Australian clinical-stage drug development company Noxopharm (ASX:NOX) has announced that its lead investigational candidate Veyonda has been approved to move into its second and final stage of the NOXCOVID-1 clinical trial.
The first part of the trial involved 26 patients. It was a dose-escalation arm testing the safety of increasing (400, 600, 800, 1,200, 1,800 mg) daily Veyonda dosages.
The company said the 1,800 mg was deemed by clinicians to be sufficiently well-tolerated in patients with moderate COVID-19 disease to become the preferred dose.
"The high tolerance of the drug by patients with very poor lung function provides further evidence of the safety of Veyonda in patients with acute illness," said the company in a statement.
The second part of the NOXCOVID-1 trial is starting to recruit a minimum of 10 and up to 15 patients with moderate to severe lung dysfunction. Patients will be treated for up to 14 days with a 1,800 mg Veyonda dose each day.
Veyonda is being tested for its ability to block the cytokine release syndrome (CRS), or cytokine storm, and thereby reduce long-term disabilities and death in COVID-19 patients.
CRS can lead to a life-threatening condition known as septic shock, associated with a broad range of long-term disabilities in both young and older patients, and death in severe cases.
It is a so-called ‘storm’ because of a sudden surge in the blood of dozens of pro-inflammatory chemicals known as cytokines, resulting in damaging levels of inflammation in blood vessels and major organs.
In the case of infection with the COVID-19 virus or other viruses such as the influenza virus, the trigger for CRS is virally-induced lung damage.
Veyonda is being tested for its ability to block the development of CRS in COVID-19 patients with moderate lung damage.
The company said the aim is to prevent their progression to mechanical ventilation and ICU care, the development of a range of long-term disabilities identified as being associated with COVID-19 disease, and death.
Noxopharm CEO, Dr Graham Kelly, said, “The high potency of Veyonda in blocking cytokine release from damaged tissue in the laboratory meant we were obliged to adopt a very cautious and methodical approach when being used for the first time in patients with poor lung function. We can now be confident that Veyonda, despite its potency, is well tolerated at a dosage we believe will be therapeutic.
"What marks Veyonda as a highly promising drug prospect, where many other drugs have failed in this quest, is its ability to block the release of a wide range of these cytokines. Many of these other drugs block individual cytokines. In the face of surging levels of large numbers of cytokines, it is rational to think that the more cytokines a treatment can block, the better the outcome is likely to be in CRS.
"Moving onto Part 2 of the trial represents an important step towards our goal of seeing Veyonda become an effective and safe treatment of septic shock, not just in COVID-19 patients, but as one of the most common causes of human death from infections and severe trauma.”