Australian drug development company Noxopharm Limited(ASX: NOX) has commenced a clinical study of Veyonda in COVID-19 patients.
Following review by expert panels, official approval has been granted for immediate commencement of the Phase 1 NOXCOVID-1 study. This is an important milestone for the company as well as representing an important medical milestone in being the first known use of a drug in COVID-19 patients that inhibits a target (STING pathway) increasingly being incriminated as a leading cause of death and long-term disability in these patients.
Dr Gisela Mautner, Noxopharm’s Chief Medical Officer, said the companybelieves Veyonda has the potential to prevent the progression of COVID-19 disease via the STING pathway into the phenomenon known as a ‘cytokine storm’ leading onto septic shock.
NOXCOVID-1 will involve approximately 40 COVID-19 patients in hospitals in Ukraine and Moldova, two countries currently experiencing high rates of infection and hospitalisation.
A range of doses of Veyonda will be administered to patients hospitalised with moderate symptoms who are at high risk of tipping over into a cytokine storm and developing septic shock.
Typically, these patients are sick enough to require hospitalisation, but do not yet have such severe symptoms that they require ICU care or mechanical ventilation.
Patients will be treated with Veyonda for at least 14 days and may receive treatment for up to 28 days if required. The safety and tolerability of the medication in patients with poor lung function will be measured, as well as the drug’s ability to prevent patients progressing into a cytokine storm and septic shock. One of the key endpoints is the effect of treatment on blood cytokine levels, which will be assayed in an Australian laboratory.
Training of the medical personnel at the study sites has been completed and now that approval has been granted, supplies for the study are being shipped without delay. The study will commence immediately and patients will be enrolled until late-October 2020. Findings of the study are anticipated to be released in early-2021.
Dr Mautner added,
“This is an important step in potentially bringing to market a medication that could reduce the devastating worsening lung function and multi-organ failure that afflicts a number of COVID-19 sufferers”.
“There is growing scientific evidence that excessive STING signalling is behind the cytokine storm causing severe disease and even death in COVID-19 patients.
“Therefore, the company is excited to be in a position to put this theory into practice and hopefully help to reduce the terrible impact of this pandemic.”