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Claritas Pharmaceuticals (formerly Kalytera Therapeutics) to Focus on Development of R-107 as a Therapy for Vaccine-Resistant COVID-19, Influenza, and Other Viral Infections

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SAN FRANCISCO and TORONTO, March 01, 2021 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (formerly Kalytera Therapeutics, Inc.), (TSX VENTURE EXCHANGE: KLY and OTC: KALTF) (the "Company" or "Claritas") today announced that the Company will focus its resources primarily on development of its nitric oxide-releasing compound, R-107, for the treatment of vaccine-resistant COVID-19, and other viral infections.

The Science of R-107 and Nitric Oxide

R-107 Is a Nitric Oxide-Releasing Compound
R-107 is a nitric oxide-releasing compound. Following administration orally in a capsule, or by nasal spray, or by injection, R-107 enters the bloodstream, where it slowly releases nitric oxide systemically over 24 hours.

Nitric Oxide is a Critical Part of the Body’s Natural Defense System Against Viruses
Nitric oxide is a natural molecule with antiviral properties that is produced by the body itself. It is an integral part of the body’s natural defense system. When a viral threat is present, white blood cells migrate to the area of infection and release a burst of nitric oxide that crosses into the infected cell and inactivates the virus, so that it is incapable of further replication and spread.

Nitric Oxide - Kills Viruses on Contact
Nitric oxide is known to have a broad antiviral activity against multiple viruses, including those whose genes are encoded by RNA, so-called “RNA viruses”.1 The SARS-CoV-2 virus, which is responsible for COVID-19 infection, is an RNA virus. Other RNA viruses of importance that cause human disease include influenza, SARS, the common cold, hepatitis C, hepatitis E, West Nile fever, rabies, and measles.

  • Vancouver-based SaNOtize Research and Development Corporation has recently announced anti-viral data from laboratory studies that were conducted by the Institute for Antiviral Research at Utah State University. The results of these studies confirm that nitric oxide administered through use of their proprietary delivery technology inactivated more than 99.9% of SARS-CoV-2 virus within two minutes.2

R-107 - A Potential Breakthrough in Nitric Oxide Therapy
The historical challenge with nitric oxide therapy has been the difficulty of delivering the molecule in an effective and practical manner. Nitric oxide that exists as a gas must be delivered by inhalation therapy requiring use of a CPAP-like device and administration by trained respiratory therapists. For these reasons, use of nitric oxide gas use is expensive, complex, and cumbersome, and therefore its application has been quite limited.

R-107, on the other hand, is a breakthrough compound designed to overcome the limitations of nitric oxide inhalation therapy.

  • R-107 – A Potentially Superior Route of Administration Transforms Nitric Oxide into a Practical Therapy
    Unlike nitric oxide gas, which must be administered as an inhalation therapy, R-107 is a liquid that may be readily administered orally in a capsule, or nasally though use of a nasal spray, or by a single intramuscular or subcutaneous injection. Due to its ease of administration, R-107 is expected to allow treatment without the need for special delivery equipment or trained respiratory therapists. In this manner, R-107 may overcome the challenges inherent in the administration of nitric oxide gas, and transform nitric oxide therapy into a potentially best-of-care treatment for COVID-19 infection, and potentially other viral infections as well.

  • R-107 – Designed to Act Throughout the Body – Not Only in the Lungs
    When inhaled, nitric oxide gas is absorbed into the lung tissues, where it has a half-life of only a few seconds. Accordingly, it is believed that inhaled nitric oxide may eliminate virus in the lungs, but does not survive long enough within the circulation to reach distant organs and eliminate their viral infection. In contrast, following administration of R-107 by either the oral, or nasal or injectable route, R-107 enters the bloodstream, where it is stable and can slowly release nitric oxide systemically over 24 hours. R-107’s systemic release of nitric oxide would thus potentially allow elimination of virus in all organs and tissues, not only in the lungs.

    In addition to its apparent advantages in systemic administration and simplicity of administration, R-107 does not lose its potency after prolonged periods of clinical use. In contrast, other nitric oxide donors in liquid form, such as nitroglycerin and amyl nitrate, rapidly induce tolerance and lose their biological activity after more than a single dose. Accordingly, R-107 is poised to become a more effective, less expensive, and more easily administered form of nitric oxide that could potentially transform this agent into a frontline therapy against COVID-19 and other viral infections.

“R-107 will play an important role in the fight against COVID-19, and vaccine-resistant variants of the COVID-19 virus. We intend to become a leader in the race to find a treatment for COVID-19, and we are well positioned to achieve this goal,” stated Robert Farrell, President and CEO of Claritas. “However, our goal is more ambitious than that: we intend to develop R-107 as a broad-spectrum antiviral drug for the treatment of, and possible prevention of, future viral outbreaks. We are working closely with the Salzman Group to develop R-107 to treat, and possibly prevent, COVID-19 infection, as well as influenza and common colds caused by adenovirus, coronavirus and influenza virus.”

Mr. Farrell continued, “Nitric oxide has generally demonstrated the ability to inhibit viral replication of RNA viruses, and there is an extensive body of in vitro and in vivo data demonstrating the ability of nitric oxide to prevent the replication and transmissions of several of these viruses. Based on these data, we intend to develop our proprietary R-107 technology as a therapy for COVID-19 infection, as well as a therapy for other RNA viruses, including the influenza virus.”

Professor Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society, is working with Salzman Group and Claritas, and has read and approved of the scientific disclosure in this news release. Professor Cuzzocrea has deep expertise regarding the medical use of nitric oxide and nitric oxide donors, and has published more than 600 papers on inflammation and nitric oxide. He has conducted research and experiments with nitric oxide and nitric oxide donors since 1994, and worked closely as an advisor with the Salzman Group team that designed and invented R-107.

The Company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.

About Claritas Pharmaceuticals
Claritas Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs. Claritas focuses on areas of unmet medical need, and leverages its expertise to find solutions that will improve health outcomes and dramatically improve people's lives.

Cautionary Statements
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release may contain certain forward-looking information and statements ("forward-looking information") within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives, and other statements containing the words "believes", "anticipates", "plans", "intends", "will", "should", "expects", "continue", "estimate", "forecasts" and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavorable results. Claritas undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Claritas believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Claritas’ control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Claritas disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Contact Information
Robert Farrell
President, CEO
(888) 861-2008

1 Nathan C., Xie Q.W. Nitric oxide synthases: roles, tolls, and controls. Cell. 1994;78:915–918. doi: 10.1016/0092-8674(94)90266-6. [PubMed] [CrossRef] [Google Scholar]

2 SaNOtize Research and Development Corp., Press Release dated April 22, 2020: New Laboratory Tests Conducted by Utah-Based Institute for Antiviral Research Confirm SaNOtize’s Nitric Oxide Releasing Solution (NORSTM) is Over 99.9% Effective Against SARS-CoV-2, the Virus that Causes COVID-19

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