TechnoPhage is proud to announce that the first part of the Phase I/IIa Clinical Trial with TP-102 (REVERSE study) has been completed. The study aims to assess the safety and tolerability of this product in individuals with diabetic foot ulcers.
According to the data obtained from the patients included in this first part of the study, which was analyzed by the Safety Committee, there were no adverse effects associated with the study product. The second part of the clinical trial has already started and intends to continue to assess the safety, as well as the efficacy, associated with the product; this second part will now include patients with diabetic foot ulcers infected by three distinct and clinically relevant bacteria.
“The conclusion of the first part of the study allowed us to gather encouraging results.”, said Miguel Garcia, CEO of TechnoPhage. “Our main goal is to complete this trial, establish a robust safety database and proceed to the next phases of development of TP-102.”
The study is being conducted in Israel, under the approval of the Ministry of Health of that country, and is also the first biological medicine, with a Portuguese patent, with approval for entry into a Clinical Trial by the FDA – Food and Drug Administration – of the United States of America.