PharmAla to supply STRONG STAR at UT Health San Antonio, with novel dosage form of LaNeo™ MDMA

Rhea-AI Summary

PharmAla Biotech Holdings (OTC:MDXXF) has announced advancement of its contract with UT Health San Antonio for the STRONG STAR Consortium study, funded through the Defense Appropriations Act. The company will develop a new 20mg clinical drug product dose of its LaNeo™ MDMA, complementing its existing 40mg capsules.

The Department of Defense-funded project, valued at $10M, will examine MDMA-Assisted Therapy (MDMA-AT) effects on active-duty military personnel with PTSD. The study will be conducted at two sites: UT Health San Antonio and Emory University. This development will allow greater dosing flexibility for clinical trials and eventual patient treatment in jurisdictions where permitted.

Positive

• DoD grant funding secured for clinical trials
• Development of new 20mg dosage form expanding product line
• Strategic entry into military PTSD treatment market

Negative

• None.

TORONTO, Feb. 27, 2025 (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 proud to announce that its previously announced (See press release of October 8, 2024) contract to the University of Texas Health Science Center at San Antonio (UT Health San Antonio) will move forward, with the trial having been funded by a grant via the Defense Appropriations Act.

“This DoD-funded project has the potential to be a game-changer for the treatment of PTSD in active duty military populations,” said Alan Peterson, PhD, professor of psychiatry and behavioral sciences at UT Health San Antonio and director of the STRONG STAR Consortium.

The consortium, led by UT Health San Antonio, is a national research network focused on finding the best preventions and treatments for psychological health issues affecting military members, veterans and first responders.

The contract, as previously announced, will see PharmAla develop a new 20mg clinical drug product dose of its LaNeo™ MDMA; This will allow significantly more variability in dosing for clinical trial practitioners, and eventually, for clinicians treating patients with MDMA-Assisted Therapy (MDMA-AT) in those countries where it is currently practicable. This study will be one of the first to examine the effects of MDMA-AT in a novel patient population, active-duty military personnel.

“We are incredibly excited to provide STRONG STAR at the UT Health San Antonio and Emory University (the two sites in this trial) with both our 40mg and newly-developed 20mg LaNeo MDMA™ Capsules,” said Nicholas Kadysh, CEO, PharmAla Biotech. “PharmAla is absolutely thrilled to be providing clinical drug product to the successful applicants in the recent $10M Department of Defense grant process. Having worked hard to support them during the grant application process, we will work even harder to ensure that the trials have the drug product they need to achieve successful results.”

About STRONG STAR

The South Texas Research Organizational Network Guiding Studies on Trauma and Resilience, or STRONG STAR, is a multidisciplinary and multi-institutional research consortium funded by the U.S. Departments of Defense (DoD) and Veterans Affairs (VA) and other agencies to develop and evaluate the most effective early interventions possible for the prevention, detection, diagnosis, and treatment of psychological health conditions in military personnel, veterans, and first responders.

Under the leadership of The University of Texas Health Science Center at San Antonio, STRONG STAR brings together the expertise of a world-class team of military, civilian, and VA institutions and investigators from across the country, unifying the critical mass of talent required to make significant research advances and to develop and deliver treatment programs that are relevant, effective, and feasible in military and VA settings.

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 significance of PharmAla's (MDXXF) new 20mg LaNeo MDMA dosage for clinical trials?

The new 20mg dosage provides greater flexibility for clinical trial practitioners and future clinicians in MDMA-Assisted Therapy, complementing the existing 40mg option.

How much funding did MDXXF receive for the STRONG STAR MDMA trial?

The project is part of a $10M Department of Defense grant through the Defense Appropriations Act.

Which institutions are involved in PharmAla's (MDXXF) MDMA-AT military PTSD study?

The study will be conducted at UT Health San Antonio and Emory University as part of the STRONG STAR Consortium.

What makes the MDXXF STRONG STAR trial unique in MDMA research?

It's one of the first studies to examine MDMA-Assisted Therapy effects specifically on active-duty military personnel with PTSD.