PharmAla, the world’s first publicly-traded manufacturer of GMP MDMA, has contracted with Clerkenwell Health, a UK-based CRO and Clinical Trial site, to provide regulatory support for both US FDA and UK MHRA applications
VANCOUVER, October 11, 2022 (Canada Newswire) – PharmAla Biotech (CSE:MDMA) is pleased to announce that it has retained Clerkenwell Health, a UK- based Contract Research Organization, to assist PharmAla in regulatory proceedings with both the US Food and Drug Administration (FDA) and the UK Medicines and Health Regulatory Authority (MHRA). PharmAla intends to bring ALA-002, its leading Novel Chemical Entity (NCE), to both jurisdictions. ALA-002 was designed to provide the same efficacy as MDMA, has an improved safety profile, including Cardio- and Neuro-tox, and fewer adverse events.
“PharmAla have a unique and exciting strategy, which could present real improvements to clinical development and application of empathogens” said Dr Henry Fisher, Co-founder and Chief Scientific Officer at Clerkenwell Health. “Engaging with both the MHRA and the FDA on their behalf is also an important milestone for us as we widen our clinical research footprint.”
Clerkenwell will provide regulatory support for ALA-002 in both the UK and USA. The agreement also countenances the potential to drive more molecules through the pharmaceutical regulatory approvals pathway. PharmAla continues to develop additional molecules, including its ABA series of non-controlled MDMA analogues, and further NCEs still under development.
"Clerkenwell represents an excellent partner to push forward our regulatory efforts," said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “They have brought not only excellent experience with regulatory affairs in two different key jurisdictions, but also represent the capability to execute clinical research at their UK facility. We’re incredibly pleased to have them as partners.”
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