Thursday April 29, 2021 0 comments
WESTMINSTER -- Reven Holdings, Inc. today announced the first patient has been dosed in the Phase I/II trial of RJX in high-risk COVID-19 patients (ClinicalTrials.gov Identifier: NCT04708340; https://clinicaltrials.gov/ct2/show/NCT04708340).
The subject was a hospitalized symptomatic COVID-19 patient with hypoxemia, pneumonia and abnormally elevated inflammation markers in the blood who rapidly responded to protocol therapy with normalization of the inflammation markers and resolution of his hypoxemia.
Following his fast clinical recovery, patient no longer required supplemental oxygen therapy or hospitalization and he was discharged home on day 5.
“We will diligently advance the clinical development of RJX and evaluate its clinical impact potential for COVID-19 patients,” said Fatih Uckun, Reven chief medical officer.
“This new trial emphasizes our commitment to advancing our anti-inflammatory and anti-oxidant treatment platforms to address unmet needs in COVID-19 therapy,” added Peter Lange, Reven CEO.
RJX is an intravenous (IV) 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 (CRS), 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.
Reven said 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 (https://www.frontiersin.org/articles/10.3389/fphar.2020.594321/abstract).
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% 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, Even said.
“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 Uckun.
“We are excited to roll out our clinical program against COVID-19,” said Michael Volk, Reven director and chief strategy officer.
“In addition to rapidly advancing the clinical development of our lead anti-oxidant treatment platform RJX for COVID-19 related viral sepsis, we are also dedicated to developing new and effective anti-oxidant treatment platforms that are rationally optimized for other forms of sepsis and difficult-to-treat inflammatory disorders.”
“Scientific data from multiple studies suggest a tremendous therapeutic potential for the RJX platform and provide the foundation for our optimism regarding the commercialization potential of RJX,” added Brian Denomme, Reven’s president and COO.