Claritas Pharmaceuticals, Inc. 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.