FDA Greenlights Phase 3 Trial for Diabetic Foot Ulcer Treatment by Discovery Therapeutics Caribe

Discovery Therapeutics Caribe (DTC), a clinical-stage biotechnology firm, has recently made significant strides in its clinical program aimed at developing regenerative therapies for severe diseases. In the first quarter of 2024, the company submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). This application includes a phase 3 protocol for a randomized, double-blind, placebo-controlled trial of their leading product, an intralesional recombinant human Epidermal Growth Factor (rhEGF), intended to treat complex and refractory diabetic foot ulcers (DFU).

The severity of these DFUs is equatable to advanced stages in several classification systems, highlighting the increased risk of amputation and mortality associated with the condition. On April 10, 2024, the FDA approved the IND, allowing DTC to proceed with their pivotal Phase 3 clinical investigation. This trial marks the first time intralesional rhEGF will be tested in U.S. patients with DFU, despite its global availability as Heberprot-P® in 26 countries. The management at DTC is optimistic about commencing this trial by the end of 2024, building upon extensive data from international studies.

Dr. David Armstrong, a leading podiatric surgeon and an authority on diabetic foot ulcers at the University of Southern California, underscored the necessity for innovative treatment options. He pointed out the critical need for therapies that can prevent the progression of DFUs to the point of requiring amputation. Dr. Armstrong has observed the effective use of intralesional rhEGF abroad and anticipates that the upcoming U.S. trial will rigorously assess its efficacy for DFU patients, potentially offering new hope for those in dire need.

Lee Weingart, Co-Founder and President of DTC, expressed satisfaction in initiating the next phase of intralesional rhEGF's global journey in the United States. He highlighted that the Phase 3 clinical trial will enable them to better understand the biologic's clinical profile within the FDA's regulatory framework, leveraging the extensive clinical experience gained internationally.

Dr. Charles Zelen, President of the Professional Education & Research Institute (PERI), emphasized the importance of preventing severe outcomes associated with DFUs to save lives and limbs in America. He highlighted the alarming mortality rate among patients who undergo DFU-related amputations and pointed out the disproportionate impact on African American communities. He stressed the need for innovative therapeutic options for severe DFUs, noting that PERI is dedicated to making these critical clinical trials a reality to evaluate new biologics like intralesional rhEGF effectively.

Intralesional rhEGF operates by activating the Epidermal Growth Factor (EGF) receptor, stimulating cell growth, migration, and differentiation—essential processes in wound healing. The recombinant version of hEGF, developed using genetically engineered yeast, is designed to penetrate deeper into chronic wounds, enhancing the effectiveness of treatments compared to growth factors applied topically.

Heberprot-P® has been authorized for marketing in 26 countries for DFUs and has been administered to over 426,000 patients worldwide since its initial approval in Cuba in 2006. This medication is a crucial option for patients dealing with this severe condition globally.

DFUs are a serious complication of diabetes that leads to high morbidity rates, increased hospitalizations, lower limb amputations, and even death. It is estimated that up to 34% of people with diabetes will develop a DFU in their lifetime, highlighting the critical need for effective treatment options such as those being developed by DTC.