Claritas Announces Completion of IND-Enabling Rodent Toxicology Studies with R-107
Claritas Pharmaceuticals, Inc. (KALTF) has completed GLP toxicology studies of R-107, a potential treatment for COVID-19 and other viral diseases. Conducted at Covance Laboratories, the studies showed R-107 was well tolerated at doses significantly exceeding the planned therapeutic dose in humans, providing over a 10-fold safety margin. These findings support R-107's regulatory path for injectable formulations and mark a critical step toward initiating Phase 1 clinical trials, anticipated later this year in Adelaide, Australia. The studies also confirmed a linear relationship between plasma levels and dosages of R-107.
- Completion of GLP toxicology studies for R-107 supports regulatory approval.
- R-107 showed a significant safety margin (over 10-fold) compared to the expected human dosage.
- Studies indicated a linear relationship between R-107 plasma levels and dosage, aiding in optimal dosing regimen planning.
- None.
SAN FRANCISCO and TORONTO, March 12, 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 toxicology studies of R-107 in rodents. Claritas is developing R-107 as a therapy for vaccine-resistant COVID-19, influenza, and other viral diseases.
The rodent toxicology 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, dedicated to advancing healthcare. Covance is FDA audited and approved to perform pre-clinical safety and toxicology studies.
The completion of these toxicology studies in rodents will provide appropriate regulatory support for injectable formulations of R-107, as well as for any oral or topical formulation of R-107 where the drug is absorbed into the blood and systemic exposure may consequently occur.
Data from Rodent Toxicology Studies are Strongly Positive
The rodent investigations at Covance evaluated three dose levels of R-107: 250, 400, and 600 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 addition, R-107 was also administered to rodents 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. Careful examination of the data collected in these studies revealed that administration of R-107 at all dose levels tested 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 10-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 rodent 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.
“The completion of this study moves us closer to the initiation of our Phase 1 clinical study,” stated Robert Farrell, Claritas’ President and CEO. “These toxicology studies in rodents are a key part of the mandatory GLP battery of studies necessitated by the FDA prior to the initiation of the Phase 1 clinical trial in human subjects that will be initiated later this year at CMAX in Adelaide, Australia.”
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.
- Website Home: https://claritaspharma.com/
- News and Insights: https://claritaspharma.com/news/
- Investors: https://claritaspharma.com/investors
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
FAQ
What are the results of the GLP toxicology studies for R-107 by Claritas Pharmaceuticals?
When will the Phase 1 clinical trial for R-107 start?
What is the significance of completing GLP toxicology studies for Claritas Pharmaceuticals?
How does R-107 work as a treatment?
What role did Covance play in the R-107 studies?
