The study at
COVID-19
COVID-19 is caused by a coronavirus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The Science of Nitric Oxide and R-107
Claritas is developing R-107 for the potential treatment of vaccine resistant COVID-19 infection and pulmonary arterial hypertension (“PAH”).
R-107 Is a Nitric Oxide-Releasing Compound
R-107 is a proprietary nitric oxide-releasing compound. Following administration, R-107 enters the bloodstream, where it slowly releases nitric oxide systemically over 24 hours.
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1 Garfield B., McFadyen C., Briar C., Bleakley C., Viachou A., Baldwin M., et. al.,
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”.2 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.
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 exists as a gas must be delivered by inhalation therapy requiring use of a CPAP-like device and administration by trained respiratory therapists. 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.
R-107, on the other hand, is a breakthrough compound designed to overcome the limitations of nitric oxide inhalation therapy. R-107 is a liquid that may be readily administered orally in a capsule, or by an intramuscular or subcutaneous injection. Following administration, 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.
COVID-19 Pneumonia
Most patients who contract COVID-19 have mild or moderate symptoms like coughing, a fever, and shortness of breath. However, about 15% of patients develop severe infection and often present with pneumonia in both lungs.
COVID-19 Pneumonia and PAH
Pulmonary arterial hypertension (“PAH”) is a frequent complication of COVID-19 pneumonia. The spike protein of the COVID-19 virus damages the endothelium, the lining of the blood vessels. In the blood vessels of the lungs, this damage results in clots that increase pulmonary blood pressure. As the blood vessels in the lung are progressively blocked by clots and become engorged with blood, arterial blood pressure or PAH increases, leading to acute stress and ballooning of the right side of the heart. This stress on the right side of the heart may become unsupportable and cardiac failure and death ensue.
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2 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.
R-107 in Treatment of Severe COVID-19 Pneumonia and PAH
In the gold-standard animal model of PAH, R-107 was seen to prevent damage to the lining of blood vessels in the lungs and to protect the right side of the heart from PAH and cardiac failure. In this study, R-107 profoundly and immediately reduced PAH.
Risks of Decreasing Vaccine Effectiveness and COVID-19 Infection
According to a report recently published in
“Given the potential waning of the effectiveness of the COVID-19 vaccines, and the positive outcomes observed in the study at
“A COVID-19 treatment will be essential to manage illness resulting from vaccine-resistant strains of the virus, as well as potentially providing a rescue therapy for patients who did not receive a vaccine or for whom the vaccine is no longer effective.”
Professor
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.
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Cautionary Statements
Neither
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.
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