PharmaTher Retains Former FDA Psychiatry Division Director Dr. Thomas Laughren as Regulatory Affairs Advisor

Rhea-AI Summary

PharmaTher Holdings Ltd. (OTCQB: PHRRF) has appointed Dr. Thomas Laughren as a Regulatory Affairs Advisor to assist in regulatory matters concerning KETABET™, a novel formulation combining FDA-approved ketamine and betaine for treating neuropsychiatric disorders. Dr. Laughren, with 29 years of experience at the FDA, will help finalize the IND application for a Phase 2 study on KETABET™ targeting depression. The treatment aims to mitigate major depressive disorder symptoms in over 300 million people globally, potentially enhancing ketamine's efficacy while reducing its side effects.

Positive

• Appointment of Dr. Thomas Laughren as Regulatory Affairs Advisor enhances regulatory oversight and expertise.
• KETABET™ is positioned as a potential novel treatment for major depressive disorder, targeting over 300 million sufferers worldwide.
• KETABET™ may enhance antidepressant effects while minimizing ketamine's known adverse side effects, potentially increasing patient compliance.

Negative

• None.

TORONTO, Sept. 29, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that Dr. Thomas Laughren has been retained by PharmaTher as a Regulatory Affairs Advisor. Dr. Laughren will advise on regulatory matters as it pertains to KETABET™, the Company’s patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for neuropsychiatric disorders.

Dr. Thomas Laughren formerly served as the Director for the Division of Psychiatry Products, Center for Drug Evaluation and Research at the FDA where he served for 29 years. During his tenure as Director for the Division of Psychiatry Products, Dr. Laughren managed the review of all psychiatric drug development activities conducted under INDs and the review of all New Drug Applications and supplements for new psychiatric drug claims.

Dr. Laughren will work with Dr. Maurizio Fava, MD, the Company’s Scientific and Clinical Advisor, and Psychiatrist-in-Chief at Massachusetts General Hospital, to complete the Investigational New Drug (“IND”) application for submission to the FDA for evaluating KETABET™ in a Phase 2 clinical study as a potential treatment for depression.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are pleased to have Dr. Laughren as a regulatory advisor to support our clinical and commercial initiatives with KETABET™ in depression and other neuropsychiatric disorders.”

KETABET™ is being developed by the Company as a potential novel treatment option for neuropsychiatric disorders, including for the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide.   KETABET™ has shown in a research study to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.¹  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
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Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

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", "potential", "aim" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") 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 the Company 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. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company 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. The foregoing statements expressly qualify any forward-looking information contained herein. 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 Company's management's discussion and analysis for the period of May 31, 2021 ("MD&A"), dated September 7, 2021, which is available on the Company'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.

References:

1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32.
   

FAQ

What is the significance of Dr. Thomas Laughren joining PharmaTher as a Regulatory Affairs Advisor?

Dr. Laughren's extensive experience at the FDA will provide valuable insights into regulatory processes, aiding in the development of KETABET™.

How does KETABET™ aim to improve treatment for depression?

KETABET™ combines ketamine and betaine, potentially increasing antidepressant effects while reducing negative side effects associated with ketamine.

What are the next steps for PharmaTher regarding KETABET™?

PharmaTher is preparing to submit the Investigational New Drug (IND) application to the FDA for a Phase 2 clinical study of KETABET™.

What is the target market for KETABET™?

KETABET™ targets the treatment of major depressive disorder, which affects over 300 million people worldwide, including those resistant to current treatments.