Rejuveinix (RJX) / Reven Holdings - LARVOL DELTA

Evaluation of the potential of Rejuveinix plus dexamethasone against sepsis. (PubMed, Future Microbiol) - "The combination of RJX plus DEX was more effective than either agent alone, decreased the inflammatory cytokine responses and associated organ damage, and improved the survival outcome in mice. In the phase I clinical study, RJX plus DEX was well tolerated by COVID-19 patients."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Septic Shock

Tolerability and Efficacy of RJX in Patients With COVID-19 (clinicaltrials.gov) - P1/2 | N=237 | Active, not recruiting | Sponsor: Reven Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix (RJX). (PubMed, Biomed Pharmacother) - "Furthermore, both formulations showed profound protective activity in a mouse model of sepsis. In agreement with the PD evaluations in rats and their proposed mechanism of action, both RJX-P and RJX-B exhibited near-identical potent and dose-dependent anti-oxidant and anti-inflammatory activity in the LPS-GalN model of ARDS and multi-organ failure in mice."

Clinical • Journal • PK/PD data • Acute Lung Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Oncology • Pneumonia • Respiratory Diseases • Septic Shock

Reven Pharmaceuticals Reports a Promising Second Generation Formulation of Its Lead Anti-sepsis Drug Candidate Rejuveinix (RJX) (Businesswire) - "...Reven Pharmaceuticals team reports positive results regarding the safety and preclinical efficacy of a second generation formulation of its lead anti-sepsis drug candidate Rejuveinix (RJX)....The article reports exciting new data obtained using a robust animal model of sepsis, which provided the preclinical scientific proof of concept that the new formulation of RJX can markedly improve the survival outcome by preventing multiorgan injury and systemic inflammation. The new formulation was the result of state of the art lead optimization and process scale-up."

Preclinical • Infectious Disease • Novel Coronavirus Disease

Reven Holdings Announces First Patient Dosed in RPI015 Clinical Trial Evaluating RJX for High-risk COVID-19 (Businesswire) - "Reven today announced that the first patient has been dosed in the Phase I/II trial of RJX in high-risk COVID-19 patients...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."

Trial status • Infectious Disease • Novel Coronavirus Disease

Tolerability and Efficacy of RJX in Patients With COVID-19 (clinicaltrials.gov) - P1/2; N=237; Not yet recruiting; Sponsor: Reven Pharmaceuticals, Inc.

Clinical • New P1/2 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Tolerability and Efficacy of RJX in Patients With COVID-19 (clinicaltrials.gov) - P1/2; N=237; Recruiting; Sponsor: Reven Pharmaceuticals, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • PCR

Rejuveinix Shows a Favorable Clinical Safety Profile in Human Subjects and Exhibits Potent Preclinical Protective Activity in the Lipopolysaccharide-Galactosamine Mouse Model of Acute Respiratory Distress Syndrome and Multi-Organ Failure. (PubMed, Front Pharmacol) - P1 | " RJX showed a very favorable safety profile and tolerability in human subjects. It shows potential to favorably affect the clinical course of high-risk COVID-19 by preventing ARDS and its complications."

Journal • Acute Lung Injury • Acute Respiratory Distress Syndrome • Infectious Disease • Lung Cancer • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Septic Shock • IL6 • TNFA

Reven Pharmaceuticals Reports Positive Results Regarding the Clinical Safety and Preclinical Efficacy of Its COVID-19 Drug Candidate Rejuveinix (RJX) (Businesswire) - P1, N=76; NCT03680105; Sponsor: Reven Pharmaceuticals Inc.; "...Reven Pharmaceuticals team reports positive results regarding the clinical safety and preclinical efficacy of its COVID-19 drug candidate Rejuveinix (RJX)....No participant experienced clinically significant or serious side effects....RJX showed a very favorable clinical safety profile and tolerability....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."

Cytokine storm • P1 data • Preclinical • Infectious Disease • Novel Coronavirus Disease

Reven Pharmaceuticals Wins FDA Approval of Its IND Application for Treatment of COVID-19 With Rejuveinix (RJX) (Businesswire) - "Reven today announced that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application in connection with its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX)....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....The study will be performed at approximately 14 U.S. health centers treating COVID-19 patients....Reven anticipates topline data from the trial in the second quarter of 2021."

Cytokine release syndrome • Cytokine storm • IND • New P2 trial • P2 data • Infectious Disease • Novel Coronavirus Disease

Reven Strengthens Its Clinical Team With Three New Members (Businesswire) - "Reven is planning to initiate a randomized, double-blind, placebo-controlled, multi-institutional clinical trial of its lead anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19....'Our IND (Investigational New Drug) application package for COVID-19 is completed and we are planning to roll out our clinical program against COVID-19 in the coming month,' said Michael Volk, Director and Chief Strategy Officer of Reven."

New trial • Infectious Disease • Novel Coronavirus Disease

Reven’s Patented, First-in-Class Anti-inflammatory Treatment Platform for Sepsis on Track for Clinical Testing in COVID-19 Patients (Businesswire) - "Reven today announced that FDA has responded favorably to its Pre-IND application. Following the FDA guidance, as the next step Reven is planning to promptly submit an Investigational New Drug (IND) application and clinical protocol to the Agency. The clinical study will be a randomized, double-blind, placebo-controlled, multi-institutional trial comparing a combination of the standard of care with a placebo to a combination of the standard of care with RJX for the treatment of COVID-19."

Cytokine storm • FDA event • New trial • Infectious Disease • Novel Coronavirus Disease