7 July 2020 - - US-based clinical stage biotechnology and pharmaceutical company Reven Holdings, Inc is highlighting the publication two peer-reviewed expert articles authored by its chief medical officer and chief scientific officer, Fatih Uckun M.D. Ph.D., and other members of the Reven team and their academic collaborators in the medical journal, Clinical Investigation (London), the company said.

Dr. Uckun provides an overview of the development status, mechanism of action, and clinical potential of the RJX platform for the treatment of COVID-19 in the article, "Clinical Impact Potential Of Rejuveinix For Prevention Of Fatal Acute Respiratory Distress Syndrome And Multi-Organ Failure In COVID-19 Patients."

The article also discusses the potential for the prevention of life-threatening complications from COVID-19 with RJX based on data obtained from clinical and non-clinical studies. This has provided the medical-scientific rationale for Reven's clinical development strategy for RJX and a randomized, double-blinded clinical study in COVID-19 patients.

One of the crucial questions with regard to COVID-19 seems to be the prevention of progression of mild disease. Kristina Cabala explains how RJX could favorably affect the patient journey in the article, "Rationale for a randomized, placebo-controlled, Phase 2 study of Rejuveinix in COVID-19 patients with acute lung injury and hypoxemic respiratory failure." She provides the critical design elements for a two-cohort, two-part placebo-controlled, double-blind Phase 2 study of RJX in COVID-19 patients.

In addition to the possible prevention of progression of mild disease, the paper discusses how RJX could have a positive impact on the faster resolution of ARDS, prevention of multiple-organ failure, and a reduction of case mortality during respiratory failure.

The article also describes how RJX could potentially promote long-term healing after patient recovery from COVID-19.2

RJX is an intravenous formulation of known physiologically compatible compounds that is being developed for more effective supportive therapy of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome.

The RJX formulation is a solution of buffered acid products, electrolyte components, and vitamins, including ascorbic acid, cyanocobalamin, thiamine hydrochloride, riboflavin 5' phosphate, niacinamide, pyridoxine hydrochloride, and calcium d-pantothenate, and magnesium sulfate heptahydrate, a mineral with a negative oxidation-reduction potential.

The components of RJX exhibited promising activity in clinical studies involving ARDS patients and/or non-clinical studies in animal models of ARDS.

The published data from these clinical and non-clinical studies provided the medical-scientific rationale for Reven's clinical development strategy for RJX and a clinical study in COVID-19 patients. The clinical tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105).