KLY Kalytera Therapeutics Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") is pleased to provide additional detail regarding exceptionally positive data with R-107 in a validated animal model of pulmonary arterial hypertension (“PAH”). These data are unprecedented in the scientific literature, and suggest that R-107 is a potentially revolutionary new treatment for PAH.

Highlights

• PAH is a lethal condition, with no cure, resulting from high blood pressure in the lungs.
• The worldwide market for treatment of PAH exceeds $6 billion per year and is projected to grow to $9.8 billion by 20271.
• R-107 is the first and only drug to demonstrate a durable reversal of established disease in a validated animal model of PAH.
• Claritas will initiate the Phase 1 clinical study of R-107 with CMAX in Adelaide, Australia, and expects to complete the study by Q4 this year.
• CMAX is one of Australia’s largest and most experienced clinical trial centers.

Exceptionally Positive Data from the Company’s Evaluation of R-107 in a Validated Animal Model of PAH

As previously disclosed, R-107 was evaluated in a validated animal model of PAH. The data from this study are unprecedented in the scientific literature, and suggest that R-107 is a potentially revolutionary new treatment for PAH.

Following are additional details regarding these data:

• Prevention of Disease Progression: The data demonstrate that R-107 therapy halts the otherwise unstoppable progression of PAH. The level of protection was total, i.e., administration of R-107 stopped all further vascular damage and hypertensive disease. This is a critical benefit because PAH is a lethal disease, inexorably worsening until death from heart failure. Although existing drugs for treatment of PAH may reduce the severity of symptoms and provide a modestly improved quality of life, they do not meaningfully slow the progression of the disease, i.e., they are not fundamentally disease modifying. R-107 is thus poised to be the first therapeutic agent to transform PAH from a lethal condition to a chronic treatable disease that can be stabilized and lived with long-term.
• Immediate and Near-Total Relief of Acute Symptoms: The data demonstrate that R-107 provides immediate and near total relief of the life-threatening symptoms of acute PAH. Rats treated with R-107 reproducibly responded within minutes of R-107 administration, as revealed by a prompt and near total fall in pulmonary blood pressure. In contrast, in the same animal model system, existing marketed drugs for treatment of PAH, such as sildenafil and bosentan, provide at best only half of this potency. Further, R-107 offered relief for a full 24 hours after a single dose, whereas sildenafil and bosentan were effective for a much shorter interval. Thus, R-107 is poised to be the most potent and long-lasting agent for relief of the life-threatening symptoms of acute PAH.
• Reversal (Potential Cure) of Disease: R-107 appears to be the first drug that can actually reverse PAH, i.e., it remodels the lung so that it returns to normal function, and normal function is maintained even after treatment with R-107 is completed. Whereas existing drugs for treatment of PAH can lower pulmonary blood pressure transiently, they cannot turn back the clock on patients with established severe disease. In the gold-standard rat model of the disease in which R-107 was tested, the introduction of a 2-week pulse of R-107 therapy in animals with well-established PAH resulted in a 75% reduction in blood pressure elevation that persisted, even days after R-107 therapy was concluded. Such results are, to the best of our knowledge, unprecedented in the scientific literature. Successful translation of these results in rodents to a clinical population would herald that patients with severe PAH could obtain a cure of existing well-established lethal disease.
• Superior Safety Profile: R-107 appears to be safer than existing drugs for treatment of PAH. Phosphodiesterase 5 inhibitors, such as sildenafil, and endothelin receptor antagonists, such as bosentan, have myriad unwelcome side effects, including liver injury, flushing, dizziness, nasal congestion, and penile erection. In contrast, formal FDA-mandated toxicology and safety pharmacology studies of R-107 have demonstrated to date that the drug is extremely well tolerated.

“We will initiate the Phase 1 clinical study of R-107 at CMAX in Adelaide, Australia by next month, and expect to complete the study by Q4 this year. CMAX is one of Australia’s largest and most experienced clinical trial centers. We will then initiate a Phase 2a clinical study of R-107 in hospitalized patients with COVID-19 related PAH early next year, which we expect to complete during Q3 next year,” said Robert Farrell, Claritas’ President and CEO.

Mr. Farrell continued, “Patients with severe COVID-19 exhibit a high prevalence of pulmonary vascular disease and the formation of numerous clots that obstruct blood flow as it courses through the lung. As the blood vessels in the lung are progressively blocked by clots and become engorged with blood, COVID-19 infection may produce severe PAH, causing acute stress and ballooning of the right side of the heart. In severe COVID-19 infection, this stress on the right side of the heart may become unsupportable and cardiac failure and death ensue. Professor Enkhbaatar, a member of Claritas’ Board of Directors, has addressed this disease pattern in a sheep model of severe lung infection and has demonstrated that R-107 prevents this type of damage to the lining of blood vessels and protects the right side of the heart from PAH and cardiac failure. Professor Cuzzocrea, also a member at Claritas’ Board of Directors, has addressed this phenomenon in a classic model of PAH and right-side heart failure in rats, and has shown that R-107 profoundly and immediately reduces PAH. To combat this same scenario in patients, our drug development plans call for a Phase 2a clinical study early next year in patients with the symptoms of PAH in COVID-19 pneumonia. Based on the exceptionally positive results that we have observed in both rat and sheep models of lung infection and PAH, we expect to see a quick and dramatic reduction in the symptoms of PAH in these patients with COVID-19 pneumonia.”

R-107 is a Nitric Oxide-Releasing Compound

R-107 is a liquid nitric oxide-releasing compound with issued and pending composition of matter and method of use patents in approximately 40 countries, including the U.S., Australia, Brazil, China, Europe, India, Japan, Russia and South Korea.

Claritas Will Develop R-107 as a Nitric Oxide Therapy for Treatment of Viral Infections, Including COVID-19, and Pulmonary Arterial Hypertension

R-107 is a platform technology that transforms nitric oxide therapy from an impractical, expensive, and difficult to administer inhalation therapy, into a practical treatment that can simply be administered by capsule, injection, or nasal spray. It has been demonstrated that nitric oxide is a potent antiviral therapy, and for this reason, Claritas will develop R-107 as a nitric oxide broad-spectrum antiviral treatment for therapy and prevention of coronavirus, vaccine-resistant COVID-19 infection, influenza, and the common cold. For the reasons discussed above, Claritas will also develop R-107 as a nitric oxide therapy for PAH, including life-threatening COVID-19 associated PAH. With the recent resurgence of COVID-19 infection, and the report from Israel that the Pfizer vaccine loses 60% efficacy within six months, the importance of a safe and effective drug therapy for Coronavirus cannot be underestimated.

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 Pulmonary Arterial Hypertension Market Size Worth $9.8 Billion By 2027, Grand View Research, February 2020