Noxopharm, a clinical-stage Australian drug development company, has announced commencement of its NOXCOVID clinical program with a planned Phase I trial in Europe.

This action is designed to provide important safety data and proof-of-principle of using Veyonda, a drug that blocks cGAS-STING signaling, as a potential treatment of the cytokine storm and septic shock that have emerged as major causes of morbidities and death in COVID-19 patients.

Dr. Graham Kelly, Noxopharm CEO, said, “Septic shock is a lethal condition that occurs when the body experiences severe tissue damage associated with viral and bacterial infections and trauma. Instead of the body repairing the damage, the repair process goes into overdrive and the resulting excessive inflammatory and immune responses create even more damage. Apart from COVID-19 patients, septic shock is thought to be responsible for about ten million deaths worldwide every year, or one in five deaths. COVID-19 simply has brought to the fore the lack of an effective treatment for this very common but severe problem.”

In April, Noxopharm announced that laboratory studies revealed that one of the mechanisms of action of idronoxil, the active ingredient in Veyonda, is to block the cGAS-STING signaling pathway, including the overexuberant STING and cytokine response to the sort of hypoxic tissue damage associated with low body oxygen levels in COVID-19 patients suffering severe respiratory distress.

A cytokine storm involves an over-abundance in the blood of multiple proteins known as pro-inflammatory cytokines. Inhibiting single cytokine members of that storm has to date not proved effective in preventing COVID-19 deaths. Noxopharm believes a more rational approach is to go further upstream and target the cytokine storm at its headwaters, thereby potentially modifying the production of the broad range of incriminating cytokines. The cGAS-STING pathway is becoming increasingly seen as that headwater.

“The purpose of this Phase I study is to test this theory in a clinical setting as quickly and as cost-effectively as we can,” said Dr. Kelly. “While Veyonda is first and foremost an anti-cancer drug, a successful treatment of septic shock represents both an enormous commercial opportunity and a pressing humanitarian need that we cannot ignore.”