Thursday, April 29, 2021
WESTMINSTER — Reven Holdings, Inc. introduced immediately that the primary affected person has been dosed within the Phase I/II trial of RJX in high-risk COVID-19 sufferers (ClinicalTrials.gov ID: NCT04708340; https://clinicaltrials.gov/ct2/present/NCT04708340).
The topic was a hospitalized symptomatic COVID-19 affected person with hypoxemia, pneumonia and abnormally elevated inflammatory markers within the blood who responded shortly to protocol remedy with normalization of inflammatory markers and restoration from his hypoxemia.
After his speedy scientific restoration, the affected person didn’t require supplemental oxygen remedy or hospitalization and was discharged dwelling on day 5.
“We will diligently advance the clinical development of RJX and evaluate its clinical impact potential for COVID-19 patients,” mentioned Fatih UckunReven chief medical officer.
“This new study highlights our commitment to improving our anti-inflammatory and anti-oxidant treatment platforms to address unmet needs in COVID-19 therapy,” added Peter LongCEO of Reven.
RJX is an intravenous (IV) formulation of a proprietary premium pharmaceutical composition containing a particular mix of antioxidant and anti inflammatory components that’s being developed for simpler remedy of sufferers with inflammatory circumstances, together with COVID-19 sufferers with viral sepsis, multisystem irritation, cytokine launch syndrome (CRS), shock, ARDS and multi-organ failure.
The FDA-cleared scientific trial goals to judge the efficacy and security of RJX as an adjunct to the usual of care in hospitalized COVID-19 sufferers with high-risk traits for development to extreme illness and ARDS and sufferers with hypoxemic respiratory failure who both non-invasive constructive strain air flow (NIPPV) or excessive move oxygen, who haven’t but developed ARDS to require mechanical air flow.
Reven mentioned current research in animal fashions of sepsis, cytokine storm, ARDS and multi-organ failure have offered scientific proof that RJX can each stop and reverse acute lung and liver damage related to sepsis and cytokine storm, and enhance survival outcomes at a dose degree >10 instances. is under the utmost tolerated dose (MTD) for human topics (https://www.frontiersin.org/articles/10.3389/fphar.2020.594321/summary).
In addition, a mix of low-dose RJX with dexamethasone, a drug generally used as a part of commonplace of care in high-risk COVID-19, protected 100% of animals from loss of life by each stopping the development of systemic irritation and to reverse pre-existing systemic irritation. irritation in a mannequin of always-fatal sepsis, ARDS and multi-organ failure.
These research outcomes recommend that RJX has the potential to enhance the remedy consequence of high-risk COVID-19 by stopping acute respiratory misery syndrome (ARDS) and its problems, Even mentioned.
“Since RJX is a potent antioxidant and anti-inflammatory agent that has been shown to reduce tissue-level oxidative stress in multiple organs in animal models of severe systemic inflammation, shock, cytokine storm and multi-organ failure, we hope that it will contribute to the prevention of progression of COVID-19 and its faster resolution in high-risk patients,” mentioned Uckun.
“We are excited to roll out our clinical program against COVID-19,” mentioned Michael Volkdirector Reven and chief technique officer.
“In addition to rapidly advancing the clinical development of our leading antioxidant treatment platform RJX for COVID-19-related viral sepsis, we are also committed to developing novel and effective antioxidant treatment platforms rationally optimized for other forms of sepsis and difficult-to-treat inflammatory conditions.”
“Scientific data from multiple studies suggest tremendous therapeutic potential for the RJX platform and are the basis for our optimism regarding RJX’s commercialization potential,” added Brian Denomme, Reven’s president and COO.
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Source: www.innovationews.com