Phaxiam Therapeutics has announced the enrolment of the first patient to a Phase I trial on the treatment of endocarditis infections caused by the bacteria Straphylococcus aureus (S. aureus).
Endocarditis, the inflammation of the inner lining of the heart’s chambers and valves, is usually caused by bacteria and can result in heart failure, valve damage and stroke.
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Research indicates that the infection, which holds a 30% to 40% death rate, is caused by Staph aureus in around 30% of cases.
Having received relevant approvals on the design of its study from France’s regulatory agency the Agence nationale de sécurité du médicament et des produits de santé (ANSM) and Sud-Est II-Lyon Ethics committee, Phaxiam enrolled its first patient from the Henri Mondor Hospital in Créteil, France.
The French company, which develops antibacterial treatments based on the use of bacteriophage viruses (phages), ultimately plans to enrol a total of 12 patients requiring replacement of an infected heart valve into the study.
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Enrolled patients will be treated between two and four days with a combination of two anti-Staph aureus phages administered intravenously once or twice daily until the day of surgery.
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By GlobalDataPatients will be recruited across five French clinical centres including Henry Mondor and Bichat-Claude Bernard hospital in Paris.
Pascal Birman, chief medical officer of Phaxiam told Clinical Trials Arena of two expectations for the trial: “To confirm the safety of IV administration of phages, and to identify the most appropriate schedule of IV administration (once or twice-a-day IV administration) by assessing the concentrations of phages in the blood and in the infected valve.”
Phaxiam said that given the increase in the incidence and mortality of endocarditis due to Staph aureus in the context of growing antibiotic resistance, the development of new therapies has become a necessity to control and reduce the mortality rate of infectious endocarditis.
Phaxiam CEO Thibaut du Fayet said: “The inclusion of the first patient in the Phase I study in endocarditis infection is a key step in our development strategy, which aims to provide phage therapy to patients suffering from diseases of high medical needs.
“The first results of this study, expected in Q3 2024, will enable us to analyse the safety and first efficacy signals of our anti-Staph aureus phages with intravenous administration, in an indication where reducing mortality, which is still between 30% and 40%, is a major medical challenge.”
He concluded: “We look forward to these data, which, if positive, will give us a significant competitive advantage and will pave the way for the use of this administration route for our phages in other indications with significant unmet medical needs, such as bacteraemia.”
The European Society of Cardiology (ESC) recently called for patients with specific cardiac conditions to be vigilant about cardiac infections and practice good dental and skin hygiene to help prevent rare but potentially deadly infections of the heart’s inner lining and valves.
Research from 2019 by Lawson Health Research Institute discovered a link between those in Ontario, Canada who inject themselves with opioid hydromorphone and an increase in bacterial heart infections.
