- Claritas (KLY) has finalized in vitro genotoxicity studies with R-107, its candidate to treat vaccine-resistant COVID-19
- The genotoxicity studies were completed at Covance Laboratories under full Good Laboratory Practice compliance
- During the Ames Assay, R-107 did not induce mutations in any of five strains of Salmonella typhimurium
- During the in vitro micronucleus test, R-107 did not induce chromosome breaks and/or whole chromosome loss
- The Ames Assay and in vitro micronucleus tests confirm that R-107 does not have any carcinogenic ability
- Claritas Pharmaceuticals is a clinical-stage biopharmaceutical company focused on unmet medical needs
- Claritas Pharmaceuticals (KLY) is up 12.50 per cent and is currently trading at C$0.045 per share
Claritas (KLY) has finalized in vitro genotoxicity studies with R-107, its candidate to treat vaccine-resistant COVID-19.
The genotoxicity studies were completed at Covance Laboratories under full Good Laboratory Practice compliance, which is a prerequisite to Phase 1 clinical studies as per FDA guidelines.
The genotoxicity studies included assessing the potential mutagenic activity of R-107 in a bacterial reverse mutation assay, or Ames Assay.
The Ames Assay is a core component of the chemical safety assessment data required by regulatory agencies to register new drugs.
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.
During the in vitro micronucleus test, which is designed to detect genotoxic damage, R-107 did not induce micronuclei in cultured human peripheral blood lymphocytes following all treatments tested. The maximum concentration of R-107 analyzed was approximately 1 millimolar.
It was therefore determined that R-107 is unable to induce chromosome breaks and/or whole chromosome loss in this test system.
The data in both the Ames Assay and the in vitro micronucleus tests confirm that R-107 does not have any carcinogenic ability.
Robert Farrell, Claritas’ President and CEO, commented,
“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. 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.”
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.
Claritas Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for patients with significant unmet medical needs.
Claritas Pharmaceuticals (KLY) is up 12.50 per cent and is currently trading at C$0.045 per share as of 9:41 am ET.
