KLY Kalytera Therapeutics Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that the journal Scientific Reports, has published a peer-reviewed article reporting that R-107, the Company’s nitric oxide-releasing compound, effectively preserved multi-organ function in a sheep model of sepsis. These significantly positive data suggest that R-107 may be a potentially revolutionary new treatment for sepsis, a life-threatening condition, and the most frequent cause of death in intensive care units due to multiple organ failure.

Highlights

• R-107 was evaluated in a controlled large animal (sheep) model of sepsis, with significantly positive results. These results unequivocally demonstrated that R-107 reduced mortality, and provide important support for the Company’s development of R-107 for COVID-19 related sepsis.
• Sepsis is a potentially life-threatening condition that occurs when the body's response to an infection damages its own tissues and organs, and is the leading cause of death in COVID-19 patients, with a mortality rate of 30% - 40%.1
• The worldwide market for treatment of sepsis was valued at more than USD $600 million in 2020, and is projected to grow to USD $1.6 Billion by 2031.2
• Following completion of the Phase 1 clinical study of R-107 in Q1 2022, Claritas will apply for U.S. governmental grant funding from the Biomedical Advanced Research Development Authority (“BARDA”), an agency within the U.S. Department of Health and Human Services, to fund the Phase 2 and Phase 3 clinical studies of R-107 in COVID-related sepsis.

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

Doctor Perenlei Enkhbaatar is a member of the Company’s board of directors. Under his leadership 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

Although most COVID-19 infections cause mild to moderate illness with respiratory and flu-like symptoms, a significant number of patients progress 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 COVID-19 virus, 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 Will Develop R-107 for the Treatment of COVID-19 Related Sepsis Based on the Significantly Positive Data in Seen in the Ovine (Sheep) Model of Sepsis

“The data reported in the Scientific Reports article demonstrate that R-107 significantly reduced mortality in a 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.”

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 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

1 Health Leaders Media, Expert: Severe COVID-19 Illness is Viral Sepsis, Christopher Cheney, November 25, 20202 Sepsis Treatment Market To Reach Valuation Of US$ 1.6 Bn By 2031: Transparency Market Research, April 8, 20213 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