PHAXIAM Therapeutics announces enrolment of the first patient in the phase 1 study for the treatment of endocarditis infections caused by Staphylococcus aureus

• The study plans for the enrolment of 12 patients in 5 French clinical centers
• First study results expected in Q3 2024
• This study will enable an evaluation of the intravenous administration of phages, particularly adapted to targeting indications with very high medical stakes.
  
  

Lyon (France) and Cambridge (MA, US), April 15, 2024 – 7:30am CEST - PHAXIAM Therapeutics (Nasdaq & Euronext: FR0011471135), today announces the enrolment of the 1^st patient in the phase 1 clinical study in endocarditis infection caused by Staphylococcus aureus (S. aureus).

Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria. It can lead to heart failure, valve damage and stroke. It remains one of the most fatal heart diseases, with a death rate from 30 to 40%. S. aureus, responsible for around 30%¹ of cases, is the main cause of endocarditis infections. Its treatment involves antibiotics, sometimes combined with surgery to repair damage to the heart valves. Given the increase in the incidence and mortality of endocarditis due to S. aureus in the context of growing antibiotic resistance, the development of innovative therapies has become a necessity to control and reduce the mortality rate of infectious endocarditis.

The design of PHAXIAM's multicentric phase 1 study in this indication received the necessary approvals from the French regulatory agency ANSM and Sud-Est II-Lyon Ethics committee. The trial plans to enroll 12 patients requiring replacement of an infected heart valve, recruited across 5 French clinical centers (Henri Mondor in Créteil, Hôpital Bichat-Claude Bernard in Paris, University Hospital of Nantes, University Hospital of Nancy and La Pitié-Salpêtrière in Paris).

The first patient has been enrolled at Henri Mondor Hospital by the team of Professor Pascal Lim, the study's Principal Investigator. Patients will be treated between 2 and 4 days with a combination of two anti-S. aureus phages, intravenously administered once or twice a day, until the day of surgery. The primary objective of the study is to assess the safety of intravenous administration of PHAXIAM’s phages, to study their pharmacokinetics in the blood and to measure their concentration in the valve resected during surgery.