TechnoPhage is proud to announce that the Phase I/IIa Clinical Trial of TP-102, a novel bacteriophage cocktail developed for the treatment of infected diabetic foot ulcers, has been successfully completed.
This Clinical Trial was designed to evaluate the safety and tolerability of the drug in subjects with infections caused by Pseudomonas aeruginosa, Staphylococcus aureus and Acinetobacter baumannii, which contribute to increased morbidity and mortality of diabetic patients, and whose resolution is often not found in current therapeutic approaches.
Overall, the safety data obtained in this study showed that the biologic was well tolerated by patients, exhibiting a favorable safety profile, with no adverse effects related to the application of the product. The efficacy data obtained is very promising and encourages the rapid development of subsequent clinical phases.
TP-102 was also applied under “compassionate use” by Dr. Michal Dekel, a physician responsible for phage therapy treatments in Tel Aviv, Israel. Regarding the successful results of the compassionate administration of bacteriophages in infected diabetic foot ulcers, Dr. Michal Dekel says that “these patients have improved dramatically” and that “are well and being followed up as outpatients”.
The Portuguese biopharmaceutical company is now preparing the next clinical phase of the product, which was granted Fast Track Designation by the U.S. FDA in 2021. The next clinical phases are intended to evaluate the efficacy and safety of TP-102 in a larger number of patients in an international multicenter trial that will begin during 2023.
“We are very excited about our results and the clinical phases ahead,” says Miguel Garcia, CEO of TechnoPhage. “We will continue to prove that this biological medicine is safe, effective and a valid treatment option for many patients who currently have no alternatives,” says the CEO.