Claritas Announces Completion of Canine Toxicology Studies

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.