Such good news it bears repeating, .06 Monday, yes 2021-04-01 07:19 PT - News Release
Mr. Robert Farrell reports
CLARITAS ANNOUNCES COMPLETION OF IND-ENABLING IN VITRO GENOTOXICITY STUDIES WITH R-107
Claritas Pharmaceuticals Inc. (formerly Kalytera Therapeutics Inc.) has completed GLP (good laboratory practice) 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 GLP compliance, which is a prerequisite to phase 1 clinical studies according to U.S. Food and Drug Administration (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 preclinical 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, president and chief executive officer of Claritas. "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 five 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 5,000 micrograms per plate, providing no evidence of any R-107 mutagenic activity in this assay system.
The in vitro micronucleus test detects genotoxic damage and provides a preferred alternative to the previously used chromosome aberration test for detection of aneugenic (whole chromosome) or clastogenic (chromosome breakage) damage, using micronuclei formation as a biological marker. Treatments of human lymphocyte cultured cells covering a broad range of concentrations of R-107, separated by narrow intervals, were performed in this study at Covance. R-107 did not induce micronuclei in cultured human peripheral blood lymphocytes following all treatments tested, with the maximum concentration analyzed approximately equivalent to one millimolar (recommended as a suitable maximum concentration for the in vitro micronucleus assay in accordance with current regulatory guidelines). It was therefore determined that R-107 is considered unable to induce chromosome breaks (clastogenicity) and/or whole chromosome loss (aneugenicity) in this test system.
The data in both the Ames assay and the in vitro micronucleus test confirm that R-107 does not have any carcinogenic ability, which positively contributes to its safety profile and moves the drug closer to initiation of human clinical testing in a phase 1 study.