Anti-inflammatory COVID recovery by an additional day.
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 had recently submitted a Pre-Investigational New Drug (Pre-IND) application to the U.S. Food and Drug Administration (FDA) to obtain feedback and guidance for its clinical evaluation of the anti-inflammatory/anti-oxidant investigational drug product Rejuveinix (RJX) in the treatment of COVID-19. 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. The clinical trial design, mechanism of action and the rationale for developing RJX as a treatment modality for prevention of cytokine storm and other complications of COVID-19 are all discussed in a published article in the current issue (Volume 10, Issue 3, 2020) of the peer-reviewed medical journal Clinical Investigation: