PharmAla's GMP MDMA will accelerate trial work funded by Australia's premier Psychedelics charity
VANCOUVER, BC, April 8, 2022 /CNW/ - PharmAla Biotech is proud to have been selected as the MDMA manufacturing partner for Mind Medicine Australia. Mind Medicine Australia's order will be available for delivery later this year, for use in an ethics approved healthy persons trial and will be subject to all necessary government approvals being obtained.
"We'd like to congratulate Nick and his team for the ground-breaking work that they have done in developing GMP, medical grade MDMA for use in clinical trials and regulatory approved expanded access schemes," said Peter Hunt, Board Chair of Mind Medicine Australia. "There is a desperate need for innovation in the mental health sector for hard-to-treat illnesses such as post-traumatic stress disorder which cause enormous suffering. Clinical trials have shown that MDMA assisted therapy is safe to use in clinically controlled environments and can achieve high remission rates for people suffering from post-traumatic stress disorder".
Mind Medicine Australia is a registered charity founded by Tania de Jong AM and Peter Hunt AM in 2019. Mind Medicine Australia supports clinical research and is working towards regulatory-approved and evidence-based psychedelic-assisted therapies being available through the medical system in Australia for patients suffering from relevant treatment resistant mental illnesses including depression and post-traumatic stress disorder. Mind Medicine Australia connects medical practitioners, consumers, academia, government, industry, regulatory bodies, philanthropists, investors and other stakeholders and provides therapist training and clinical support for psychedelic assisted therapies through its Mind Medicine Institute. Mind Medicine Australia is focused specifically on the clinical application of regulatory approved medicinal psilocybin and medicinal MDMA assisted therapies for certain mental illnesses; its focus is entirely clinical in nature.
"PharmAla is currently the only company in North America which has completed a full GMP value chain for MDMA. We're so excited to be able to advance the work of Mind Medicine Australia, an organization which I have long admired for both their scientific rigour and advocacy efforts," said Nick Kadysh, PharmAla's CEO. "I know that these research materials will be put to good use, healing people and generating the data which Mind Medicine will use in their continuing efforts to legalize and destigmatize MDMA and other psychedelic-based treatments."
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