Beyond the Reach of Drug Therapies
To treat life-threatening infections and inflammatory disorders that are not addressed with approved drugs, we created Sigyn Therapy to extract pathogen sources of life-threatening inflammation in concert with dampening down the dysregulated overproduction of inflammatory cytokines (the cytokine storm), which play a prominent role in each of our candidate treatment indications.
Based on an unprecedented ability to isolate and extract viral pathogens, bacterial toxins, and inflammatory cytokines from the bloodstream, Sigyn Therapy is a candidate to treat pathogen-associated sepsis (leading cause of hospital deaths), community acquired pneumonia (a leading cause of death among infectious diseases), emerging pandemic threats, and hyperinflammation & endotoxemia that commonly occurs in end-stage renal disease patients.
Since initiating Sigyn Therapy development in 2020, we completed a series of in vitro studies that demonstrated the ability of Sigyn Therapy to extract pathogen sources of inflammation from human blood plasma. These include endotoxin (a gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins), and viral pathogens, including COVID-19.
We also completed studies that demonstrated the ability of Sigyn Therapy to extract inflammatory cytokines from human blood plasma. These include interleukin-1 beta (IL-1b), interleukin-6 (IL-6), and tumor necrosis factor alpha (TNF-a). In a related study, we reduced the circulating presence of 104 nanometer liposomes as a model to evaluate the potential of Sigyn Therapy to address CytoVesicles that transport inflammatory cytokine cargos throughout the bloodstream.
Additionally, we validated the rapid reduction of hepatic (liver) toxins from human blood plasma, which included ammonia, bile acid and bilirubin. Based on these outcomes, we may further investigate the potential of Sigyn Therapy to address acute and chronic forms of liver failure.
Subsequent to our in vitro milestone achievements, we completed in vivo animal studies at the University of Michigan, which demonstrated Sigyn Therapy to be well tolerated. In the studies, Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods up to six hours in eight porcine (pig) subjects. Important criteria for treatment safety, including hemodynamic parameters, serum chemistries and hematologic measurements, were stable across all eight subjects.
We plan to incorporate the data resulting from our in vivo and in vitro studies into an Investigational Device Exemption (IDE) that we are drafting for submission to the U.S. Food and Drug Administration (“FDA”) to support the potential initiation of human studies in the United States.
Sigyn Therapy Highlights
- Sigyn Therapy is a single-use disposable device designed for deployment on the established infrastructure of hemodialysis and continuous renal replacement machines located in hospitals and clinics around the world.
- Sigyn Therapy has an immense capacity to extract bloodstream targets as it incorporates a formulation of adsorbent components that provide more than 200,000 square meters (~50 acres or 37 American football fields) of surface area on which to adsorb and remove bloodstream targets.
- Sigyn Therapy is also highly efficient, as a patient’s entire circulatory system can pass through the device more than 15-times during a four-hour treatment.
- Unlike devices that concentrate therapeutic targets in the blood-path, Sigyn Therapy isolates and extracts therapeutic targets from the bloodstream to eliminate continued blood cell interactions during treatment.