Noxopharm launches Phase I COVID-19 program in Europe

By Jenni Spinner contact

- Last updated on GMT

(peshkov/iStock via Getty Images)
(peshkov/iStock via Getty Images)

Related tags: COVID-19, Coronavirus, European union, Clinical trials

The drug development firm is exploring the viability of Veyonda as a potential treatment for cytokine storm and septic shock in diagnosed patients.

Australia-based drug development company Noxopharm has started its Noxocovid clinical program with a planned Phase I trial in Europe. The effort is geared toward gathering safety data and proof-of-principle regarding the use of Veyonda, a drug currently used to block cGAS-STING signaling.

The purpose of the trial is to determine Veyonda’s potential use as a treatment for cytokine storm and septic shock, both of which have emerged as significant causes of morbidities and death in COVID-19 patients.

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 CEO Graham Kelly told Outsourcing-Pharma that treatment of cytokine storm has proven a formidable challenge in the battle against COVID-19.

“Just as in diseases like rheumatoid arthritis, a cytokine storm involves out-of-control levels of multiple cytokines​,” he said. “In the case of COVID-19, about six cytokines have been identified as being prominent players; we only have current drugs for two of those cytokines​.”

Kelly added that both drugs used for cytokine storms have been tried on COVID-19 patients—unfortunately, with no reported benefit.

The challenge therefore appears to be the need to block the production of a wide range of cytokines​,” he explained.

According to Noxopharm, a more feasible approach may be to ‘go further upstream’ to target the cytokine storm at its source (likely the cGAS-STING pathway) is becoming increasingly seen as that headwater.

Septic shock, another condition common in COVID-19 patients, also occurs in patients suffering from a range of other conditions, Kelly told us.

Any virus (or bacteria) is capable of inducing septic shock; most deaths from seasonal influenza outbreaks are due to septic shock​,” he commented. “In the case of COVID-19 patients, the cytokine storm occurs in those patients who develop severe lung inflammation; this lowers their ability to absorb oxygen, with the resulting hypoxia causing damage to major organs such as the heart, liver, kidneys and brain​.”

“This extensive damage is what triggers an over-exuberant inflammatory response = cytokine storm,” Kelly explained.

Noxopharm announced in April that laboratory studies revealed 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.

Certain cancers (such as prostate cancer and colorectal have been associated with ‘bad’ inflammation and anti-inflammatory drugs (like prednisone) have been shown to be helpful in the treatment of those cancers. According to Noxopharm, encouraging clinical results using Veyonda in end-stage prostate cancer moved researchers to explore if this could be aid COVID-19 patients as an active inhibitor of the STING pathway.

Kelly told us the company is eager to test Veyonda’s effectiveness in treating COVID-19 patients, and protecting against cytokine storm and septic shock.

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​,” he said. “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​.”

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