Reven Pharmaceuticals Reports a Promising Second Generation Formulation of Its Lead Anti-sepsis Drug Candidate Rejuveinix (RJX)

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 sepsis, cancer, viral illnesses, including COVID-19 – and inflammatory disorders.

Reven today announced the publication of a peer-reviewed article in the prestigious medical journal, Biomedicine and Pharmacotherapy. In this new publication, 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).

RJX is an intravenous (IV) formulation of a patented first-in-class pharmaceutical composition containing a specific proprietary mixture of anti-oxidant and anti-inflammatory ingredients that is being developed for more effective treatment of patients with sepsis and inflammatory disorders, including COVID-19 patients with viral sepsis, multi-system inflammation, cytokine release syndrome (CRS), shock, ARDS, and multi-organ failure.

Sepsis represents a strong inflammatory response to an infection with a potentially fatal outcome due to its complications, including acute respiratory distress syndrome (ARDS), septic shock, multiple organ dysfunction syndrome (MODS), and disseminated intravascular coagulopathy. The composition, mode of action, and recently published favorable clinical safety profile of RJX make it an attractive anti-inflammatory drug candidate for the prevention and treatment of sepsis.

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.

Reference for the Publication:

Fatih M. Uckun, Cemal Orhan, Joy Powell, Emre Sahin, Ibrahim H. Ozercan, Michael Volk, Kazim Sahin, Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix (RJX), Biomedicine & Pharmacotherapy, Volume 141, 2021,111823, ISSN 0753-3322, https://doi.org/10.1016/j.biopha.2021.111823.

Reven recently completed a Phase 1, double-blind, placebo-controlled, randomized, two-part, ascending dose-escalation study that demonstrated its safety and tolerability in healthy volunteers (Protocol No. RPI003; ClinicalTrials.gov Identifier: NCT03680105). RJX is being evaluated for its potential for prevention and treatment of COVID-19 associated viral sepsis in a placebo-controlled, double-blind Phase II study (Protocol No. RPI015; ClinicalTrials.gov Identifier: NCT04708340). The ongoing 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.

“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 sepsis, we are hopeful that it will contribute to prevention of progression of systemic inflammation and its faster resolution in septic patients, including COVID-19 patients with viral sepsis,” said Fatih Uckun, MD PhD, Executive Vice President, Head of Clinical and Medical Affairs and Chief Scientific Officer of Reven.

Michael Volk, Director and Chief Strategy Officer of Reven, stated “We are excited about the new formulation of RJX as a potent anti-oxidant treatment platform that is rationally optimized for sepsis and difficult-to-treat inflammatory disorders.”

“We will try to diligently advance the clinical development of RJX and its new formulation”, said Peter Lange, Chief Executive Officer of Reven. “This new formulation emphasizes our commitment to developing our anti-inflammatory and anti-oxidant treatment platforms to address unmet needs in health care,” added Brian Denomme, President of Reven. “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,” he added.

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: NCT 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]