Patent Allowance Granted for ALA-002 Composition by US Patent and Trademark Office

Novel Composition of MDMA Enantiomers leading to next-generation MDMA possibilities

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) — PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is extremely pleased to announce that the US Patent and Trademark Office (USPTO) has indicated it is issuing an allowance for the granting of a patent for ALA-002, the company’s lead investigational MDXX Novel Chemical Entity (NCE). This provides the Company a strong basis for ongoing protection of this intellectual property (IP).

ALA-002 is a novel mixture of MDMA enantiomers, consisting of 70-80% R-MDMA and 20-30% S-MDMA. Preclinical testing has shown that the administration of ALA-002 results in significantly lowered incidence of hyperthermia, the major adverse event elicited by racemic generic MDMA. The Composition also showed improved indication of pro-social effect in both C57 (General Population) and BTBR (Autism-Like) mouse models, and a reduced “abuse liability” (addiction) potential.

PharmAla’s patent application included in-vivo experimental animal data, which is generally held to be stronger evidence than computational, or in-silico, modeling.

“MDMA is relatively unique in that it has two enantiomers that are active, but are active in dramatically different ways. In the brain, these two variants of the molecule have a synergistic effect. In short, the sum of these parts is greater than the whole,” said Dr. Harpreet Kaur, Vice President of Research at PharmAla Biotech. “Viewed this way, it becomes obvious that the effects of racemic MDMA should be viewed not as one active, but as a combination effect – and as such, it is open to optimization. With ALA-002, we believe we have done that difficult work, and have created an improved, novel, next generation MDMA drug substance formulation.”

ALA-002 is considered by the US Food and Drug Administration (FDA) to be a Novel Chemical Entity (NCE), and in the opinion of the Company it is a different Active Moiety than racemic MDMA. As such, the Company believes that should it be approved by the FDA for use as a treatment for any disorder, it should be granted its own Data Exclusivity period.

The Company intends to pursue its own clinical research with the novel composition, either alone or with an out-licensing partner. It has completed a Phase 2 protocol for the research of ALA-002 as a treatment for Social Anxiety symptoms in patients with Autism Spectrum Disorder (ASD) in conjunction with researchers at the University of Sydney. The Company believes that this is an Orphan Indication, in that there are no FDA-approved treatments currently available for social anxiety in autistic patients. However, the Company also believes that ALA-002 could be useful in the treatment of a number of neurological and neuropsychiatric disorders.

“We are incredibly pleased that USPTO has issued an allowance for the granting of the Composition of Matter patent for ALA-002. This is the culmination of years of pre-clinical and intellectual property work, and represents a significant achievement in a relatively crowded IP environment,” said Nick Kadysh, Founding CEO, PharmAla Biotech. “PharmAla’s IP team has already begun working towards patenting this composition in a number of relevant global markets, with the support of Intellectual Property Ontario (IPON), and we are excited to both defend and build on what we believe is an exceptionally valuable piece of intellectual property.”

PharmAla intends to use this landmark USPTO allowance to accelerate allowance in other jurisdictions through all practicable means.

About PharmAla

PharmAla Biotech Holdings Inc. (CSE: MDMA)(OTCQB: MDXXF) 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 as well as commercial sales in selected jurisdictions, and to develop novel drugs in the same class. PharmAla is the only company currently provisioning clinical-grade MDMA for patient treatments outside of clinical trials. PharmAla’s research and development unit has completed proof-of-concept research into several IP families, including ALA-002, its lead drug candidate. 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.

For more information, please contact:
Nicholas Kadysh
Chief Executive Officer
PharmAla Biotech Holdings Inc.
Email: press@PharmAla.ca
Phone: 1-855-444-6362
Website: 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