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."

For more information, please visit www.PharmAla.ca, where you can sign up to receive regular new updates.

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 School for Medical Sciences in the United States and at InterVivo Solutions in Canada. For more information, visit www.PharmAla.ca.

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmAla's current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by PharmAla at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. The forward-looking information contained in this press release is made as of the date hereof, and PharmAla is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in PharmAla's management's discussion and analysis which is available on PharmAla's profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

SOURCE PharmAla Biotech Inc.

Nicholas Kadysh, Chief Executive Officer, PharmAla Biotech Holdings Inc., Email: [email protected], Phone: [phone], Website: www.PharmAla.ca