutic applications of psilocybin generally.
The import permit was issued as part of a material transfer agreement between MGC Pharma and Psyence Group Inc, a prominent life science biotechnology company focused on natural psychedelics.
The material will be sourced from Psyence's Southern Africa production site, which is one of the world's first federally licensed commercial psilocybin mushroom cultivation and production facilities.
As per the agreement, MGC Pharma will conduct a thorough analysis of the Psilocybin Raw Mushroom material, to support Psyence in developing new psilocybin products for the market.
MGC Pharma's Slovenian research facility, which recently obtained approval for psilocybin compounding, is GMP-certified, which will ensure high-quality research and development processes.
Naturally occurring in fungi
Psilocybin is a naturally occurring psychedelic prodrug compound found in more than 200 species of fungi. Psyence focuses on using natural psilocybin products for the healing of psychological trauma and its mental health consequences, with a particular emphasis on palliative care.
The collaboration between MGC Pharma and Psyence has been characterised by rigorous evaluations to meet stringent industry standards. MGC Pharma conducted a successful audit of Psyence's production site, ensuring that it adheres to the necessary protocols and requirements for exporting psilocybin to MGC's European facilities. Following this audit, the import approval for psilocybin was granted.
Once Psyence completes the export process on receipt of the export permit, MGC Pharma will kick off its analytical findings and technical evaluation of the initial 200-gram psilocybin raw mushroom shipment.
Based on its findings, the company will develop analytical methods and stability testing in compliance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Entry into psilocybin market
MGC CEO and managing director Roby Zomer said: “We are delighted to receive the first import approval of psilocybin under our collaboration with Psyence, which constitutes our first entry into the psilocybin market.
“This partnership marks a significant milestone for MGC Pharma following our recent approval for psilocybin research in our Slovenian facility and reinforces our commitment to growth and innovation.
“By joining forces with Psyence, we are combining our respective strengths and expertise to unlock new opportunities and deliver exceptional value to our customers. This collaboration enhances our ambitions to be one of the first companies to provide psilocybin treatments alongside our plant-based treatments.”