Discovery Therapeutics Caribe (DTC), a US company specializing in biotechnology, announced on April 30, 2024 that it has achieved a significant milestone that reflects progress in its clinical development program.
In the first quarter of 2024, DTC submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The filing of this IND included a Phase 3 protocol for a randomized, double-blind, placebo-controlled trial of the company’s lead product: intralesional recombinant human epidermal growth factor (RHEGF) for the treatment of complex ulcers; one of the main complications of diabetes.
The FDA completed its review of the IND and concluded that DTC can proceed with its proposed Phase 3 clinical investigation. On April 10, 2024, DTC received a Study May Proceed (SMP) letter from the FDA. Based on clinical efficacy and safety data collected from international studies. DTC management believes it is on track to initiate this pivotal trial of intralesional RHEGF in the US by the end of 2024. While intralesional RHEGF, marketed globally as Heberprot-P®, is available to patients in more than twenty countries, This is the first time it will be studied in American patients suffering from complex diabetic foot ulcers.
The process of obtaining RHEGF is carried out by the Center for Genetic Engineering and Biotechnology. Heberprot-P, a globally recognized brand of this product, has pharmacovigilance studies in the post-marketing stage for 16 years. It is estimated that more than 400,000 DFU patients have been administered Heberprot-P® worldwide since its initial marketing authorization in the Republic of Cuba in June 2006.
Dr. David Armstrong, a distinguished podiatric surgeon at the University of Southern California and a world-renowned researcher in diabetic foot ulcers, emphasized the critical need for innovative therapies: “There is a pressing need for treatments that can stop the progression of diabetic foot ulcers. diabetic foot ulcers before amputation becomes the inevitable solution Historically, treatment options have been limited, but with the introduction of advanced therapies such as intralesional rhEGF, which I have seen used effectively abroad. “We are hopeful. The upcoming Phase 3 trial in the US will rigorously evaluate its effectiveness for patients with DFU. This trial represents an exciting potential to change the current paradigm and provide new hope to those who desperately need it.”
Lee Weingart, Co-Founder and President of DTC, commented: “We are pleased to begin the next stage of intralesional RHEGF’s global journey here in the United States. The upcoming Phase 3 clinical trial will help us understand the clinical profile of this biologic within the regulatory framework and leverage RHEGF’s extensive international clinical experience.”
In international markets where Heberprot-P® is commercially available, the drug is an important option in the therapeutic arsenal for patients with this serious condition.
Source: BioCubafarma
