Reven Holdings Announces Successful Completion of the First Part of RPI015 Clinical Trial Evaluating Its Lead Anti-sepsis Drug Candidate RJX in Hospitalized High-risk COVID-19 Patients

WESTMINSTER, Colo.–(BUSINESS WIRE)–Reven Holdings, Inc. (“Reven”) is a privately held clinical stage biotechnology and pharmaceutical company dedicated to the discovery and development of novel treatment platforms for cancer, viral illnesses – including COVID-19 – and inflammatory disorders.

Reven today announced the successful completion of Part 1 of the Two-Part, Two Cohort Multi-Center Phase I/II trial of Reven’s lead anti-sepsis drug candidate RJX in hospitalized high-risk COVID-19 patients (ClinicalTrials.gov Identifier: NCT04708340; https://clinicaltrials.gov/ct2/show/NCT04708340).

12 hospitalized adult patients with symptomatic high-risk COVID-19 pneumonia and abnormally elevated inflammation markers in the blood were treated with daily intravenous infusions of RJX in combination with standard of care. Nine (9) of the 12 patients, including 3 patients with hypoxemic respiratory failure, showed rapid clinical recovery with normalization of the blood oxygen levels and abnormally elevated inflammation markers. They were discharged from hospital between 3-14 days (median = 5 days). All patients tolerated their RJX infusions without any side effects.

An Independent Data and Safety Monitoring Board (DSMB) that oversees and acts independently of the Reven project team has reviewed the clinical data in all 12 patients, and approved the initiation of the randomized, double-blind Part 2 portion of the Phase 2 study.

“We will diligently advance the clinical development of RJX and evaluate its benefit for COVID-19 patients,” said Fatih Uckun, MD PhD, the Chief Medical Officer of Reven. “This randomized trial emphasizes our commitment to advancing our anti-inflammatory and anti-oxidant treatment platforms to address unmet needs in COVID-19 therapy,” added Peter Lange, the CEO of Reven.

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 FDA-approved clinical trial is aimed at evaluating the efficacy and safety of RJX as an adjunct to standard of care in hospitalized COVID-19 patients, who have high-risk features for progression to severe disease and ARDS and 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.

Recent studies 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 >10-times lower than its maximum tolerated dose (MTD) for human subjects (https://www.frontiersin.org/articles/10.3389/fphar.2020.594321/abstract). These research results suggest that RJX has the potential to improve the treatment outcome of high-risk COVID-19 by preventing as well as reversing acute respiratory distress syndrome (ARDS) and its complications.

“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 prevention of progression of COVID-19 and its faster resolution in high-risk patients with viral sepsis,” said Fatih Uckun, MD PhD, Chief Medical Officer and Chief Scientific Officer of Reven.

Michael Volk, Director and Chief Strategy Officer of Reven, stated, “We are excited to move to the next stage in the clinical program against COVID-19. In addition to rapidly advancing the clinical development of our lead anti-oxidant treatment platform RJX for COVID-19 related viral sepsis, we are also dedicated to developing new and effective anti-oxidant treatment platforms that are optimized for other forms of sepsis and difficult-to-treat inflammatory disorders.”

“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.

About Rejuveinix (RJX)

RJX is an intravenous (IV) formulation of physiologically compatible compounds that is being developed for more effective treatment of patients with sepsis, including COVID-19 patients with viral sepsis and acute respiratory distress syndrome (ARDS). The clinical safety and tolerability of RJX was confirmed in a recently completed double blind, placebo-controlled Phase 1 dose-escalation study in healthy volunteers (ClinicalTrials.gov Identifier: NCT03680105). It is currently being evaluated as a COVID-19 drug candidate in high risk COVID-19 patients (ClinicalTrials.gov Identifier: NCT04708340; https://clinicaltrials.gov/ct2/show/NCT04708340).

About Reven Holdings, Inc.

Reven Holdings, Inc., a Delaware corporation, through its Westminster, Colorado based operating company Reven, LLC, is a biopharmaceutical company. Reven’s vision is to make a difference in the world by making its products accessible to everyone suffering the effects of vascular and metabolic related diseases. Reven is committed to being the premier, research-intensive biopharmaceutical company that advances the health and well-being of people around the world. Its primary product, Rejuveinix (RJX), targets patients suffering from COVID-19, sepsis, vascular and metabolic related diseases as well as specific patient populations suffering from PAD and other cardiovascular related medical conditions.

Reven’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “on-track”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various disease indications. Each of these forward-looking statements involves risks and uncertainties, and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing market competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates, and unexpected litigation or other disputes. These risks are not exhaustive; the company faces known and unknown risks, including the risk factors described in the company’s periodic SEC filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information regarding future events, or otherwise.

Contacts

Michael Volk, Chief Strategy Officer

[email protected]