Energenesis Biomedical announced on 18th that its new drug ENERGI-F703, a topical gel for diabetic foot ulcers, is under development and will be tested in a Phase III human clinical trial in the United States, and is actively seeking licensees.

Yesterday, Energenesis received notification from a CRO (Clinical Commissioned Research Organization) that its new drug ENERGI-F703, a topical gel for diabetic foot ulcers, has been submitted to the US Food and Drug Administration (FDA) for a Phase III clinical trial (IND) in humans in the United States, as it has passed the 30-day review period and is eligible to commence trials in the US.

According to the 2018 IQ4I Research & Consultancy market survey, the global prevalence of diabetes is about 5.5% and the diagnosis rate is about 50%, with 25% of diabetic patients developing diabetic foot ulcers. According to the company, based on the global average prevalence rate of 6.3%, the number of diabetic foot ulcers in the diabetic community is 14 million per year, and about 20% of diabetic foot ulcer patients face amputation.

Although Johnson & Johnson's (J&J) Regranex is licensed by the US FDA to treat diabetic foot ulcers, the FDA announced in June 2008 that the use of Regranex for more than 3 conditions may increase the risk of death for cancer patients.

The Phase II clinical trial of the new Chinese drug ENERGI-F703 in the US and Taiwan showed an average wound size of 6.9 square centimetres, which exceeds the average wound size treated by known molecular drug companies worldwide. The trial results were also accepted for publication at the American Academy of Diabetes Medicine (ADA 2021).

More information please visit www.energenesis-biomedical.com