Thursday November 12, 2020 0 comments
GOLDEN -- Reven Holdings, Inc. today announced publication of a peer-reviewed article in the prestigious medical journal, Frontiers in Pharmacology, Section: Respiratory Pharmacology.
In the publication, the Reven Pharmaceuticals team reports positive results regarding the clinical safety and preclinical efficacy of its COVID-19 drug candidate Rejuveinix (RJX).
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, the company said.
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 (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 U.S. 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 U.S. health centers treating COVID-19 patients. Reven anticipates topline data from the trial in the second quarter of 2021.
“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 the prevention of progression of COVID-19 and its faster resolution in high-risk patients,” said Fatih Uckun, Reven’s chief medical officer and chief scientific officer, who is the first author of the new article.
“Based on the role inflammatory cytokines as well as oxidative stress play in the multisystem inflammatory syndrome in children (MIS-C) with COVID-19, and the ability of RJX to suppress the production of the inflammatory cytokines, including IL-6, TNF-α, and TGF-β, we hypothesize that RJX will also emerge as a clinically useful adjunct to the available supportive of care in pediatric COVID-19 patients who develop MIS-C.”
“This new article emphasizes our commitment to advancing our anti-inflammatory and anti-oxidant treatment platforms to address unmet needs in COVID-19 therapy,” said Peter Lange, Reven’s CEO.
“In addition to rapidly advancing the clinical development of our lead anti-oxidant treatment platform RJX for COVID-19 related viral sepsis, we are 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,” said Michael Volk, Reven’s chief strategy officer.
“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,” said Brian Denomme, Reven’s president and COO.