PharmAla Biotech Holdings Inc, the biotech company producing MDXX class molecules has released a large-scale batch of its proprietary MDMA API, “Laneo,” becoming the first publicly-traded venture to produce the drug within Good Manufacturing Processes (GMP) in such a major amount.
While the other commercially-available source for this drug would be that of the Multidisciplinary Association for Psychedelic Studies (MAPS), PharmAla’s step point towards supporting clinical trial customers and partners in all parts of the world.
Now, PharmAla's LaNeo MDMA is set to be formulated by the company into a number of dosage forms, the first being a 40mg capsule, though it will also be available for pharmacists to compound directly where local regulations allow.
As stated by Parker Psychedelic Research’s incoming chair at the University of Calgary Dr. Leah Mayo: "Access to GMP research materials is often a rate liming step in clinical research; but now with greater access, the science will advance much faster, as will the potential for improving patient care."
PharmAla’s two major goals are offering generic MDMA for clinical trials and developing novel compounds in the universe of MDXX class molecules.
In this sense, the company has built what it believes to be North America's first GMP MDMA value chain, encompassing the GMP manufacturing of Active Pharmaceutical Ingredients (API) and drug product formulation.
Further, PharmAla's R&D division is currently engaged in preclinical research for two patented Novel Chemical Entities (NCEs) based on MDXX class molecules at the University of Arkansas School for Medical Sciences in the United States and at InterVivo Solutions in Canada.
"After a year of intensive work, we're thrilled to be able to announce this historic milestone for the company. As the only GMP MDMA manufacturer in the Americas, we're excited to do our part to alleviate the global backlog of clinical-grade MDMA," CEO Nick Kadysh said.
Kadysh is also chair of the board of Psychedelics Canada, a not-for-profit trade association representing Canadian psychedelic therapeutics and companies. Its board of directors also includes officers from companies Cybin, Psygen, EntheoTech BioScience, SABI Mind, and Absolem Health Corp.
"As research into MDMA dramatically increases and a number of countries begin to move to more permissive 'expanded access' regimes, PharmAla Biotech is perfectly positioned to continue to support scientific discovery by providing the clinical-grade drug product our research partners need," he concluded.
PharmAla’s COO Dr. Shane Morris explained: "Over the past 6 months, we've heard endlessly about the global supply chain crisis in psychedelic molecules. We're confident that, once researchers initiate clinical work with PharmAla's LaNeo MDMA, it will help drive interest in clinical trials for this impressive drug that several patient groups are urgently requesting."
Photo by CHUTTERSNAP on Unsplash
