PharmAla contracted Filament subsidiary Psilo Scientific to manufacture the drug product for distribution to clinical trial customers and authorized patients
Vancouver, British Columbia, April 11, 2023 – PharmAla Biotech Holdings Inc. (“PharmAla”) (CSE:MDMA), a Canadian biotechnology company dedicated to the research and development of clinical-grade LaNeo™ MDMA and novel MDXX compounds, and Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament”), a clinical-stage natural psychedelic drug development company, today announced the GMP release of MDMA capsules at the Metro Vancouver facility operated by Filament’s subsidiary Psilo Scientific.
“PharmAla has been working for some time to fill the backlog of MDMA for clinical researchers all over the world. As the psychedelics industry matures, the amount of clinical research for MDMA is set to grow,” said Nick Kadysh, CEO at PharmAla Biotech. “We’re happy to have reached this important milestone which will allow PharmAla to further distribute finished MDMA drug product to qualified researchers and are grateful to Filament for their partnership. Our eyes are now fully set on jurisdictions like Australia, which will require full commercial-scale manufacturing of both GMP API and drug product to fulfill demand for patients - and those jurisdictions still to come.”
Filament and PharmAla have entered into a partnership whereby Filament’s subsidiary Psilo Scientific was contracted to manufacture MDMA capsules for PharmAla, utilizing PharmAla’s previously-manufactured GMP LaNeo™MDMA Active Pharmaceutical Ingredient (API). The capsules are destined for distribution to clinical trial customers and authorized patients in Canada and globally. The MDMA was encapsulated at Psilo Scientific’s GMP-compliant, Health
Canada licensed facility.
“The GMP release of MDMA drug product is an exciting step for the psychedelic industry, and indicative of our manufacturing capability,” said Benjamin Lightburn, CEO and Co-Founder of Filament Health. “MDMA has shown promise for treating a range of health conditions and we’re proud to support PharmAla’s efforts to improve access.”
PharmAla will present its vision for the future of the commercial MDMA market at the Benzinga Psychedelics Capital Conference in Miami on April 13th.
PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. PharmAla has built what it believes to be North America’s first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO
press@pharmala.ca