Technophage, a biopharmaceutical company specializing in the development and production of biologics, particularly bacteriophage-based products, has officially announced the successful dosing of the first patient in this pivotal stage. The trial aims to assess the efficacy of TP-102 in treating diabetic foot ulcers infected by Staphylococcus aureus, Pseudomonas aeruginosa, and Acinetobacter baumannii (ID NCT05948592).

This Phase 2b trial is a double-blinded, randomized, placebo-controlled, multicentre study designed to evaluate both the safety and efficacy of TP-102 in patients with Diabetic Foot Infections. Patients will receive a topical application of the investigational product or placebo solution directly on the target ulcer. To be eligible for inclusion, patients must have an infected DFU with at least one target bacterial strain susceptible to TP-102, identified through a culture taken from the target ulcer during the screening visit. The study aims to enroll  80 patients meeting these criteria.

Sofia Côrte-Real, CSO and Deputy CEO of Technophage, expressed satisfaction with the initiation of TP-102 administration, stating, “We are very pleased to effectively start with the administration of TP-102 to patients in need.” She further highlighted the company’s commitment to delivering innovative medicines to address unmet needs in patient care. Miguel Garcia, the founder and CEO of Technophage, echoed this feeling, emphasizing their anticipation for continued patient enrollment and dosing throughout the trial.

The first patient in this innovative trial was randomized in India. The study is currently in progress in both the United States and India, conducted with approval from the Food and Drug Administration and authorization from the Central Drugs Standard Control Organization, respectively.