PharmAla Comments on USFDA Decision regarding MDMA-Assisted Therapy and Announces Patent Granting for ALA-002

Rhea-AI Summary

PharmAla Biotech Holdings Inc. (CSE: MDMA) (OTC:MDXXF) has responded to the USFDA's decision to request a third confirmatory Phase 3 trial for MDMA-assisted therapy in treating PTSD. While disappointed, PharmAla's CEO Nicholas Kadysh emphasized the company's US operations and commitment to ongoing research. PharmAla currently supplies LaNeo™ MDMA for patient treatments in Canada and Australia under special access programs.

Additionally, PharmAla announced the USPTO issuance of patent No. 12,053,452 for ALA-002, its novel non-racemic mixture of MDMA enantiomers. This patent is seen as a valuable asset in PharmAla's R&D program, addressing safety concerns associated with racemic MDMA and potentially positioning ALA-002 favorably for regulatory approval.

Positive

• Patent granted for ALA-002, a novel non-racemic mixture of MDMA enantiomers
• Current supply of LaNeo™ MDMA for patient treatments in Canada and Australia
• Contracted supplier for over a dozen human clinical trials globally
• Preclinical research shows ALA-002 addresses safety concerns of racemic MDMA

Negative

• USFDA request for additional Phase 3 trial delays potential US market entry
• operations in the US market

TORONTO, Aug. 09, 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 disappointed in the decision made by the US Food and Drug Administration (USFDA) to request that Lykos Therapeutics complete a third confirmatory Phase 3 trial prior to allowing the approval of MDMA assisted therapy (MDMA-AT) for the treatment of Post Traumatic Stress Disorder.

“PharmAla does not operate in the US except as a clinical trial supplier, and as such this decision will have a limited impact on our operations in the near-term. USFDA has an important responsibility to get things right, and we believe that they are acting in good faith, however there is a vitally important patient need for novel PTSD treatments which must be balanced with that prudency,” said Nicholas Kadysh, CEO, PharmAla Biotech. “MDMA is not only supported by a significant evidence base of published clinical trial research, but is also being actively used in patient treatments in 2 jurisdictions, Canada and Australia, entirely supplied by PharmAla. There is a growing body of evidence of its efficacy in the real world, to which we are pleased to have contributed. We must re-commit ourselves to ongoing research which will convince even the most sceptical regulators that this medicine is both safe and effective.”

PharmAla produces its LaNeo MDMA capsules in Canada, under GMP conditions. They are distributed in Canada under the Health Canada Special Access Program, to qualified patients, and in Australia under the Therapeutic Goods Administration (TGA)’s Authorized Prescriber Scheme. In Australia, distribution and sales are performed by Cortexa, PharmAla’s Joint Venture (JV) with Vitura Ltd.

“As a result of this decision, we anticipate clinical research on MDMA to increase; PharmAla is an important supplier of MDMA for that research, with over a dozen human clinical trials contracted globally, and we will continue to support our partners in their efforts,” said Dr. Shane Morris, COO, PharmAla Biotech.

ALA-002 Patent Issuance

PharmAla is pleased to announce that its patent for the composition of matter for its novel, non-racemic mixture of MDMA enantiomers, internally deemed ALA-002, has been issued by the US Patent and Trademark Office (USPTO), under patent No. 12,053,452.

“We believe that the issuance of this patent represents an incredibly valuable cornerstone of PharmAla’s research and development program. Numerous researchers have indicated concern with several elements of racemic MDMA, including both acute and chronic cardiotoxicology, as well as adverse events such as hyperthermia,” said Dr. Harpreet Kaur, VP of Research, PharmAla Biotech. “Our preclinical research, now published, has proven that we have significantly addressed these concerns. By addressing these safety issues, we believe that PharmAla’s ALA-002 development program is exceptionally positioned to gain favourable approval by regulators.”

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.

FAQ

What is the current status of MDMA-assisted therapy approval by the USFDA for PTSD treatment?

The USFDA has requested a third confirmatory Phase 3 trial before considering approval of MDMA-assisted therapy for PTSD treatment, delaying potential market entry in the US.

Where is PharmAla Biotech (MDXXF) currently supplying its LaNeo™ MDMA for patient treatments?

PharmAla is currently supplying LaNeo™ MDMA for patient treatments in Canada under the Health Canada Special Access Program and in Australia under the TGA's Authorized Prescriber Scheme.

What patent did PharmAla Biotech (MDXXF) recently receive from the USPTO?

PharmAla received USPTO patent No. 12,053,452 for ALA-002, its novel non-racemic mixture of MDMA enantiomers, which addresses safety concerns associated with racemic MDMA.

How many human clinical trials is PharmAla Biotech (MDXXF) currently supplying MDMA for?

PharmAla is currently contracted to supply MDMA for over a dozen human clinical trials globally.