Diabetic Foot Ulcers (DFUs)
It is estimated that of the 28 million diabetics in the United States, between 5% to 7% of them will develop a diabetic foot ulcer (DFU) every year, indicating that 1.4 million to 2 million people per year could need treatment of an ulcer. Many of these foot ulcers will not heal due to a lack of blood perfusion in the skin of diabetics. Previous Phase II US clinical trial data established that FGF-1 is a potent healer of diabetic foot ulcers, accelerating their healing and in one study, completely healing 100% of the ulcers treated with no adverse events noted. Zhittya believes its treatment for diabetic foot ulcers addresses an “unmet medical need” and could qualify for the US FDA designation as “Medical Breakthrough Therapy”.
About 1%, or 3.2 million Americans, have venous skin ulcers and they are more common in older, people particularly women. Venous ulcers usually affect the lower legs and one out of 50 people over the age of 80 in the US have these painful ulcers. The results from a previous US FDA-cleared Phase II clinical trial indicated that human FGF-1 enhanced the healing of venous ulcers. In that study, a two-fold acceleration of healing was demonstrated and the drug was well tolerated. Zhittya will now seek to build on these earlier results to develop FGF-1 for the treatment of those very painful, chronic wounds, which if not healed can lead to wound infection and tissue loss.