19 June 2020
- NOX proceeding with its COVID-19 clinical program in Europe while discussions with FDA continue
- Phase 1 trial aiming to confirm proof-of-principle and safety of Veyonda® in a timely and cost-effective way before committing to a considerably larger study
- End-points include safety, tolerability, clinical responses and biomarker (cytokine) data
- Targeting patients with moderate respiratory distress to prevent progression into virally-induced septic shock
- Based on anti-inflammatory effects of Veyonda as first-in-class inhibitor of the STING pathway
Noxopharm (NOX) announces commencement of its NOXCOVID clinical program with a planned Phase 1 trial in Europe. This action is designed to provide important safety data and proof-of-principle of Veyonda as a potential treatment of septic shock before committing the Company to a major study.
Noxopharm is progressing its NOXCOVID program in two parallel paths :-
1 . Initiation of a Phase 1 study (NOXCOVID-1) in COVID-19 patients in Europe to provide key safety and clinical evidence of proof-of-principle cost-effectively;
2. Continuing discussions with FDA towards gaining Investigational New Drug (IND) approval for an expanded clinical trial in USA
Dr Graham Kelly, Noxopharm CEO, said, “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.”
“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.”
NOXCOVID-1
NOXCOVID-1 is a Phase 1 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 SARS-CoV-2 virus. UK-based contract research organisation, Clinical Accelerator, has been appointed to oversee the trial, and Australian company, Datapharm, will process the data. A clinical protocol has been designed acting on the advice of Australian, U.S. and European clinicians, and incorporating FDA guidance.
Veyonda is intended for patients with early-stage respiratory disease who are at risk of developing a cytokine storm and septic shock. The aim is to prevent the onset of the cytokine storm that inflicts tissue damage in the lungs and other major organs. Veyonda is not intended to replace other potential treatments like dexamethasone that may provide a clinical benefit in patients with mode advanced disease already experiencing a cytokine storm.
Subject to regulatory approvals, NOXCOVID-1 will be conducted in Ukraine and Moldova, where there is a rising number of COVID-19 cases and deaths as the pandemic moves eastward across Europe. Three hospitals in Ukraine and three in Moldova have been identified and their respective intensive care specialists have indicated strong interest in participating.
The process of obtaining regulatory approval for the trial from central regulatory authorities and local hospital ethics committees is underway. Ukraine has an expedited COVID-19 clinical trial approval process.
Dr Gisela Mautner, Noxopharm CMO, 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.”
Read the full media release.
