11 November 2020 - - The medical journal, Frontiers in Pharmacology has published peer-reviewed article in which a team from US-based biotechnology and pharmaceutical company Reven Holdings, Inc reports positive results regarding the clinical safety and preclinical efficacy of its COVID-19 drug candidate Rejuveinix, the company said.

According to the publication, no participant experienced clinically significant or serious side effects in a double-blind, placebo-controlled, randomized, two-part, ascending dose-escalation Phase 1 study in 76 healthy volunteer human subjects.

Hence, RJX showed a very favorable clinical safety profile and tolerability. Furthermore, experiments 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 more than 10-times lower than its maximum tolerated and safe dose for human subjects.

Notably, RJX not only protected animals against death by preventing progression of severe systemic inflammation, but it also caused reversal of already established and otherwise invariably fatal systemic inflammation.

RJX is an intravenous formulation of a patented first-in-class pharmaceutical composition containing a specific mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis, multi-system inflammation, cytokine release syndrome, shock, ARDS, and multi-organ failure.

End of last month, the US Food and Drug Administration has approved the Investigational New Drug application for RJX as a potential treatment for COVID-19 patients.

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 hospitalized COVID-19 patients, including 186 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 begin immediately at approximately 14 US health centers treating COVID-19 patients. Reven anticipates topline data from the trial in the second quarter of 2021.

RJX is an intravenous formulation of a patented first-in-class pharmaceutical composition containing a specific mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with inflammatory disorders, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome.

The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers.

Reven Holdings, through its Golden/Colorado-based operating company Reven, LLC (d.b.a Reven Pharmaceuticals), is developing new drugs for difficult-to-treat diseases.

As a clinical stage biopharmaceutical company, Reven's overarching goal is to develop effective treatments for serious health conditions caused by infectious, inflammatory, cardiovascular, and metabolic diseases.

Its lead product, RJX, is being developed as a treatment platform against complications of COVID-19, sepsis, cardiovascular diseases, and diabetes.