Noxopharm (ASX:NOX) has lodged a pre-Investigational New Drug (pre-IND) submission with the US FDA for a clinical trial of its Veyonda in patients with COVID-19 infection.
The company said the submission is based on a response to a package submitted to the FDA summarising the rationale for conducting a clinical trial with an inhibitor of cGAS-STING signalling.
It said, based on the current COVID-19 pandemic, a pre-IND can be converted into a fully expedited IND approval for relevant therapies. This reduces the time and complexity of the FDA review process.
Veyonda has a mechanism of action Noxopharm believes marks it as a prospective treatment of septic shock in COVID-19 patients.
Pre-clinical research conducted by the Hudson Institute of Medical Research has shown that one of the anti-cancer mechanisms of action of idronoxil - the active ingredient in Veyonda - is potent inhibition of the cGAS-STING signalling pathway.
The cGAS-STING signalling pathway is responsible for alerting the body’s immune system to the presence of an invading virus by triggering the production of cytokines. This pathway is important to generating an immune response that contributes to the great majority of COVID-19 patients recovering uneventfully. However, in a small proportion of patients who develop breathing problems leading to low oxygen levels, tissue damage in major organs triggers a second and excessive wave of cGAS-STING signalling, resulting in a so-called ‘cytokine storm’, amplifying existing tissue damage and inducing blood clotting problems.
A number of COVID-19 clinical trials are being conducted with drugs inhibiting individual components of the ‘cytokine storm’ such as IL-6 and TNF -alpha.