Press release written by Daniela Jones Dias, PhD Head of preclinical development at TechnoPhage.
TechnoPhage announces FDA Fast Track Designation granted to TP-102 for the treatment of patients with infected diabetic foot ulcers
TP-102 is currently being evaluated in an ongoing Phase I/IIa clinical trial.
TechnoPhage, a Portuguese clinical-stage biopharmaceutical company, 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 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.
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.