Reven has concluded the initial part of the Phase I/II clinical trial of its lead anti-sepsis drug candidate, RJX, which showed rapid recovery in hospitalised Covid-19 patients at increased risk.
RJX is an intravenous (IV) formulation of a peculiar combination of anti-oxidant and anti-inflammatory ingredients.
It is being developed as a potential therapy for patients with sepsis, including Covid-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS).
Part one of the two-part, two-cohort, multicentre trial enrolled 12 hospitalised adult patients with symptomatic high-risk Covid-19 pneumonia and abnormally raised inflammation markers in the blood.
Subjects were given daily IV doses of RJX plus standard of care.
Findings showed that nine out of the 12 subjects, including three with hypoxemic respiratory failure, demonstrated quick clinical recovery with normalisation of the blood oxygen levels and abnormally raised inflammation markers.
These subjects were discharged from the hospital between three to 14 days with a median of five days.
Furthermore, RJX infusion was well tolerated in all subjects, with no side effects reported in the trial.
On reviewing the clinical data from 12 subjects, the Independent Data and Safety Monitoring Board (DSMB) granted approval to commence the randomised, double-blind part two portion of the Phase II study.
Reven chief medical officer and chief scientific officer Fatih Uckun 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 septic 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 with viral sepsis.”
Latest studies in animal models of sepsis, cytokine storm, ARDS and multiorgan failure, offered scientific proof of concept that RJX can prevent and reverse acute lung and liver injury linked to sepsis and cytokine storm.
The drug also showed to enhance the survival outcome at a dose level more than ten times lesser than its maximum tolerated dose for humans.