(Boursier.com) — Pherecydes Pharmaa biotechnology company specializing in precision phage therapy intended to treat resistant and/or complicated bacterial infections, announces today that it has submitted an application for authorization of a phase I clinical study in infective endocarditis to the ANSM caused by Staphylococcus aureus (S. aureus).
Endocarditis is an infection of the endocardium (inner layer of the heart) and heart valves most often caused by bacteria. In developed countries, S. aureus is the major cause, accounting for nearly 30% of cases. Patients are systematically hospitalized, their management is very complex and therapeutic alternatives are therefore necessary. Indeed, endocarditis requires heart surgery in 15% to 45% of cases and leads to death in 20% to 30% of hospitalized patients. They cause cardio-neurovascular complications such as stroke, embolization other than stroke, heart failure and intracardiac abscess despite intensive antibiotic therapy.
Endocarditis caused by S. aureus is even more severe than other forms of infection, with a higher risk of death (more than 40%) and greater need for surgery for valve replacement in the acute stage of the disease.
The clinical protocol of the phase I study of Pherecydes Pharma submitted to the ANSM provides for the recruitment of twelve patients in four clinical centers in France. Patients with infective endocarditis caused by S. aureus on a native valve with an indication for valve replacement surgery will receive two anti-S phage variants intravenously. aureus between one and three times a day, for two to four days until surgery.
The primary objective of the study is to measure the concentration of phages in the infected valve in order to identify the optimal scheme of phage administration in this infection. The tolerance and pharmacokinetics of phages in the blood will also be assessed. Subject to the approval of the ANSM and the Committee for the Protection of Persons, the study could be initiated during the 3rd quarter of 2023.
Thibaut du Fayet, CEO of Pherecydes Pharma, declared: “We are very enthusiastic about the idea of evaluating our anti-S. aureus phages in this new indication with very high medical stakes, with the ambition of reducing the rate mortality rate, which is very high today. This new clinical study is part of the strategy of accelerating our clinical plan, reinforced by the proposed merger with Erytech Pharma. It should also allow us to validate a new route of administration (intravenous), critical for our clinical development. The results obtained so far in our preclinical models suggest that the benefit of phage therapy can be significant, particularly in terms of reducing morbidity and mortality; this confirms our well-being based on our clinical strategy based on targeting pathologies with high unmet medical needs.Endocarditis will represent a third clinical indication targeted by anti-S phages. aureus from Pherecydes Pharma, after bone and joint infections on prosthesis and those of diabetic foot ulcer.”
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