SAN FRANCISCO and TORONTO, March 17, 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 toxicology studies of R-107 in canines. On March 12, 2021, Claritas announced strongly positive data from toxicology studies in rodents, and today the Company is announcing equally positive data from toxicology studies in dogs.
These canine toxicology studies were performed by Covance Laboratories, Inc., under full Good Laboratory Practice (GLP) compliance, which is an FDA prerequisite to initiation of Phase 1 clinical studies in humans. Covance is considered to be the world’s premier comprehensive drug development company, is FDA audited and approved to perform pre-clinical safety and toxicology studies and was named the “Global Contract Research Organization (CRO) Company of the Year” in 2020 by Frost & Sullivan.
The completion of these toxicology studies in dogs will provide appropriate regulatory support for both injectable and oral formulations of R-107, as well as for any topical formulations of R-107 where the drug may be absorbed into the blood and systemic exposure may consequently occur.
Claritas is currently developing R-107 as a therapy for vaccine-resistant COVID-19, as well as for the treatment of influenza, and other viral diseases.
“Prior to initiation of Phase 1 clinical studies in humans, the FDA requires a number of GLP studies to be performed in animals. The positive results in the canine toxicology studies that we are announcing today, together with the positive results in the rodent toxicology studies that we announced last week satisfy the FDA requirements for safety toxicology studies in both species that are a prerequisite for initiating Phase 1 studies in humans and for registration for the market,” stated Robert Farrell, Claritas’ President and CEO.
Data from Canine Toxicology Studies are Strongly Positive
The canine studies at Covance evaluated four dose levels of R-107: 60, 75, 90, and 150 milligrams per kilogram of body weight given daily as a singular intramuscular injection, the same route of administration that is planned for the initial clinical studies in humans. In addition, R-107 was also administered as a repeat daily injection for 7 consecutive days, a length of time consistent with the anticipated duration of therapy in the clinical setting of COVID-19 infection. At all dose levels tested, R-107 was well tolerated by the animals. Given that the intended therapeutic dose of R-107 in humans is only 10-15 milligrams per kilogram of body weight, the results of these completed toxicology studies are expected to provide at least a 5-fold safety margin for human use. This level of safety margin substantially exceeds the standard requirement of regulatory agencies, such as the FDA.
In addition, the canine studies successfully measured the plasma levels of R-107 and its metabolites, including the therapeutically active payload metabolite, R-100. The plasma levels of both R-107 and R-100 were found to be linearly related to the dose level of R-107, a correlation that will simplify the selection of the optimal dosing regimen when the drug reaches the stage of clinical testing.
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, 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
info@claritaspharma.com