RPHE-3917: Diabetic Foot Ulcer Treatment

Rophe Pharma is engaged in the process of generating data in order to obtain intellectual property rights for a topical treatment for diabetic foot ulcer. The RPHE-3917 treatment will consist of the use of two already approved products in a topical formulation (cream or ointment) that will be applied to the area of the skin where the foot ulcer is located. Only three products have been approved to date by the Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers. These include two bioengineered skin-care products, Apligraf and Dermagraft (Organogenesis), but both are expensive. Apligraf is produced from cultured cells taken from neonatal foreskin and Dermagraft is derived from human neonatal dermal fibroblasts. In contrast to these approved treatments, our product is extremely cost effective and also easy to use. The experimental data obtained so far demonstrates remarkable results in the treatment of foot ulcers using RPHE-3917 and we are also on the way to developing a patentable topical formulation.

According to Market and Markets, the global wound-care market is expected to reach USD 20.4 Billion by 2021 from USD 17.0 Billion in 2016, growing at a CAGR of 3.6% from 2016 to 2021. The market for diabetic foot ulcer is $3-6 billion worldwide and is expected to grow between 6-10% CAGR over next 5 years. Rophe Pharma's plan is to first develop the product for treatment of diabetic foot ulcers in which the product is expanded for treatment of other wound types that would also include surgical, traditional wound types, acute (burns), end user (hospital, inpatient, and outpatient), long-term care, and home healthcare.

On the basis of type of wound, the wound care market is segmented into chronic wound and acute wound.


Diabetic Foot Ulcer Background and Statistics


Diabetes mellitus, a metabolic disorder characterized by elevated blood glucose, is a serious and growing problem. More than 23 million people in the United States are believed to have diabetes. It is estimated that by 2025, 300 million people worldwide will have diabetes and by 2030, the number will climb to 360 million people. Thus, by 2030, world-wide prevalence will approach 5 percent1. In Medicare Parts A and B fee-for-service beneficiaries with diabetes, the incidence of diabetic foot ulcer is about 6.0% and lower extremity amputation about 0.5%.

Among Medicare Parts A and B fee-for-service beneficiaries with diabetes and foot ulcer, the prevalence of microvascular and macrovascular complications is about 46% and 65%, respectively. Further, among those with a lower extremity amputation, the prevalence of microvascular and macrovascular complications is about 46% and 76%, respectively.

In general, the incidence of nontraumatic lower extremity amputations (LEAs) has been reported to be at least 15 times greater in those with diabetes than with any other concomitant medical illness. It has been reported that annually about 1 to 4 percent of those with diabetes develop a foot ulcer; 10 to 15 percent of those with diabetes will also have at least one foot ulcer during their lifetime1. This translates to around 2-3 million people in US suffering from foot ulcer yearly.

LEA is less common but is an extreme complication associated with diabetes and foot ulcer. In the U.S., nearly 80,000 LEAs are performed on diabetics each year. In 2005, the overall rate of hospital discharge for new LEA was about 4.3 per 1,000 people with diabetes compared with a rate of about 0.3 per 1,000 in the general population1.

Thus, there is a grave need for a better and more effective treatment for diabetic foot ulcer. Proper treatment of foot ulcer will prevent potential amputation, which will lead to major cost savings and an increase in the quality of life for the patients.


1Incidence of diabetic foot ulcer and lower extremity amputation among Medicare beneficiaries, 2006 to 2008 (David J. Margolis, et al)