24 September 2021 - - US-based biotechnology and pharmaceutical company Reven Holdings, Inc has completed Part 1 of the Two-Part, Two Cohort Multi-Center Phase I/II trial of Reven's lead anti-sepsis drug candidate RJX in hospitalized high-risk COVID-19 patients, the company said.

12 hospitalized adult patients with symptomatic high-risk COVID-19 pneumonia and abnormally elevated inflammation markers in the blood were treated with daily intravenous infusions of RJX in combination with standard of care.

Nine of the 12 patients, including 3 patients with hypoxemic respiratory failure, showed rapid clinical recovery with normalization of the blood oxygen levels and abnormally elevated inflammation markers. They were discharged from hospital between 3-14 days (median = 5 days).

All patients tolerated their RJX infusions without any side effects, the company said.

An Independent Data and Safety Monitoring Board that oversees and acts independently of the Reven project team has reviewed the clinical data in all 12 patients, and approved the initiation of the randomized, double-blind Part 2 portion of the Phase 2 study.

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.

The FDA-approved clinical trial is aimed at evaluating the efficacy and safety of RJX as an adjunct to standard of care in hospitalized COVID-19 patients, who have high-risk features for progression to severe disease and ARDS and 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.

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 for human subjects.

These research results suggest that RJX has the potential to improve the treatment outcome of high-risk COVID-19 by preventing as well as reversing acute respiratory distress syndrome and its complications.

Rejuveinix is an intravenous formulation of physiologically compatible compounds that is being developed for more effective treatment of patients with sepsis, 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.

It is currently being evaluated as a COVID-19 drug candidate in high risk COVID-19 patients.

Reven Holdings, Inc., a Delaware corporation, through its Westminster, Colorado based operating company Reven, LLC, is a biopharmaceutical company.

Reven's vision is to make a difference in the world by making its products accessible to everyone suffering the effects of vascular and metabolic related diseases.

Reven is committed to being the premier, research-intensive biopharmaceutical company that advances the health and well-being of people around the world.

Its primary product, Rejuveinix, targets patients suffering from COVID-19, sepsis, vascular and metabolic related diseases as well as specific patient populations suffering from PAD and other cardiovascular related medical conditions.