CLAS Claritas Pharmaceuticals Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that, based on significantly positive results in a controlled large animal model of sepsis, the Company will now expand its R-107 development program to include the treatment of COVID-19 related sepsis, the leading cause of death in COVID-19 patients.  

Highlights 

• Claritas is currently developing R-107 for the treatment of viral infections, including vaccine-resistant COVID-19. 
• Claritas will also now expand this program to include development of R-107 for the treatment of COVID-19 related sepsis. 
• Sepsis is the leading cause of death in COVID-19 patients, with a mortality rate of 30% - 40%.1

Positive Results with R-107 in Treatment of Sepsis in Ovine Model of the Disease

Under the leadership of Professor Perenlei Enkhbaatar at the University of Texas Galveston Medical Branch, sepsis was induced in 22 adult female Merino sheep by intravenous administration of the gram-negative bacillus Pseudomonas aeruginosa. This infection model produces a highly reproducible and rapidly lethal form of septic shock that precisely mimics the clinical presentation in human patients of cytokine storm, acute lung injury, loss of vascular tone, severe oxidant stress and multiple organ failure. Although rodent models are useful in the study of novel therapies for sepsis, the demonstration of efficacy in a large animal model, such as in sheep, is more predictive of results in the human clinical setting, and is a necessary step in the advancement of any novel treatment for viral sepsis in man. A control group consisted of 13 sheep that were treated with an intramuscular injection of saline. The results of this study unequivocally demonstrated that R-107 treatment reduced mortality, with 11% mortality noted among those sheep treated with R-107 versus 30% mortality observed among those sheep in the control group. R-107 therapy significantly decreased lung injury, eliminated oxidant stress and preserved multi-organ function. There were no adverse effects observed in response to R-107 treatment. Taken together, the observations that R-107 is highly effective and safe in this large animal model provide critical support for the Company’s development of R-107 for COVID-19 related sepsis.

Sepsis is the Leading Cause of Death Among COVID-19 Patients

More than 100 million confirmed cases of COVID-19 infection and more than two million associated deaths have been counted around the globe by the end of January 2021.2

Most COVID-19 infections cause mild to moderate illness with respiratory and flu-like symptoms, including fever, chills, cough and sore throat. However, in a significant number of patients the disease progresses from these initial mild symptoms to more serious and potentially fatal viral sepsis. In COVID-19 viral sepsis, the body has a dysregulated immune response to the coronavirus, which causes severe oxidant stress and life-threatening dysfunction in organs including the lungs, brain, kidneys, heart, and liver. COVID-19 viral sepsis is the leading cause of death among COVID-19 infected patients, with a mortality rate in the range of 30% - 40%.3

Claritas is Expanding its COVID-19 Program to Include Treatment of COVID-19 Related Sepsis Based on Significantly Positive Data in Ovine Model of Sepsis

“The data we are announcing today demonstrate that R-107 significantly reduced mortality in an aggressive and clinically-predictive animal model of sepsis. The importance of these data cannot be overstated,” said Robert Farrell, Claritas’ President and CEO. “While bacterial sepsis may be treated with antibiotics, this is not the case with COVID-19 viral sepsis. Approved therapies, such as remdesivir, dexamethasone and bamlanivimab, are helpful for patients with mild illness, but are not particularly effective in COVID-19 patients who have developed sepsis. For COVID-19 patients who have developed sepsis, there are few available therapies beyond supportive care.”4

Mr. Farrell went on to state that, “Our data unequivocally demonstrate that R-107 treatment reduced mortality in a controlled study in a large animal model of sepsis. We are aware of no other drug that is marketed or in development that has achieved superior results in this animal model of the disease.”

R-107’s Mechanism of Action in Treatment of Sepsis

Sepsis directly damages the inner lining of the blood vessels (the “endothelium”) within the lung, so that circulating white cells are trapped, and can then transit into the tissue, causing inflammatory injury. Sepsis also diminishes the concentration of nitric oxide within the lung, resulting in an increase in the tone of pulmonary blood vessels and a rise in the blood pressure of arterial blood coursing through the lungs.

In the presence of R-107, or its active payload R-100, nitric oxide is released and is able to protect the endothelium, ensuring that white cells transit the microvasculature without attaching to the endothelium and entering the lung and other tissues. By maintaining the blood within the vascular compartment, and preventing its egress into lung tissue, R-107 ensures that the lung tissue remains free of edema, so that oxygen from the air may be readily exchanged with circulating blood.

When nitric oxide is released by R-107, or its active payload R-100, it releases the constriction of the pulmonary vasculature, thereby diminishing the blood pressure throughout the lung and permitting blood to travel more easily through the lung.

Professor Salvatore Cuzzocrea, President of the University of Messina and former President of the European Shock Society has read and approved 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 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 PharmaceuticalsClaritas 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.

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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

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1 Health Leaders Media, Expert: Severe COVID-19 Illness is Viral Sepsis, Christopher Cheney, November 25, 20202 Elezkurtaj, s., Greuel, S., Ihlow, J. et al. Causes of Death and Comorbidities in Hospitalized Patients with COVID-19. Sci Rep 11, 4263 (2021) 3 Health Leaders Media, Expert: Severe COVID-19 Illness is Viral Sepsis, Christopher Cheney, November 25, 20204 Health Leaders Media, Expert: Severe COVID-19 Illness is Viral Sepsis, Christopher Cheney, November 25, 2020