CLAS Claritas Pharmaceuticals Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that a recently published study led by clinicians at Royal Brompton & Harefield NHS Foundation Trust1 validates the potential of the Company’s proprietary nitric oxide releasing compound, R-107, as a potential therapy for coronavirus and COVID-19 infection. In the cited study, inhaled nitric oxide was seen to significantly improve oxygen levels administered in patients with severe COVID-19 pneumonia.

The study at Royal Brompton & Harefield NHS Foundation Trust was the largest of its kind worldwide. In this study, 35 Patients with COVID-19 pneumonia who were on ventilation were given inhaled nitric oxide as part of routine care when they were failing to respond to best standard treatments. This led to significant improvements in oxygen levels and improvements in ventilatory efficiency at 24 hours and for up to five days.

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 CompoundR-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.

____________1 Garfield B., McFadyen C., Briar C., Bleakley C., Viachou A., Baldwin M., et. al., British Journal of Anaesthesia, Volume 126, Issue 2, E72-E75, February 01, 2021.

Nitric Oxide is a Critical Part of the Body’s Natural Defense System Against VirusesNitric 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 ContactNitric 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.

________________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 Israel, people vaccinated before late February this year are twice as likely to contract COVID-19 infection as are people inoculated after that date. “We looked at tens of thousands of people tested in the month of June, alongside data on how long had passed since their second shot, and found that those vaccinated early were more likely to test positive,” stated Dr. Yotam Shenhar, who headed the research. The report, published by the Israeli healthcare provider Leumit, follows other Israeli studies that suggest decreasing vaccine effectiveness, partly as a result of the Delta variant and partly because of the passage of time.

“Given the potential waning of the effectiveness of the COVID-19 vaccines, and the positive outcomes observed in the study at Royal Brompton & Harefield NHS Foundation Trust, we are convinced of the importance of our program to develop R-107 as a treatment for coronavirus and vaccine-resistant COVID-19 infection,” stated Robert Farrell, Claritas’ President and CEO.

“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 Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society is working with 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 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. ("Claritas") is committed to developing new treatments for a variety of diseases and disorders, by discovering, developing, manufacturing and delivering innovative human therapeutics. 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.

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Cautionary StatementsNeither 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 InformationRobert FarrellPresident, CEO(888) 861-2008info@claritaspharma.com