Noxopharm to Initiate COVID-19 Trial Program in Europe, Continues Discussions with FDA

Summary

• Noxopharm to commence NOXCOVID clinical trial program in Europe, focusing on safety and proof-of principle endpoints of Veyonda^® as a possible treatment of septic shock.
• Veyonda^® has been found to hold a potential to block the formation of cytokine storm resulting in septic shock, responsible for around 10 million deaths across the world each year.
• With no effective treatment for septic shock currently in place beyond supportive intensive care, a successful treatment of septic shock represents a pressing humanitarian need and an enormous commercial opportunity for Noxopharm.

Australian clinical stage drug developer, Noxopharm Limited (ASX:NOX) notified in its latest update the commencement of NOXCOVID clinical trial program in Europe, focusing on safety and proof-of principle endpoints of Veyonda^® as a potential treatment of septic shock.

Following this update, NOX rallied by ~8 per cent, closing the trading session at $0.205 on 19^th June 2020. NOX last traded at $0.200 on 22^nd June 2020.

The NOXCOVID program is developed on the latest finding that idronoxil, the active ingredient in Veyonda^®, obstructs the STING signalling pathway, believed to be an important trigger of septic shock.

COVID-19 has underlined the lack of an effective treatment for septic shock, which is a common but severe problem that occurs when a patient’s body encounters serious tissue damage associated with bacterial and viral infections and trauma. In this condition, rather than the body repairing the damage, the repair process goes into overdrive creating further damage.

Moreover, septic shock is believed to be responsible for around 10 million deaths across the world each year or one in five deaths, exclusive of COVID-19 patients^1.

As Noxopharm’s Veyonda^® has been found in the laboratory to hold the potential to block the formation of cytokine storm resulting in septic shock, the Company intends to validate this potential in a clinical setting as quickly and as cost-effectively as it can.

Towards this objective, Noxopharm is continuing with its NOXCOVID program in two simultaneous paths:

• Commencement of Phase 1 study (NOXCOVID-1) in COVID-19 patients in Europe to provide crucial safety data and proof-of-principle of Veyonda^® in a cost-effective and timely way before committing to a significantly larger study.
• Progressing discussions with FDA towards obtaining IND (Investigational New Drug) approval for an expanded clinical trial in USA.

NOXCOVID Phase 1 trial to commence in Europe

Noxopharm is progressing its efforts towards a Phase 1 dose-escalation and dose-expansion study (NOXCOVID-1) in Europe, which will be conducted in up to ~40 patients admitted to hospital (not requiring artificial ventilation) for respiratory insufficiency associated with the SARS-CoV-2 virus.

The endpoints of the study comprise clinical responses, safety, tolerability and biomarker (cytokine) data.

Subject to regulatory approvals, Noxopharm will undertake its Phase 1 study in European countries - Ukraine and Moldova, which are facing an escalation in number of COVID-19 deaths and cases as the pandemic moves eastward within Europe. Noxopharm has identified three hospitals each in both of these countries and their respective intensive care specialists have responded enthusiastically to the opportunity to use Veyonda^®.

The process of attaining regulatory approval for the Phase 1 trial from local hospital ethics committees and central regulatory authorities is currently in progress, with Ukraine’s fast-track COVID-19 clinical trial approval process offering an advantage.

Noxopharm has appointed a UK-based contract research organisation, Clinical Accelerator, to supervise the trial while the Australian company, Datapharm, will process the data.

Role of Veyonda^® in COVID-19 Trial Program

Noxopharm’s Veyonda^® is targeting patients with moderate early-stage respiratory distress to avert progression into virally induced septic shock. Veyonda® is intended to prevent the inception of the cytokine storm which causes tissue damage in lungs along with other major organs.

The figure below demonstrates the biological rationale for the use of Veyonda^® in COVID-19 patients suffering from poor lung function, including patients with ARDS (acute respiratory distress syndrome) who are at risk of developing a cytokine storm:

Notably, Veyonda^® is not meant to replace other possible treatments like dexamethasone which can potentially provide a clinical benefit in patients already experiencing a cytokine storm. The key aim of Noxopharm’s trial is to confirm that Veyonda^® holds the ability to significantly reduce or block the development of the cytokine storm resulting in death of COVID-19 patients.

Discussions with FDA Continue for Approval on Expanded Clinical Trial in US

Noxopharm has obtained a prompt and extensive response from the FDA on its pre-IND submission lodged in May this year for Veyonda^® clinical trial in COVID-19 patients. Consequently, the Company has agreed to some recommended design changes in the clinical protocol, which has been configured acting on the advice of U.S., Australian and European clinicians, and integrating FDA guidance.

An expanded clinical trial in the US rests on the demonstration of safety and proof-of principle the Phase 1 trial, that is expected to provide the Company with all the required information to make key strategic decisions prior to committing to the funding of a larger trial.

Noxopharm believes its Phase 1 dose-escalation and dose-expansion study in Eastern Europe is likely to produce all critical safety and early proof-of-principle efficacy data in a far more cost-effective and timely manner than in the US.

According to Noxopharm, other key reasons to kick-start a clinical trial in Eastern Europe include:

• It should be possible to initiate a trial in Eastern Europe an estimated 4-5 months earlier than in the U.S.
• Per patient costs in the U.S. are projected at 4- 5 times more than in Eastern Europe.

With no current effective treatment for septic shock in place beyond supportive intensive care, a successful treatment for septic shock represents a pressing humanitarian need and an enormous commercial opportunity for Noxopharm. Besides proceeding with its COVID-19 clinical program, the Company is on track with its DARRT and LuPIN programs as primary opportunities in the oncology arena.