TORONTO, Sept. 29, 2021 — 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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- 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.