Sigyn Therapeutics, Inc. announced that it plans to pursue first-in-human feasibility studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Inflammation and endotoxemia are prevalent conditions associated with increased mortality in dialysis dependent ESRD patients. According to the United States Renal Data System (USRDS), there are more than 550,000 individuals with ESRD, which results in approximately 85 million dialysis treatments being administered in the United States each year.

At present, there are no approved drugs to treat ESRD related inflammation and endotoxemia. In this regard, Sigyn Therapy offers a candidate strategy to improve the health and quality-of-life of ESRD patients. In the Company's proposed study, Sigyn Therapy will be combined in series with enrolled subjects regularly scheduled dialysis treatment.

Sigyn Therapy is broad-spectrum blood purification technology that isolates and extracts pathogen sources of life-threatening inflammation in concert with the depletion of proinflammatory cytokines from the bloodstream. In addition to evaluating the safety of Sigyn Therapy in health compromised ESRD patients, the Company plans to quantify changes in circulating levels of endotoxin (gram-negative bacterial toxin) and inflammatory cytokines including, tumor necrosis factor-a (TNF-a), interleukin-1b (IL-1-b), and interleukin-6 (IL-6) before and after each administration of Sigyn Therapy. Previously conducted in vitro studies have validated the ability of Sigyn Therapy to address each of these therapeutic targets, which are also associated with sepsis (leading cause of hospital deaths worldwide), community-acquired pneumonia (a leading cause of death among infectious diseases) and emerging pandemic threats.

Based on its disclosed intent to enroll ESRD patients, the Company is updating an Investigational Device Exemption (IDE) that it drafted for submission to the U.S. Food and Drug Administration (“FDA”) related to the potential initiation of human feasibility studies. However, there is no assurance that human feasibility or pivotal studies will demonstrate Sigyn Therapy to be a safe and efficacious treatment for any candidate treatment indication. The Company further reported that it has downgraded its clinical interest in treating hepatic encephalopathy and other liver-associated disorders at this time.