Noxopharm (ASX:NOX) has announced the commencement of its NOXCOVID clinical program with a planned phase one trial in Europe.
The company said the trial is designed to provide safety data and proof-of-principle of Veyonda as a potential treatment of septic shock.
It said it is progressing its NOXCOVID program in two parallel paths - the phase one study and ongoing discussions with the US FDA towards a potential Investigational New Drug (IND) approval for an expanded clinical trial.
According to Noxopharm CEO Dr Graham Kelly, “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 creates 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.”
Dr Kelly continued, “We previously, on April 21 this year, announced that Veyonda works in the laboratory in a way that indicates the potential to block the formation of the so-called cytokine storm leading to septic shock. We need to confirm this in a clinical setting as quickly and as cost-effectively as we can. The implications for the Company in having a positively acting drug are very substantial and that is the main reason why we have chosen to run a Phase 1 study in Europe.”
The phase one NOXCOVID-1 is a dose-escalation and dose-expansion study focusing on safety and proof-of-principle endpoints (biomarker and clinical responses). It will be in up to approximately 40 patients who have been admitted to hospital for respiratory insufficiency (not requiring artificial ventilation) associated with the COVID-19 virus.
Dr Gisela Mautner, Noxopharm chief medical officer, said, “Intensive care doctors in Ukraine and Moldova have responded enthusiastically to the opportunity to use Veyonda given the case-loads they currently are experiencing. The key aim of this Phase 1 study is to confirm the safety of Veyonda in patients at risk of septic shock, and to confirm that Veyonda has the ability to block or considerably reduce the development of the cytokine storm contributing to the death of COVID-19 patients.”
The company has also lodged a pre-IND submission with the FDA for a trial in COVID-19 patients. The company said it has received a prompt and extensive response from the US regulator, confirming it has agreed to certain recommended design changes in the clinical protocol.
Dr Kelly added, “While Veyonda is first and foremost an anti-cancer drug, and we are pressing on with our DARRT and LuPIN programs as primary opportunities, a successful treatment of septic shock represents both an enormous commercial opportunity and a pressing humanitarian need that we cannot ignore.”