Soluble Ferric Pyrophosphate (SFP)

The Company’s lead bio-pharmaceutical product SFP is an investigational drug in Phase 2 clinical development and is designed to prevent and treat iron deficiency anemia in ESRD patients. While the human body needs iron, free iron is toxic and can cause inflammation, oxidative stress, allergic reactions including anaphylaxis, and death. Iron must be bound to another molecule, called a ligand, for safe transportation within the body. Pyrophosphate is an ideal ligand for iron as it is more tightly bound than any other iron – preventing the release of free iron; it is a natural, physiologic chelator of iron, an antioxidant and an inhibitor of vascular and soft tissue calcification.

Unlike current IV iron administration, SFP administered via dialysate is designed to avoid storage in the liver and travels directly to the bone marrow, delivering iron in a physiologic manner. SFP is expected to improve the effectiveness of iron delivery for the majority of dialysis patients and prevent iron induced liver damage, especially for those patients with known concomitant liver disease.

SFP is able to solubilize and travel directly to the blood stream, similar to the physiologic iron uptake from the ingestion of food. SFP is formulated for slow, continuous delivery by way of dialysate during every dialysis treatment. SFP is formulated to replace the iron that is lost during every dialysis treatment, providing the body with the iron it needs to form red blood cells and transport oxygen, and is expected to improve ESA response. Small, frequent doses of SFP, as compared to the current administration of large, infrequent doses of IV iron, have the potential to be safer and more effective in delivering and maintaining optimal iron balance.