CLAS Claritas Pharmaceuticals Inc

Claritas Pharmaceuticals, Inc. (TSX VENTURE EXCHANGE: CLAS and OTC: CLAZF) (the "Company" or "Claritas") today announced that the Australian Human Research Ethics Committee has approved the Company’s submission for the Phase 1 clinical study of R-107 to be conducted at Scientia Clinical Research in Sydney, Australia. Claritas will now immediately begin enrollment in the study.

Highlights

• Claritas has received approval of its Phase 1 clinical study of R-107 from the Australian Human Research Ethics Committee (the “HREC”).
• HREC approval is the final regulatory step prior to initiation of the clinical study.
• Enrollment of subjects in the clinical study will begin immediately.

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.

Nitric Oxide Therapy

Nitric oxide is a natural molecule produced by nearly every cell type in the body. In 1998, nitric oxide was the subject of the Nobel Prize in medicine, and since that time, more than 130,000 peer reviewed articles have been published on nitric oxide and its many biological functions. Inhaled nitric oxide is approved for treatment of persistent pulmonary hypertension of the newborn (“PPHN”). It has also been proposed as a long-term therapy for pulmonary arterial hypertension (“PAH”) in adult patients.

R-107 will Transform the Field of Nitric Oxide TherapyNitric oxide exists as a gas and must be delivered by inhalation therapy requiring use of a CPAP-like device and administration by trained respiratory therapists. For these reasons, use of nitric oxide gas is expensive and cumbersome, and therefore its application has been limited.

R-107 is a breakthrough compound designed to overcome the limitations of nitric oxide inhalation therapy. Unlike gaseous nitric oxide, R-107 is a liquid that can be administered by mouth (in a capsule), by nasal spray, by nebulizer, by injection, by suppository (vaginally or rectally) or topically (in an ointment).

R-107, holds the key to unlocking the full potential of nitric oxide, and we believe it is the only drug in development capable of doing this.

Phase 1 Study OverviewThe Phase 1 study will be a double-blind, single-center, single ascending dose escalation study that will evaluate the tolerability, safety, and pharmacokinetics of R-107 intramuscular injection. The study will enroll a total of 40 subjects, with 8 subjects in each of 5 cohorts.

Potential of R-107 in the Treatment of PAH

Following completion of the Phase 1 study, Claritas will initiate a Phase 2a clinical study of R-107 in the treatment of in pulmonary arterial hypertension (“PAH”), which is a USD $6 billion commercial opportunity with the currently approved drugs, and which is projected to grow to USD $9.8 billion by 2027.1  

“The data that we have with R-107 in the treatment of PAH is of particular importance and is indictive of the potential value of R-107,” stated Robert Farrell, Claritas’ President and CEO.

Mr. Farrell went on to say, “R-107 was evaluated in the same animal model of PAH in which the currently approved drugs for PAH were also tested. The results of this study were exceptional. R-107 was observed to be superior to all currently approved drugs in reducing pulmonary arterial blood pressure. R-107 was also seen to reverse the severity of the disease after a short course of therapy. R-107 is the first and only drug to demonstrate the ability to reverse established disease. Based on these exceptionally positive and unique findings, 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 2 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.”

Claritas has already begun outreach to pharmaceutical companies in the PAH space and is in discussions with two such companies.

Other Potential Markets for R-107Depending on how it is administered, R-107 can target multiple diseases, disorders, and injuries. For example, R-107 can be administered through use of a nebulizer or bi injection to target lung diseases, such as PPHN and COVID-related sepsis and ARDS, or it can be administered in an ointment to target wound healing.

In addition to the Phase 2a clinical study in PAH, Claritas will also initiate a Phase 2 study in PPHN. Inhalable nitric oxide (“iNO”) is already approved for the treatment of PPHN, however, we believe that R-107 will have significant advantages over iNO in the treatment of PPHN. The global iNO market was valued at USD $634.4 million in 2019 and is estimated to reach approximately USD $1.181 billion by 2027, with most of these revenues allocable to the treatment of PPHN.2

Potential Collaboration with BARDA

More than $15M of the $20M cost for the preclinical development of R-107 was funded by the U.S. Department of Health and Human Services under a contract with the Biomedical Advanced Research and Development Authority (“BARDA”). Following completion of the Phase 1 study, Claritas will again seek such funding for the costs of Phase 2 studies of R-107 in the treatment of

sepsis and ARDS. 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 20313, and according to an analysis by Reports and Data, the global ARDS market was valued at USD 583.8 million in 2018 and is expected to reach USD 934.8 million by the year 2026.

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.

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

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 because 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 20202 Allied Market Research, Inhaled Nitric Oxide Market, 2021

3 Sepsis Treatment Market to Reach Valuation of US$ 1.6 Bn By 2031: Transparency Market Research, April 8, 2021