Reven Holdings announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application in connection with its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) as a potential treatment for COVID-19 patients.

RJX is an intravenous (IV) formulation containing a specific mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for the treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis, multi-system inflammation, cytokine release syndrome (CRS), shock, ARDS, and multi-organ failure.

The FDA-approved clinical trial is a randomized, double-blind, placebo-controlled, multi-institutional Phase 2 study designed to evaluate the efficacy and safety of RJX in 249 hospitalised COVID-19 patients, including 186 patients with mild-moderate disease who have high-risk features for progression to severe disease and ARDS (Cohort 1) and 63 patients with hypoxemic respiratory failure receiving either non-invasive positive pressure ventilation (NIPPV) or high flow oxygen, who have not yet developed ARDS to require mechanical ventilation (Cohort 2). The study will be performed at approximately 14 US health centers treating COVID-19 patients.

In a recently published double-blind, placebo-controlled, randomized, two-part, ascending dose-escalation Phase 1 study in 76 healthy volunteer human subjects, RJX showed a very favourable safety profile and tolerability in human subjects. No participant developed serious adverse events or prematurely discontinued participation from the study.

Reportedly, recent studies in animal models of sepsis, cytokine storm, ARDS, and multiorgan failure, have provided the scientific proof of concept that RJX can both prevent as well as reverse acute lung and liver injury associated with sepsis and cytokine storm, and improve the survival outcome at a dose level that is >10-times lower than its maximum tolerated dose (MTD) for human subjects.

Furthermore, a combination of low dose RJX with dexamethasone, a drug commonly used as part of standard of care in high-risk COVID-19, protected 100 per cent of animals against death by both preventing progression of systemic inflammation and reversal of already established systemic inflammation in a model of invariably fatal sepsis, ARDS, and multiorgan failure. These research results suggest that RJX has the potential to improve the treatment outcome of high-risk COVID-19 by preventing acute respiratory distress syndrome (ARDS) and its complications.

“Since RJX is a potent anti-oxidant and anti-inflammatory agent that has been shown to reduce the tissue-level oxidative stress in multiple organs in animal models of severe systemic inflammation, shock, cytokine storm, and multiorgan failure, we are hopeful that it will contribute to prevention of progression of COVID-19 and its faster resolution in high-risk patients,” said Fatih Uckun, Chief Medical Officer and Chief Scientific Officer of Reven.

Dr Uckun added, “Based on the role inflammatory cytokines as well as oxidative stress in the multisystem inflammatory syndrome in children (MIS-C) associated with COVID-19, and the ability of RJX to suppress the production of the inflammatory cytokines, including IL-6, TNF-α, and TGF-β, we hypothesise that RJX will also emerge as a clinically useful adjunct to the available supportive of care in pediatric COVID-19 patients who develop MIS-C.”

Reven anticipates topline data from the trial in the second quarter of 2021.