NPO Petrovax Pharm, the vaccine and pharmaceutical drug development company, today announces the publication of the interim analysis of data from the Company’s trial in the Drugs in Context journal. The trial tested Polyoxidonium®, Petrovax’s injectable formulation of the immunomodulator azoximer bromide (AZB) in 81 hospitalised COVID-19 patients. Positive top line results from the trial are herewith reported.
The open-labelled trial assessed the efficacy and safety of injected Polyoxidonium® as a therapy for patients hospitalised with COVID-19. In addition to standard of care treatment, patients received 12 mg of intravenous AZB (lyophilizate for solution for injections and topical application; NPO Petrovax Pharm) once daily for 3 days (days 0–2), followed by AZB 12 mg administered intramuscularly every other day for 13 days until discharge (days 4–16).
The primary outcome was change in clinical condition using the 7-point Ordinal Scale for Clinical Improvement (OSCI) on day 15, specified as the primary endpoint in the WHO Master Protocol. AZB was shown to be well tolerated and all patients were alive and discharged with normal oxygen saturations with no secondary infections or delayed mortality reported by the end-of-study visit (on day 28–72). A decrease in the mean OSCI and National Early Warning Score values was observed following treatment with AZB. A decrease in OS score was marked in patients identified as severe on recruitment.
“The publication of data from our trial in a peer reviewed journal, Drugs in Context, provides further validation for Polyoxidonium®, our polymeric compound with immune-modulating properties that has been used widely in Russia for over 20 years. We believe Polyoxidonium® could provide a much-needed treatment against COVID-19, and with the support of our team, input from the regulators and collaboration with our partners, we are now wholly focused on the completion of our Phase III trial programme”.
Mikhail Tsyferov, President of Petrovax
“The results confirm our belief that Azoximer bromide, a widely known drug approved for use in its injectable form for other indications, may have the potential as means of restoring the body’s immune response and accelerate recovery from COVID-19. This well characterised and exceedingly well tolerated drug supports the patient, boosting their defences rather than targeting specific viral mechanisms. This might carry additional advantages of treating COVID-19 infections caused by SARS-CoV-2 variants insensitive to antiviral drugs or infections that occur alongside infection by another respiratory virus such as influenza or respiratory syncytial virus that may well be encountered in possible future waves in infection proposed in for the winter of 2021-2022”.
Professor Jean-François Rossi, Professor of Hematology at the University of Montpellier and Senior
The full title of the publication is: “The effect of Azoximer bromide (Polyoxidonium®) in patients hospitalized with coronavirus disease (COVID-19): an open-label, multicentre, interventional clinical study”.