Australian oncology drug specialist Noxopharm (NOX:ASX) is looking to seek approval to test its Veyonda drug on COVID-19 patients in the US after it was revealed to contain an active ingredient that may significantly help in the treatment of the deadly virus.
The move follows the discovery by the Hudson Institute of Medical Research about a novel mode of action of idronoxil, the active ingredient in Veyonda, which holds potential to block STING signaling, which in some COVID-19 patients is thought to contribute to lethal self-destruction of major organs.
Noxopharm CEO, Graham Kelly, said the company is in the position of having a clinic-ready drug candidate to test the potential value of blocking STING signalling in COVID-19 patients.
With the emerging possibility that an abnormally high STING response is a factor in COVID-19 death, having an inhibitor of STING signalling ready to be tested in COVID-19 patients is both a considerable responsibility and opportunity,” Mr Kelly said.
“Proving the value of Veyonda to COVID-19 patients is both a humanitarian and regulatory approval opportunity that we cannot overlook.
“The need to prevent the phenomena of cytokine storm and septic shock in COVID-19 patients looks likely to remain for some considerable time, and may even remain a long-term need should development of an effective vaccine prove challenging.”
However, Mr Kelly added that for Noxopharm, Veyonda is first and foremost an oncology drug, with end-stage prostate cancer remaining its primary focus. Any clinical studies in non-oncology patients will require non-dilutive funding, something that the company believes in the current environment should be achievable once it receives the go-ahead to conduct a clinical study.
Mr Kelly said Noxopharm is currently moving to obtain guidance from the FDA on the appropriate regulatory approval pathway to pursue in the U.S. in relation to COVID-19 patients. The company also is pursuing the option of testing Veyonda in patients suffering septic shock from a range of infective agents other than the SARS-CoV-2 virus.
Noxopharm has been developing an oral dosage formulation of idronoxil for some time and the company originally considered using an oral dosage form in non-oncology patients. However, under advice, the company will proceed instead with Veyonda, given that product’s current Investigational New Drug (IND) status in the U.S., on top of the considerable clinical experience and data amassed with this dosage form.
The provisional patent lodged in relation to use in septic shock patients covers broad drug dosage forms including oral and suppository.