PharmaTher Advancing Research for Novel Microneedle Delivery of Ketamine

Represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders

TORONTO, March 24, 2021 /CNW/ - Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), today announced that its wholly-owned subsidiary, PharmaTher Inc. ("PharmaTher"), a psychedelics biotech company, has entered into a sponsored research agreement with The Queen's University of Belfast ("QUB") for the development of a patented hydrogel-forming microneedle ("MN") patch to deliver ketamine and the PharmaTher's proprietary ketamine formulation, KETABET™". This advance represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.

The research will be led by Professor Ryan Donnelly, a world leader in the research of microneedle delivery technologies. Most recently, Professor Donnelly's lab successfully completed research and published a paper titled Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery. His research validates the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1

The proposed ketamine and KETABET™ MN patch offer a potential game-changing therapeutic solution for various unmet medical needs. Ketamine is becoming an emerging treatment option for major depressive disorder2, bipolar depression3, depression with suicidal ideation4 and post-traumatic stress disorder5. Despite its potential, ketamine has the potential for abuse and misuse—leading to problems such as dissociative, hallucinogenic and amnesic effects6. These risks have led to its limited clinical use and discontinuation.

KETABET™ has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.7

PharmaTher's patented MN technology consists of hydrogel-forming microneedle arrays and accompanying reservoir (Figure #1) which will overcome any limitations by the quantity of drug that can be loaded into the needles or onto the needle surfaces. As such, the MN technology can greatly increase the amount of drug that can permeate through the microneedle array and into the skin8.

As a result, PharmaTher's KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office. KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.1,8

Also, PharmaTher's KETABET™ MN patch will incorporate anti-tampering and anti-abuse features. The combined presence of ketamine and betaine and the delivery format of the product would parallel the approach used by tamper-resistant transdermal fentanyl patches.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray and in March 2019 approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc. SPRAVATO® requires numerous administration sessions in a certified medical office under medical supervision by a health care provider.9 An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.10

"The potential for ketamine is significant and we are leading the way to develop a better ketamine solution to treat these unmet medical needs," said Fabio Chianelli, CEO of PharmaTher. "We believe that ketamine and our proprietary ketamine formulation, KETABET™, delivered in the patented microneedle patch could potentially change the ways that mental health, neurodegenerative and pain disorders are treated. We are pursuing the clinical development of KETABET™ MN patch to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine as a prescription for regulatory approval worldwide. We look forward to working with Professor Donnelly in delivering the next generation ketamine solution."

Professor Ryan Donnelly commented, "Our lab has successfully delivered esketamine using our patented microneedle technology, which shows the potential of an alternative delivery method that can overcome the limitations of current ketamine delivery options without comprising the safety and compliance of patients. We are excited to work with PharmaTher in their quest to develop a next generation ketamine solution that could help the millions of people who suffer from mental health worldwide."

PharmaTher will focus on developing a microneedle patch for FDA approval to better deliver psychedelics that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat neuropsychiatric, neurodegenerative and pain disorders.

Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

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References:
1. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
2. Murrough et al. 2013; Wan et al. 2014
3. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
4. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
5. Feder et al. 2020
6. Krystal et al. 1994; Perry et al. 2007
7. 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.
8. Donnelly R.F. Hydrogel-forming microneedles prepared from "super swelling" polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
9.https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
10.https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda