The American company Discovery Therapeutics Caribe (DTC), specialized in biotechnology, received authorization from the United States Food and Drug Administration (FDA) to carry out Phase III clinical trials with the Cuban drug Heberprot-P , Biocubafarma reported from its Facebook profile.
This is 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.
DTC management believes it is on track to initiate this pivotal trial of intralesional rhEGF in the United States by the end of 2024, the note noted.
Intralesional rhEGF, marketed globally as Heberprot-P, is available to patients in more than twenty countries, but will be the first time it will be studied in US patients suffering from complex diabetic foot ulcers.
The process of obtaining rhEGF is carried out by the Center for Genetic Engineering and Biotechnology (CIGB) and Heberprot-P is already a recognized brand of this product worldwide, with pharmacovigilance studies in the post-marketing stage for 16 years.
It is estimated that more than 400,000 patients with diabetic foot ulcers have been administered the Cuban drug worldwide since its initial marketing authorization in Cuba in June 2006.
Historically, treatment options for the condition have been limited, but the introduction of advanced therapies such as intralesional rhEGF represents the potential to change the current paradigm and provide new hope to those who need it.
Lee Weingart, co-founder and president of DTC, commented that the upcoming Phase 3 clinical trial will help them understand the clinical profile of this biologic within the FDA 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.
