Press release written by Daniela Jones Dias, PhD Senior Scientist at TechnoPhage.
The results of the study are expected during 2021.
TechnoPhage, a clinical-stage biopharmaceutical company developing natural phage treatments that target specific pathogenic bacteria, announced the beginning of Phase I/IIa study (REVERSE) of TP-102, a phage therapy candidate for the treatment of Diabetic Foot Infections (DFI). The first-in-human study is designed to evaluate the safety and tolerability of TP-102 in subjects with both non-infected and infected Diabetic Foot Ulcers (DFU) as the primary endpoint with detection of significant reduction or eradication of target bacteria as secondary endpoints.
This phage cocktail targets strains of Pseudomonas aeruginosa, Staphylococcus aureus, and Acinetobacter baumannii that cause foot infections, and that may contribute to the overall morbidity and mortality of diabetic patients that many times are not able to find a cure in current treatment approaches.
“This product is the first of TechnoPhage’s pipeline to enter clinical trials, constituting an exciting milestone for the company, but also for the phage therapy community” commented Miguel Garcia, CEO of TechnoPhage. “In the end, our main goal is to provide a safe and effective treatment solution for an important unmet medical need”.
The study is being conducted in Israel under an application approved by the Israeli Ministry of Health, and an Investigational New Drug application approved by the U.S. Food and Drug Administration.
Launched in 2005, TechnoPhage is an innovative clinical-stage biopharmaceutical company committed to the R&D of new biological molecules in several therapeutic areas. The company focuses on three different technological platforms and develops full product solutions to answer different clinical needs in the fields of infection, neuroscience, ophthalmology, and more recently, oncology. TechnoPhage is focused on increasing its pipeline of proprietary technologies and deriving products. Additional information is available at www.technophage.pt.