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PharmAla Submits Pre-IND Dossier for Novel MDMA Analog to FDA

Last Updated on November 2, 2022 by GlobeNewsWire

VANCOUVER, British Columbia, Nov. 02, 2022 (GLOBE NEWSWIRE) — PharmAla Biotech (CSE:MDMA) is pleased to announce that it has submitted its pre-IND data meeting package to the US Food and Drug Administration (USFDA) in advance of its pre-IND meeting scheduled for later this month. PharmAla will be requesting FDA feedback on the nonclinical and CMC development plan to support the initial clinical trial for ALA-002.

“As a ‘regulatory-first’ organization, we know that regulators like FDA are rightly concerned with safety of novel medicines. One of the key goals for PharmAla was the development of MDXX compounds that show an improved safety profile compared to generic MDMA,” said Nick Kadysh, CEO of PharmAla Biotech. “We hope that USFDA will see the same potential in our pre-clinical results which we do.”

PharmAla’s goal is to bring ALA-002 into the clinic as a treatment for disorders in adults diagnosed with Autism Spectrum Disorder (ASD). As such, ALA-002 was tested not only in general population research, but also in generally accepted autism mouse models.

“ALA-002 is the first molecule of which we are bringing to USFDA, and we believe it will be an incredibly valuable tool to treat conditions commonly occurring alongside ASD,” said Dr. Harpreet Kaur, Vice President of Research for PharmAla Biotech. “However, we are hard at work identifying new molecules in the MDXX class that also have clinical promise. Using our proprietary MDXX drug discovery algorithm, we believe we will have even more molecules to bring to regulators in the near future – including the ABA series of non-controlled molecules.”

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 the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s 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. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. For more information, visit www.PharmAla.ca.

For more information, please contact:Nicholas KadyshChief Executive OfficerPharmAla Biotech Holdings Inc.Email: press@PharmAla.caPhone: 1-855-444-6362Website: 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 http://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.




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