Reven Pharmaceuticals Wins FDA Approval of Its IND Application For the Treatment of COVID-19 With Rejuveinix (RJX)

Published : 24 Oct 2020

Drug Name: Rejuveinix

Reven Holdings, Inc. could be an in private control clinical-stage biotechnology and pharma dedicated to the invention and development of novel treatment platforms for cancer, infectious agent illnesses—including COVID-19—and inflammatory disorders.

Reven these days proclaimed that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application about its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) as a possible treatment for COVID-19 patients.

RJX is an associate blood vessel (IV) formulation of a proprietary first-in-class pharmaceutical composition containing a selected mixture of anti-oxidant and anti-inflammatory ingredients that are being developed for the simpler treatment of patients with inflammatory disorders, together with COVID-19 patients with infectious agent infection, multi-system inflammation, protein unleash syndrome (CRS), shock, ARDS, and multi-organ failure.

The FDA-approved test could be a randomized, double-blind, placebo-controlled, multi-institutional part two study designed to judge the effectiveness and safety of RJX in 249 hospitalized COVID-19 patients, together with 186 patients with mild-moderate unwellness United Nations agency have insecure options for progression to severe unwellness and adult {respiratory distress syndrome|ARDS|wet lung|white lung|respiratory disease|respiratory illness|respiratory disorder} (Cohort 1) and sixty-three patients with hypoxemic respiratory failure receiving either non-invasive positive pressure ventilation (NIPPV) or high flow O, United Nations agency haven't however developed respiratory illness to want mechanical ventilation (Cohort 2). The study is performed at close to fourteen U.S. health centers treating COVID-19 patients.

In a recently printed double-blind, placebo-controlled, randomized, two-part, ascending dose-escalation part one study (ClinicalTrials.gov Identifier: NCT03680105) in seventy-six healthy volunteer human subjects, RJX showed an awfully favorable safety profile and tolerability in human subjects. No participant developed serious adverse events or untimely discontinued participation from the study.

Recent studies in animal models of infection, protein storm, ARDS, and multiorgan failure, have provided the scientific proof of construct that RJX will each stop furthermore as reverse acute respiratory organ and liver injury related to infection and protein storm, and improve the survival outcome at a dose level that's >10-times below its most tolerated dose (MTD) for human subjects (https://www.frontiersin.org/articles/10.3389/fphar.2020.594321/abstract).

Furthermore, a mixture of low dose RJX with anti-inflammatory, a drug normally used as a part of normal care in insecure COVID-19, protected 100 percent of animals against death by each preventing progression of general inflammation and reversal of already established general inflammation in a very model of invariably fatal infection, ARDS, and multiorgan failure. These analysis results recommend that RJX has the potential to enhance the treatment outcome of insecure COVID-19 by preventing acute metabolic process distress syndrome (ARDS) and its complications.

“Since RJX could be a potent anti-oxidant and anti-inflammatory agent that has been shown to scale back the tissue-level aerobic stress in multiple organs in animal models of severe general inflammation, shock, protein storm, and multiorgan failure, we tend to are hopeful that it'll contribute to the hindrance of progression of COVID-19 and its quicker resolution in insecure patients,” aforementioned Fatih Uckun, MD Ph.D., Chief medical practitioner and Chief Scientific Officer of Reven. Dr. Uckun added: “Based on the role inflammatory cytokines furthermore as aerobic stress within the multisystem inflammatory syndrome in youngsters (MIS-C) related to COVID-19, and therefore the ability of RJX to suppress the assembly of the inflammatory cytokines, together with IL-6, TNF-a, and TGF-ß, we tend to suppose that RJX also will emerge as a clinically helpful adjunct to the obtainable corroborative of care in medical specialty COVID-19 patients United Nations agency develop MIS-C.”

Michael Volk, Director and Chief Strategy Officer of Reven, stated, “We are excited to roll out our clinical program against COVID-19. additionally, to quickly advancing the clinical development of our lead anti-oxidant treatment platform RJX for COVID-19 connected infectious agent infection, we tend to {are also|also ar|are} dedicated to developing new and effective anti-oxidant treatment platforms that are rationally optimized for different varieties of infection and difficult-to-treat inflammatory disorders.”

“We have assembled an excellent team for a booming execution of our FDA-approved COVID-19 study. we'll attempt to diligently advance the clinical development of RJX and measure its clinical impact potential for COVID-19 patients,” aforementioned Peter photographer, Chief officer of Reven. “This new IND emphasizes our commitment to advancing our medication and anti-oxidant treatment platforms to deal with unmet wants in COVID-19 medical aid,” he added.

Reven anticipates topline knowledge from the trial within the second quarter of 2021.

Source: GlobalData.com