KLY Kalytera Therapeutics Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that it has entered into a License Amendment dated December 17, 2021 (the “License Amendment”) under which Salzman Group, Inc. (a Delaware corporation), Salzman Group, Ltd. (an Israeli corporation), and Salzman Group Pty. Ltd. (an Australian corporation), (collectively, the “Salzman Group”), have granted to Claritas an exclusive, worldwide license to develop and commercialize R-107 for the treatment of pulmonary diseases, including pulmonary arterial hypertension (“PAH”) acute respiratory distress syndrome (“ARDS”), and persistent pulmonary hypertension of the newborn (“PPHN”). The Company has received all regulatory approvals for the License Amendment, including approval of the TSX Venture Exchange.

Highlights

• Claritas is currently developing R-107, its proprietary nitric oxide-releasing compound, for the treatment of viral infections, including COVID-related ARDS, and COVID-related sepsis.
• Under the License Amendment, Claritas will now have world-wide rights to develop R-107 for the treatment of pulmonary diseases, including PAH and PPHN. The Company will shortly issue a separate press release providing details regarding the medical and business rationales for developing R-107 as a treatment for PPHN.
• The Company expects to initiate a Phase 2a study of R-107 in PAH by Q3 2022; and a Phase 2a study of R-107 in PPHN by year-end 2022.
• PAH and PPHN are lethal conditions, 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 2027.1
• R-107 is the first and only drug to demonstrate a durable reversal of established disease in a validated animal model of PAH.
• Claritas’ development strategy for R-107 in PAH is designed to expedite the potential monetization of this asset.

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.

The License Amendment

Claritas initially licensed R-107 from the Salzman Group for the treatment of COVID-19 and other viral infections under a License Agreement dated July 16, 2020 (the “License Agreement”). Claritas and the Salzman Group have now entered into the License Amendment to include the grant from the Salzman Group to Claritas of an exclusive, worldwide license to develop and commercialize R-107 for the treatment of pulmonary diseases, including PAH and PPHN.

Claritas Will Develop R-107 as a Nitric Oxide Therapy for Treatment of PAH

“R-107 is a technology that transforms nitric oxide therapy from an impractical, expensive, and difficult to administer inhalation therapy, into a practical treatment that can be administered by capsule or by injection,” stated Robert Farrell, Claritas’ President and CEO. “It has been demonstrated that nitric oxide is clinically effective in the treatment of PAH.2 For this reason, we have now acquired exclusive, worldwide rights to develop R-107 as a nitric oxide therapy for PAH.”

Exceptionally Positive Data from the 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.

Mr. Farrell went on to say, “Based on the exceptionally positive data we saw in the validated animal model of PAH, we believe that R-107 could become a best-in-class, front-line therapy for PAH. If we can demonstrate similar data with R-107 in a Phase 2a clinical study in humans, we believe that R-107 will be viewed as a potentially valuable pharmaceutical asset that we might seek to out-license or sell. We will complete our Phase 1 clinical study by Q1 next year, and we expect to complete the Phase 2a study of R-107 in the treatment of PAH in 2022.”

Mr. Farrell concluded, “With the addition of R-107 for treatment of PAH, Claritas now has two programs addressing large commercial markets. In addition to our program developing R-107 for treatment of viral infections, including COVID-related lung disease, we now also have a potential breakthrough product that could provide unrivalled results in treatment of PAH.”

Pulmonary Arterial Hypertension (“PAH”)

PAH is a critical unmet medical need. PAH is characterized by high blood pressure in the arteries of the lungs. It is a serious condition that makes it difficult for blood to flow through the lungs, which, in turn, forces the heart to work harder than normal. It is a chronic and progressive disease. Over time, PAH will worsen, and may limit physical activities. Patients have a poor prognosis and low survival rate. There is currently no cure for PAH, although there are several approved drugs that can ease the symptoms of the disease. However, all of the currently approved drugs have significant side effects that limit their acceptability. The current market for such drugs exceeds $6 billion per year, and the market is projected to grow to $9.8 billion per year by 2027.3

Claritas’ Development Plan for R-107 in PAH is Designed to Expedite the Monetization of this Asset by Year-End 2022.

Claritas expects to complete the Phase 1 clinical study of R-107 in Q1 2022, and complete of a small Phase 2a clinical study of R-107 in hospitalized patients in 2022.

The Phase 2a clinical study will be conducted in Australia in hospitalized patients in the catheterization laboratory to establish proof of concept that R-107 is effective in reducing blood pressure in the lungs. Patients will be on study for 24-hours. Due to the short duration of the study and the relatively small number of patients that will be enrolled in the study, the Company believes that the study can be conducted at a single site, and completed within no more than one-month.

Demonstration of proof of concept could provide the scientific foundation for immediate sale or strategic licensing of the asset on highly favorable terms. If Claritas is able to demonstrate a drop or reversal of blood pressure similar to what was demonstrated in the validated animal model of the disease, the Company believes that R-107 will be viewed as a significantly valuable pharmaceutical asset, and achievement of the Phase 2a endpoints should constitute a major inflection point in value.

Terms of the License Amendment

Under the terms of the License Amendment, Claritas has agreed to provide the following compensation to Salzman Group:

• Claritas will issue 1.2 million shares of Claritas common stock to Salzman Group Pty. Ltd. Provided, however, that Claritas will not issue any common shares to Salzman Group Pty. Ltd. unless Salzman Group Pty. Ltd. and all affiliates certify that the issuance of such common shares will not cause Salzman Group Pty. Ltd. and its affiliates to beneficially own in excess of 19.99% of the Company’s outstanding shares of common stock;
• Claritas has paid cash license fees of USD $12,300 to Salzman Group Pty. Ltd. and USD $287,700 to Salzman Group Ltd.; and
• Claritas will also pay the following cash milestone payments and royalties on net sales to Salzman Group:
  • USD $2.0 million on successful completion of a pivotal Phase 3 registration study in the PAH indication
  • USD $2.0 million on submission of an NDA to the U.S. FDA for R-107 treatment of the PAH indication
  • USD $5 million on FDA approval for the PAH indication
  • USD $5 million on EMEA approval for the PAH indication
  • USD $5 million on Japanese approval for the PAH indication
  • During the applicable term of any patent covering R-107 in the treatment of PAH, Claritas will pay to Salzman Group, Inc. a royalty of eight percent (8%) of the net sales for all R-107 products for the treatment of PAH

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.

• Website Home: https://claritaspharma.com/
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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

2 Nitric Oxide and Pulmonary Arterial Hypertension, Glob Cardiol Sci Pract. 2017 Jun 30; 2017(2): 14.: Adrian H. Chester, Magdi H. Yacoub, and Salvador Moncada

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