Claritas Announces Completion of IND-Enabling In Vitro Genotoxicity Studies with R-107
The genotoxicity studies were completed at Covance Laboratories, Inc., under full Good Laboratory Practice (GLP) compliance, which is a prerequisite to Phase 1 clinical studies according to FDA guidelines.
SAN FRANCISCO and TORONTO, April 01, 2021 (GLOBE NEWSWIRE) -- Claritas Pharmaceuticals, Inc. (formerly Kalytera Therapeutics, Inc.) (TSX VENTURE: KLY and OTC: KALTF) (the "Company" or "Claritas") today announced that it has completed GLP genotoxicity studies of R-107. Claritas is developing R-107 as a therapy for vaccine-resistant COVID-19, influenza, and other viral diseases.
The genotoxicity studies were completed at Covance Laboratories, Inc., under full Good Laboratory Practice (GLP) compliance, which is a prerequisite to Phase 1 clinical studies according to FDA guidelines. Covance was named the “Global Contract Research Organization (CRO) Company of the Year” in 2020 by Frost & Sullivan and is considered to be the world’s premier comprehensive drug development company. Covance is FDA audited and approved to perform pre-clinical safety and toxicology studies.
“Genotoxicity is one of the major concerns when developing a new drug, and we are thrilled to announce R-107 successfully passed these GLP studies, as required by the FDA,” said Robert Farrell, Claritas’ President and CEO. “We plan to use these important data to gain FDA approval for our planned Phase 1 clinical trial in human subjects that will be initiated this year at CMAX in Adelaide, Australia.”
No Evidence for R-107 genotoxic activity
The genotoxicity studies at Covance included assessment of the potential mutagenic activity of R-107 in a bacterial reverse mutation assay (Ames Assay), and its ability to cause chromosomal aberrations in an in vitro human lymphocyte micronucleus assay. The Ames Assay is the most acceptable screen for determining the mutagenic potential of new drugs. The bacterial mutagenicity data generated in an Ames Assay represent a core component of the chemical safety assessment data required by regulatory agencies for registration or acceptance of new drugs. The study protocol included 5 different bacterial strains and a range of concentrations of R-107, according to the recommended concentrations by current regulatory guidelines. R-107 did not induce mutations in any of the five strains of Salmonella typhimurium at all concentrations up to 5000 μg/plate, providing no evidence of any R-107 mutagenic activity in this assay system.
The in vitro micronucleus test detects genotoxic damage and provides a preferred alternative to the previously used chromosome aberration test for detection of aneugenic (whole chromosome) or clastogenic (chromosome breakage) damage, using micronuclei formation as a biological marker. Treatments of human lymphocyte cultured cells covering a broad range of concentrations of R-107, separated by narrow intervals, were performed in this study at Covance. R-107 did not induce micronuclei in cultured human peripheral blood lymphocytes following all treatments tested, with the maximum concentration analyzed approximately equivalent to 1 millimolar (recommended as a suitable maximum concentration for the in vitro micronucleus assay in accordance with current regulatory guidelines). It was therefore determined that R-107 is considered unable to induce chromosome breaks (clastogenicity) and/or whole chromosome loss (aneugenicity) in this test system.
The data in both the Ames Assay and the in vitro micronucleus test confirm that R-107 does not have any carcinogenic ability, which positively contributes to its safety profile and moves the drug closer to initiation of human clinical testing in a Phase I study.
R-107 is a Nitric Oxide-Releasing Molecule
R-107 is a liquid, nitric oxide-releasing molecular prodrug that can be administered by injection, in contrast to nitric oxide gas therapy which requires a special type of delivery device and complex administration by trained respiratory therapists. When administered by injection, R-107 is slowly hydrolyzed by the blood, thereby releasing its active payload, 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 to tissues throughout the body, allowing for a smooth delivery of the active drug over 24 hours following a single dose of R-107.
Professor Salvatore Cuzzocrea, a member of Claritas’ board of directors and President of the University of Messina and former President of the European Shock Society is working with Salzman Group and Claritas, and has read and approved of the scientific disclosure in this news release. Professor Cuzzocrea has deep expertise regarding the medical use of nitric oxide and nitric oxide donors, and has published more than 600 papers on nitric oxide. He has conducted research and experiments with nitric oxide and nitric oxide donors since 1994, and worked closely as an advisor with the Salzman Group team that designed and invented R-107.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure, or contain the Covid-19 (or SARS-2 Coronavirus) at this time.
About Claritas Pharmaceuticals
Claritas 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.
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Cautionary Statements
Neither 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 Information
Robert Farrell
President, CEO
(888) 861-2008
[email protected]
