Noxopharm Ltd’s (ASX:NOX) interim data on its NOXCOVID trial points to Veyonda® providing protection against the progression of severe inflammation associated with a worsening of the disease in patients with moderately severe COVID-19.
The clinical-stage drug development company said the data supported the international patent application lodged on March 30, 2021, adding that the provisional patent was now a potentially very valuable commercial asset.
This is a key step in the potential development of Veyonda® as a treatment for septic shock responsible for an estimated 10 million deaths per year.
Shares of the company rose almost 10% higher intra-day to A$0.69 following the news while the market capitalisation is approximately $175.7 million.
‘Potentially highly valuable and much sought after asset’
Noxopharm chief executive officer Graham Kelly said: ”The world is facing an enormous challenge in vaccinating enough people to achieve global herd-immunity in the face of waves of emerging mutant strains of the virus.
“Until we successfully meet that challenge, millions of people are likely to continue to suffer severe COVID-19 disease involving major disabilities and death.
“That is where we see Veyonda® playing a key role, with its STING blocking action stopping the inflammatory process in patients with moderate COVID-19 disease moving from having a positive effect, to being seriously self-destructive."
He said: “The interim data released today points to Veyonda® delivering on this promise.
Treatments that stop patients progressing into needing high-level health care such as mechanical ventilation and occupying ICU beds is a major industry goal.
“Our confidence is growing that Veyonda® will form part of meeting that goal, and in so doing, potentially save many lives and deliver shareholders a potentially highly valuable and much sought after asset.”
Putative protective effect of Veyonda®
Associate professor Michael Gantier of Hudson Institute of Medical Research said: “While further correlations with clinical data are essential to gain a full picture, the fact that none of the inflammatory biomarkers progressed in these cohorts of moderately sick COVID-19 patients is aligned with a putative protective effect of Veyonda®.”
A key factor associated with disease worsening is the excessive production of inflammatory factors normally invoked to facilitate tissue repair and combat infection in a process known as the cytokine storm.
A number of these inflammatory factors has been described as biomarkers of the severity of COVID-19 disease, based on increased levels in COVID-19 patients at the start of the infection and further increases occurring with a worsening of their disease.
The current analyses involved a large panel of biomarkers associated with inflammation, coagulation and sepsis, in particular including those biomarkers linked to a worsening of COVID- 19.
The analyses were conducted in the first 18 COVID patients enrolled in the study on blood samples collected on days 1, 3, 7, 14 and 28 of treatment.
The analysis showed that those biomarkers associated with worsening COVID-19 disease, notably IL-1b, IL-4, IL-6, IL-10, TNF-a, CRP and D-dimer, did not rise in any of the 18 patients, including falling in a number of patients.
While correlation of these responses with clinical data will soon be underway, these interim findings point to a protective effect of Veyonda® against disease progression and the development of a cytokine storm.
Inhibition of STING signalling
Noxopharm, in collaboration with Hudson Institute of Medical Research, has discovered that Veyonda® has potent anti-inflammatory properties through the inhibition of STING signalling, a signalling pathway thought to fuel toxic inflammation and tissue damage in patients with low oxygen level.
While further studies are ongoing to implicate this pathway, the observation that none of the key biomarkers identified as being associated with increasing severity of COVID-19 disease, were increased after initiation of Veyonda® treatment, is consistent with the anti-inflammatory effects of Veyonda®.
Major scientific interest
The use of a drug that blocks STING signalling in COVID-19 is of major scientific interest because of the putative key role of STING in triggering a cytokine storm.
Veyonda® is the first drug to reach the clinic that blocks the STING signalling pathway, marking the NOXCOVID trial as an important test of this theory.
Noxopharm is pleased to note that today’s interim analysis is consistent with a role for STING signalling in COVID-19 disease and thereby a potential important role for Veyonda® in the ongoing management of the pandemic.
The company lodged an international patent application on the use of Veyonda® to prevent the cytokine storm and septic shock in virally-induced diseases, based on pre-clinical data.
Today’s interim human data confirms the pre-clinical data and substantiates the provisional claims.
The patent application provides the company with a potentially highly valuable asset that Noxopharm expects with confirmatory clinical data to be keenly sought after within the industry.
The biomarker data from the top Veyonda® (1,800 mg) dose cohort is expected within the next few weeks.
That will be followed by a review of the final clinical data on completion of treatment of the final patient.
Clinical status (WHO COVID-19 grade, co-morbidities) and other therapies will need to be taken into account.
After reviewing all data, the company will consult with its medical and business development advisors along with government bodies including drug regulators.