Patent application is proof of PharmAla’s success in developing safer MDMA-like drugs

VANCOUVER, BC, August 29, 2022 /CNW/ – PharmAla Biotech (CSE: MDMA) is pleased to announce the filing of a key patent cooperation treaty (PCT) application containing 6 new chemical entities (NCEs). The application claims priority and the benefit of a United States provisional patent application filed August 20, 2021. This PCT application describes novel compositions of MDMA and analogs thereof that can be used to alleviate the known side effects of MDMA while maintaining its effectiveness.

Based on preclinical animal studies carried out at University of Arkansas School for Medical Sciences (UAMS), PharmAla has developed compelling evidence for improved safety pharmacology of its ALA series of MDMA analogues; This includes evidence of decreased hyperthermia and neurotoxicity and cardiotoxicity, while retaining its therapeutic effects. The ALA series is made up of 3 distinct NCEs, although PharmAla expects only one of these molecules to achieve IND status at this time.

“MDMA is a fascinating molecule with a troubled history. The therapeutic potential of this compound has been evident since its inception, but its potential for abuse and adverse effects is equally remarkable. The work done at PharmAla to create formulations that retain therapeutic efficacy while minimizing harm is extremely important to the future of MDMA as a medicinal agent, and the drug development strategy their work illustrates through this patent is a model for the field of “psychedelic medicine” as a whole,” said Dr. Guillaume FantegrossiPrincipal Investigator for PharmAla Biotech at UAMS.

PharmAla’s research on its series of ABA molecules, composed of an analog of MDMA that is not currently listed as a controlled substance in Canada, also appears in the patent filing. PharmAla plans to take one of its 3 ABA RCEs to court in a formerUNITED STATES jurisdiction, where its non-controlled substance status will allow faster and more cost-effective research.

“Addressing the toxicology of generic MDMA using new compositions and drug molecules has been the primary focus of our work. This patent application furthers our position in the industry as pioneers in the development of MDMA Since we are the only public company to have manufactured MDMA GMP, this is completely normal,” said Dr. Harpreet Kaur, vice president of research at PharmAla Biotech. “There is a serious unmet need for patients with mental health issues. Psychedelics continue to demonstrate their benefits through multiple clinical trials. However, as a ‘regulatory first’ company, we know that regulators and the general public demand exemplary safety from pharmaceuticals such as MDMA, and this patent represents our first step in reaching that high bar.”

For more information, please visit www.PharmAla.cawhere 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 purpose: to reduce the global backlog of clinical-grade generic MDMA to enable clinical trials and to develop new drugs in the same class. PharmAla is a “regulatory first” organization, formed on 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 first cGMP MDMA value chain, encompassing GMP manufacturing of active pharmaceutical ingredients (APIs) and formulation of pharmaceutical products. PharmAla’s research and development unit has also begun preclinical research on two patented New Chemical Entities (NCEs) based on MDXX-class molecules, with proof-of-concept research currently underway at University of Arkansas School of Medical Sciences of 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 has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Caution

This press release contains “forward-looking information” within the meaning of applicable Canadian securities laws. These statements relate to future events or future performance. Use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “plan”, “estimate” 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 beliefs 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 as of the date of the information and is subject to known and unknown risks, uncertainties and other factors that may cause actual results or events 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 undertakes no obligation 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 “Risk Factors” in PharmAla’s MD&A which is available on PharmAla’s profile at www. .sedar.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, and does 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.

For further information: Nicholas Kadysh, President and CEO, PharmAla Biotech Holdings Inc., Email: [email protected]Phone: 1-855-444-6362, Website: www.PharmAla.ca