- Drug developer Noxopharm (NOX) is set to kick off a phase one clinical trial to test its Veyonda drug’s ability to treat COVID-19 patients in Europe
- The drug was initially created as a cancer treatment but was proven to have the ability to treat some severe respiratory conditions relating to septic shock
- Given septic shock is a key issue for critial-condition COVID-19 patients, the drug is now set to be tested on roughly 40 coronavirus patients in Europe
- At the same time, Noxopharm is in discussion with the U.S. Food and Drug Administration to get Veyonda approved as an Investigational New Drug
- Based on the results of the new European trial, Noxopharm will make the call to commit to and fund a much larger clinical trial
- Shares in the company are trading almost eight per cent higher this afternoon, currently worth 20 cents each
Drug developer Noxopharm (NOX) is set to kick off a phase one clinical trial to test its Veyonda drug’s ability to treat COVID-19 patients in Europe.
Veyonda was originally created as an anti-cancer drug, but it was soon revealed that the product can treat some severe respiratory conditions relating to septic shock. As it happens, these conditions were identified as key issues for critical-condition COVID-19 sufferers, causing Noxopharm to throw its hat in the ring to find a coronavirus treatment.
The company is now progressing the NOXCOVID clinical trial in Europe. The key purpose of the first phase of the trial is to confirm the safety and proof-of-principle of Veyonda.
The first phase of the trial is a dose-escalation and dose-expansion study which will test roughly 40 coronavirus patients who have severe enough symptoms to need to be admitted to hospital, but not severe enough that they need artificial ventilation.
As long as Noxopharm lands some necessary regulatory approvals, it plans to conduct the studies in Ukraine and Moldova, where there has been a strong interest in the study from intensive care specialists in the area.
How does Veyonda treat COVID-19?
In April, Noxopharm revealed how Veyonda has the potential to block a body phenomenon known as a cytokine storm, which leads to septic shock.
Noxopharm CEO Dr Graham Kelly explained that septic shock is a potentially-lethal condition wherein 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 creates even more damage,” Dr Graham explained.
“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,” he said.
Veyonda’s ability to block the cytokine storm that leads to this condition has been confirmed in a laboratory, and Dr Graham said the company is now working to confirm this in a clinical setting as quickly and cost-effectively as possible.
FDA discussions
At the same time, Noxopharm is in ongoing discussions with the U.S. Food and Drug Administration (FDA) to get Veyonda approved as an Investigational New Drug (IND). This will allow for an expanded clinical trial in the States.
While the company has lodged a pre-IND submission with the FDA, Noxopharm said the opportunity to begin a study in Europe has led to the decision to “carve-out” the dose-escalation and dose-expansion arms of the proposed U.S. study.
Noxopharm said it would be able to get the trial underway between four and five months earlier in Europe than in the U.S. and at a fraction of the cost.
Looking ahead, Noxopharm said a lot hangs in the balance of the current trial. The future of the Veyonda program rests on the proof-of-concept and safety results from the Phase I trial, after which Noxopharm can make the call to commit to and fund a larger trial.
Shares in the company are trading 7.89 per cent higher this afternoon, currently worth 20 cents each.