PsyBio Therapeutics Corp (CVE:PSYB) (OTCMKTS:PSYBF) (FRA:PSYB) announced it is starting to manufacture proprietary biosynthetic psychedelic compounds in Europe.
The initial pilot-scale batch manufacturing run is the Florida-based company’s first in the continent, it said in a statement.
PsyBio is working with France’s Biose Industrie, which commercializes pharmaceutical products based on live bacterial production, to help prepare the products and substances for regulatory evaluation.
READ: PsyBio Therapeutics ends 1Q with C$13M in cash, announces psychedelic webinar from CEO Evan Levine
In a statement, PsyBio’s chief medical officer Michael Spigarelli told investors that it was “critically important” for the company to leverage its proprietary methods of production within the European Union.
“Biose is the ideal partner for us in the EU with extensive expertise and capability to not only produce individual therapies in a regulatorily-compliant manner, but to also facilitate the development and testing of combination therapies,” Spigarelli said.
“Our partnership with Biose will further our research and development goals and demonstrate our commitment to the development of globally-tested and approved therapeutics.”
Biose has over 70 years of experience in commercializing therapeutics from live bacterial strains.
"In our effort to expand our clinical development beyond North America, we are pleased to be working with Biose, a highly competent company operating under a Good Manufacturing Practices-certified facility located in Aurillac, France, for the manufacturing of our bacteria-based drug substance and drug products in the European Union for further pre-clinical and clinical scientific evaluation," said Evan Levine, PsyBio’s CEO.
PsyBio researches and develops novel formulations of psychoactive medications produced from genetically-modified bacteria to treat mental health conditions.
Separately, the company said it had settled US$125,144.48 of accrued liabilities owing for professional services provided to the company by a non-arm's length party through the issuance of 409,752 subordinate voting shares priced at C$0.37.
PsyBio also said it had hired marketing firm North Equities Corp for investor awareness activities in a six-month consulting agreement worth C$70,000 in cash.
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