Noxopharm (ASX:NOX) has announced that the latest formal review by the NOXCOVID-1 Safety Steering Committee has cleared it to advance to the fifth and final dosage cohort.
The independent committee voted unanimously to move to the 1800 mg dose after they reviewed the safety profile of Veyonda in 12 patients from cohorts three and four (involving 800 and 1200 mg Veyonda respectively).
The company said this as a highly encouraging outcome given the advanced nature of COVID-19 disease in these study patients, in particular suffering serious lung dysfunction.
It said it will be reporting formally on efficacy in due course, with the overall objective being to use Veyonda to block the cytokine release syndrome (so-called ‘cytokine storm’) that leads to patients requiring intensive care, and is a primary cause of the multi-organ damage responsible for much of the long-term disability and death in COVID-19 patients.
According to Noxopharm CEO Dr Graham Kelly, “Patients we are treating are at the stage of COVID-19 disease generally associated with high rates of deteriorating lung function requiring intensive care. While early days, the progress of the trial is serving to boost our confidence that Veyonda is capable of meeting its primary objective of blocking the cytokine release syndrome causing that rapid deterioration, and doing so in a well-tolerated and minimally-intrusive way.”
Dr Kelly continued, “Noxopharm sees a commitment to the NOXCOVID trial as adding considerable commercial value to Veyonda, apart from obvious humanitarian reasons. With an estimated 11 million deaths each year from septic shock, the need to block cytokine release syndrome effectively and safely goes well beyond the current pandemic with its estimated approximately 2 million deaths to date.
"While Veyonda remains the Company’s current spearhead drug in the septic shock field with a potential major role to play in the pandemic, our subsidiary Pharmorage in collaboration with Hudson Institute of Medical Research and the Australian National University is underway in developing a drug purpose-built for septic shock across all situations.”