Claritas Announces Receipt of Comments from Australian Ethics Committee Regarding the Company’s Phase 1 Clinical Study of R-107 and Closing of Financing

SAN FRANCISCO, CA and TORONTO, ON , Feb. 22, 2022 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that it has received comments from the Australian Human Research Ethics Committee (the “HREC”) regarding the Company’s Phase 1 clinical study of R-107, and is providing an update regarding the company’s previously announced financing with Alumina Partners (Ontario) Ltd. (“Alumina”).

Claritas will respond to the HREC’s comments later this week and expects to receive approval for the Phase 1 study shortly thereafter. HREC approval is the final regulatory step prior to initiation of the study.

“The comments we received from the HREC will not require that we make any changes to the Phase 1 study design,” stated Robert Farrell, Claritas’ President and CEO. “In general, the HREC requested clarification regarding the mechanism of action of R-107, and its active payload, R-100. When administered by injection, R-107 is slowly hydrolyzed, releasing its active moiety, R-100, which in turn steadily and slowly releases nitric oxide. This depot-like action of R-107 results in a sustained delivery of nitric oxide, allowing for a smooth delivery of the active drug over several hours following a single dose of R-107. Put simply, following injection, R-107 is metabolized, and releases R-100, which in turn releases nitric oxide. R-100 is the payload of R-107. The HREC requested clarification regarding the mechanisms of action for both R-107 and R-100.”

Phase 1 Study Overview

The 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. The study is being conducted at Scientia Clinical Research in Sydney, Australia.

Multiple Phase 2 Studies to be Conducted in 2H 2022

Following completion of the Phase 1 study, Claritas will initiate several Phase 2 clinical studies across multiple clinical indications, including pulmonary arterial hypertension (“PAH”); persistent pulmonary hypertension of the newborn (“PPHN”); and COVID-related sepsis and COVID-related ARDS.

As the Company previously announced, R-107 has been evaluated in validated animal model studies of PAH and sepsis. The costs of these studies were funded through grants provided by the U.S. Department of Health and Human Services. The data from these studies in both PAH and sepsis are unprecedented in the scientific literature and suggest that R-107 is a potentially revolutionary new treatment for each of these diseases.

In the animal model study of PAH, R-107 was demonstrated to be the first and only drug to produce a durable reversal, or potential cure, of this lethal disease. 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 a proprietary drug 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.

Closing of First Tranche of Financing with Alumina Partners (Ontario) Ltd.

Effective January 27, 2022, the Company closed the initial tranche of CAD $150,000 under its previously announced financing agreement with Alumina. The terms of the initial tranche were as previously announced. The closing of the initial tranche was made on the conditional approval of the initial tranche by the TSX Venture Exchange (the “TSXV”). The company is seeking final approval from the TSXV with respect to this initial tranche and expects to receive such final approval shortly. The net proceeds from the initial tranche were spent primarily for costs associated with the Company’s Phase 1 clinical study of R-107.

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.

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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. The Company and its management’s expectations as to the results of any research or study, and the result of the application with HREC may or may not occur as currently expected. The timing of the receipt of the final TSXV approval for the initial tranche of the financing is outside Claritas’ control. 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 Information

Robert Farrell

President, CEO

(888) 861-2008

m

¹ Pulmonary Arterial Hypertension Market Size Worth $9.8 Billion By 2027, Grand View Research, February 2020