Sigyn Therapeutics, Inc. reported the successful completion of an in vivo animal study that demonstrated Sigyn Therapy to be safe and well tolerated. Sigyn Therapy is a novel blood purification technology designed to perform functions that are beyond the reach of drugs and overcome the limitations of current devices to treat life-threatening inflammatory conditions, including sepsis, the leading cause of hospital deaths. Data resulting from the in vivo study will be incorporated into an Investigational Device Exemption (IDE) that the Company plans to submit to the U.S. Food and Drug Administration (FDA) to support the potential initiation of human clinical studies.

In the study, an adult version of Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of up to six hours in eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The study was comprised of a pilot phase (two subjects), which evaluated the feasibility of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansion phase (six subjects) to further assess treatment safety and refine pre-treatment set-up and operating procedures. Overall, Sigyn Therapy was well tolerated by all eight animal subjects and no serious adverse events were reported in any treated animal. Important criteria for treatment safety – including hemodynamic parameters, serum chemistries and hematologic measurements – were stable across all subjects.

Of the eight treatments, seven were administered for the entire six-hour treatment period. One treatment was halted early due to the observation of a clot in the device, which was believed to be the result of a procedural deviation from the device priming instructions in the pre-treatment set-up. In another treatment, a decrease in activated clotting time values to below prescribed levels resulted in additional anticoagulant dosing during a completed six-hour treatment.

No serious adverse events were observed in either of these two treatments. In parallel with conducting these in vivo studies, the Company reported the completion of in vitro blood plasma studies that validated the ability of Sigyn Therapy to address a broad-spectrum of relevant therapeutic targets, which included endotoxin (gram-negative bacterial toxin); peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia, bile acid & bilirubin); CytoVesicles (extracellular vesicles that transport inflammatory cargos); and tumor necrosis factor alpha (TNF alpha), interleukin-1 beta (IL-1b), and interleukin 6 (IL-6), which are pro-inflammatory cytokines whose dysregulated production can induce sepsis and other life-threatening inflammatory conditions.