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Be the first with the news that moves the market - Claritas (KLY) has completed rodent toxicology studies with R-107, its COVID-19 therapy
- The company is developing R-107 as a therapy for vaccine-resistant COVID-19, influenza and other viral diseases
- Animals subjects tolerated R-107 at all dose levels, potentially providing a ten-fold safety margin for human use
- Claritas Pharmaceuticals is a clinical-stage biopharmaceutical company focused on unmet medical needs
- Claritas Pharmaceuticals (KLY) is up 11.11 per cent and is currently trading at C$0.05 per share
Claritas (KLY) has completed rodent toxicology studies with R-107, its COVID-19 therapy.
R-107 is a liquid, nitric oxide-releasing molecular prodrug that can be administered by injection.
The company is developing it as a therapy for vaccine-resistant COVID-19, influenza and other viral diseases.
The rodent toxicology studies were completed at Covance Laboratories, which is considered to be the world’s premier comprehensive drug development company.
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. In addition, R-107 was also administered to rodents as a repeat daily injection for seven consecutive days, a length of time consistent with the anticipated duration of therapy in the clinical setting of COVID-19 infection.
The data revealed that the animals tolerated R-107 at all dose levels. Given that the intended therapeutic dose of R-107 in humans is only 10-15 milligrams per kilogram of body weight, the results are expected to provide at least a ten-fold safety margin for human use.
This level of safety margin substantially exceeds the standard requirement of regulatory agencies, such as the FDA.
These studies will provide regulatory support for injectable formulations of R-107, as well as for any oral or topical formulation where the drug is absorbed into the blood and systemic exposure may occur.
Claritas 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 11.11 per cent and is currently trading at C$0.05 per share as of 1:12 pm EST.