Claritas Announces Completion of IND-Enabling In Vitro Genotoxicity Studies with R-107
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.