Claritas Anticipates Response from Australian Ethics Committee by February 18, 2022
Claritas Pharmaceuticals announced that the Australian Human Research Ethics Committee (HREC) will review its submission for the Phase 1 clinical study of R-107 on February 16, 2022. Approval is expected by February 18, 2022, allowing immediate enrollment of 40 subjects in the study assessing R-107's safety and tolerability. Following this, multiple Phase 2 studies will target conditions like pulmonary arterial hypertension and COVID-related complications. R-107 shows promising results in animal studies, supported by U.S. government funding.
- HREC approval is the final regulatory step before the Phase 1 study can begin.
- R-107 has shown potential as a revolutionary treatment in animal models for pulmonary arterial hypertension and sepsis.
- The proprietary drug has a strong patent portfolio in approximately 40 countries.
- None.
Ethics Committee Approval is Final Step Prior to Enrollment of Claritas’ Phase 1 Clinical Study of R-107
SAN FRANCISCO, CA and TORONTO, ON, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (TSX VENTURE: CLAS and OTC: KALTF) (the "Company" or "Claritas") today announced that the Australian Human Research Ethics Committee (HREC) will meet on February 16th to review the submission made by the Company for the Phase 1 clinical study of R-107. The Company expects to receive comments or approval from the HREC by February 18th. HREC approval is the final regulatory step prior to initiation of the study. Claritas will begin enrollment in the study immediately following receipt of HREC approval.
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.
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.
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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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 Information
Robert Farrell
President, CEO
(888) 861-2008
info@claritaspharma.com
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