Technophage announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TP-102, the company’s first bacteriophage cocktail, for the treatment of infected diabetic foot ulcers caused by three different bacteria (Pseudomonas aeruginosa, Staphylococcus aureus and/or Acinetobacter baumannii).
“The Fast Track designation now granted by the FDA will expedite the development of TP-102 and we hope to work closely with the Agency moving forward with this biologic therapy,” said Miguel Garcia, CEO of Technophage. “While other antimicrobial treatments for this clinical indication are not able to reach the affected tissue in an adequate dose, bacteriophages are able to replicate upon the detection of its host, eliminating the bacterial infection locally”, complemented the CEO.
Diabetic foot infections constitute a significant medical problem and the incidence of these wounds will probably increase as the population ages. Many diabetic patients will develop ulcers that get infected throughout their lifetime, and among those, approximately 28% will eventually require an amputation without an adequate treatment, thus contributing to the decrease of their life expectancy.
Technophage is currently conducting a Phase I/IIa clinical trial (NCT04803708) to evaluate the safety and tolerability of TP-102 as a potential topical treatment for foot infections caused by critical pathogens in diabetic patients (REVERSE study). The results of the study are expected during 2021.