- Noxopharm has been granted official approval for the use of Veyonda® in hospitalised COVID-19 patients in Europe.
- The Company will now commence the Phase 1 NOXCOVID-1 study.
- The official approval represents an important medical milestone, with Veyonda® believed to be the first drug tested in COVID-19 patients that inhibits STING pathway.
- Noxopharm will enrol patients under NOXCOVID-1 study until late-October 2020, anticipating the release of study findings in early-2021.
- The Company remains in discussion with the US FDA regarding a possible clinical trial in the US, following the review of the NOXCOVID trial data.
Australian biotech, Noxopharm Limited (ASX:NOX) has announced an important milestone with formal approval for immediate initiation of Veyonda®’s clinical trial in COVID-19 patients in Europe.
Following the key update, the Company’s stock marked an uptick of ~5 per cent to $0.320 on 1 September 2020.
NOXCOVID-1 is a Phase 1 dose-expansion and dose-escalation study, which focuses on safety and proof-of-principle endpoints. The study targets patients who have been admitted to hospital for respiratory insufficiency (not requiring artificial ventilation) connected with the SARS-CoV-2 virus.
In June this year, Noxopharm notified about its plan to commence NOXCOVID clinical program with a Phase 1 trial in Europe, following regulatory approvals. Subsequent to the review, the expert panels have now granted the official approval to start this study in Europe.
Official Approval – An important Milestone
According to Noxopharm, the official approval represents an important medical milestone in being the first known use of a drug in COVID-19 patients that inhibits STING pathway. Excessive STING signalling is increasingly thought to be a leading cause of death and long-term disability in COVID-19 patients.
Noxopharm believes Veyonda® has potential to avert the progression of COVID-19 disease through the STING pathway into the phenomenon termed as a ‘cytokine storm’, resulting in septic shock. Consequently, the Company is in a position to put this theory into practice and possibly help to lessen the dreadful impact of this pandemic.
As per Noxopharm, it appears increasingly that the world is going to have to learn to live with the SARS-CoV-2 virus. This means that there will be a need for effective therapies to cope with ~5 per cent of patients who contract the virus and whose lung failure endangers them of developing a cytokine storm and its related serious clotting disorders.
Given the situation, Noxopharm expects the upcoming NOXCOVID-1 study to potentially place Veyonda® as a front-line therapy for these ~5 per cent of patients, irrespective of whether a safe and effective vaccine is developed.
Details of NOXCOVID-1 Study
The NOXCOVID-1 study will be conducted in around 40 COVID-19 patients admitted to hospitals of Ukraine and Moldova. Both these countries are presently facing high rates of COVID-19 infection and hospitalisation.
Noxopharm has planned to administer a range of doses of Veyonda® to COVID-19 patients, who are hospitalised with moderate symptoms and are at high risk of progressing into a cytokine storm and developing septic shock. While these patients are ill enough to require hospitalisation, they do not have such serious symptoms that they need mechanical ventilation or ICU care.
In the NOXCOVID-1 study, patients will be treated with Noxopharm’s Veyonda® for not less than 14 days and may obtain treatment for up to 28 days if needed. Additionally, the study will measure the following aspects:
- the safety and tolerability of the medication in patients with poor lung function,
- the drug’s ability to prevent patients from tipping over into a cytokine storm and septic shock, and
- the effect of treatment on blood cytokine levels that will be evaluated in an Australian laboratory.
Noxopharm has already completed training of the medical personnel at the study sites. With the recent receipt of official approval, supplies for the study are also being shipped without any delay. Commencing the NOXCOVID-1 study immediately, Noxopharm will enrol patients until late-October 2020, potentially releasing the study findings in early-2021.
Following the review of final NOXCOVID-1 data, Noxopharm will consider its next step. However, the Company continues to remain in discussion with the US FDA on carrying out a clinical trial in the US, with NOXCOVID-1 serving as a proof-of-principle, pilot study.