Press Release

PharmAla Biotech completes filing of patent application for 6 MDMA analogs

Patent application is evidence of PharmAla's success in developing safer MDMA-like drugs

VANCOUVER, BC, Aug. 29, 2022 /CNW/ - PharmAla Biotech (CSE: MDMA) is pleased to announce the filing of a key Patent Cooperation Treaty (PCT) application, containing 6 Novel Chemical Entities (NCEs). The application claims priority to, and benefit of a United States provisional patent application filed August 20, 2021. This PCT application disclosed novel compositions of MDMA and analogs thereof which may be used to alleviate the known side effects of MDMA while retaining its efficacy.

Building on preclinical animal studies completed at the University of Arkansas School for Medical Sciences (UAMS), PharmAla has developed compelling evidence of the improved safety pharmacology of its ALA series of MDMA Analogs; This includes evidence of diminishing hyperthermia and neuro- and cardio-toxicity, while retaining its therapeutic effects. The ALA series is composed of 3 distinct NCEs, although PharmAla expects to bring only one of these molecules to IND status at this time.

"MDMA is a fascinating molecule with a troubled history. The therapeutic potential of this compound has been obvious since its earliest days, but its potential for abuse and adverse effects has been just as noteworthy. The work being done at PharmAla to create formulations which retain therapeutic efficacy while minimizing harm is incredibly important to the future of MDMA as a medicinal agent, and the drug development strategy their work exemplified through this patent is a model for the field of 'psychedelic medicine' as a whole," said Dr. William Fantegrossi, Principal Investigator for PharmAla Biotech at UAMS.

PharmAla's research into its ABA series of molecules, which are comprised of an MDMA analog not currently listed as a controlled substance in Canada, is also contained within the patent filing. PharmAla expects to bring one of its 3 ABA NCEs to trial in an ex-USA jurisdiction, where its status as a non-controlled substance will allow for faster and more cost-effective research.

"Addressing the toxicology of generic MDMA with the aid of novel compositions and new drug molecules has been the primary focus of our work. This patent application reinforces our position in the industry as the pioneers of MDMA development. Considering we're the only public company to have manufactured GMP MDMA, that's only fitting," said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. "There is a serious unmet need for patients with mental health challenges. Psychedelics continue to demonstrate their benefits through multiple clinical trials. However, as a 'regulatory first' company, we know that both regulators and the general public demand exemplary safety from pharmaceutical products such as MDMA; This patent represents our first step to meeting that high bar."

About PharmAla

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.

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