Reven Holdings has dosed the first subject in the randomised, double-blind, multi-institutional Phase II clinical trial of its lead anti-sepsis drug candidate, RJX, in hospitalised increased-risk Covid-19 patients.
An intravenous (IV) formulation of a particular combination of anti-oxidant and anti-inflammatory ingredients, RJX is intended to treat inflammatory ailments.
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Recently, the company had concluded the first part of the two-part, two-cohort multicentre Phase I/II trial of RJX in Covid-19 patients.
It enrolled 12 adult patients with symptomatic increased-risk Covid-19 pneumonia who are admitted to the hospital. These subjects who also had high inflammation markers in the blood received a daily IV dose of RJX plus standard of care.
According to the findings, nine subjects had quicker clinical recovery with normalisation of the abnormally raised inflammation markers in the blood.
They got discharged from the hospital at a median of five days while the treatment was tolerated by all participants with no adverse events reported.
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By GlobalDataThe data was reviewed by an independent Data and Safety Monitoring Board (DSMB), which recommended commencing the randomised, double-blind part 2 segment of the Phase II trial.
The FDA-cleared controlled trial will assess the efficacy and safety of RJX versus placebo with subjects receiving the standard of care as an adjunct.
Topline results from the trial are anticipated by the end of this year.
Reven Global Medical Affairs executive vice-president and chief medical officer Fatih Uckun said: “We will diligently advance the clinical development of RJX and evaluate its clinical impact potential for Covid-19 patients.
In September 2021, Reven concluded the initial part of the Phase I/II trial of RJX which showed quick recovery in hospitalised Covid-19 patients at increased risk.
