PHAXIAM Therapeutics announces the recruitment of the first patient in the phase 1 study in infective endocarditis caused by Staphylococcus aureus – 04/15/2024 at 07:30

• The study plans the inclusion of 12 patients in 5 French clinical centers
  

• The first results are expected on 3
  
  
  

  th
  
  
  

  quarter 2024
  

• This study makes it possible to evaluate the intravenous administration of phages, particularly suitable for addressing indications with very high medical issues.
  

Lyon (France) and Cambridge (MA, US), April 15, 2024 – 7:30 a.m. CEST – PHAXIAM Therapeutics (Nasdaq & Euronext: FR0011471135),

today announces the inclusion of 1

^er

patient in phase 1 clinical trial in infective endocarditis caused by

Staphylococcus aureus (S. aureus)

.

Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria. This can lead to heart failure, heart valve damage and stroke. It remains one of the deadliest heart diseases, with a death rate of 30 to 40%. Main cause of infective endocarditis,

S. aureus,

is responsible for around 30%

¹

cases. Its treatment involves taking antibiotics, sometimes combined with surgery to repair damage to the heart valves. Considering the increasing 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, in order to control and reduce the mortality rate of infectious endocarditis

The protocol for the multicenter phase 1 study of PHAXIAM in this indication has received the necessary approvals from the ANSM and the CPP Sud-Est II-Lyon. The study provides for the inclusion of 12 patients requiring replacement of the infected heart valve, in 5 French hospital centers (Henri Mondor Hospital in Créteil, Bichat-Claude Bernard Hospital in Paris, Nantes University Hospital and Nancy University Hospital, La Pitié- Salpêtrière in Paris).

The first patient was recruited at the Henri Mondor hospital by the teams of Professor Pascal Lim, principal investigator of the study. Patients will be treated for 2 to 4 days with the combination of 2 anti-

S. aureus

, administered intravenously 1 or 2 times a day, until the day of surgery. The primary objective of the study is to verify the safety of administering PHAXIAM phages intravenously, to study their pharmacokinetics in the blood and to measure their concentration in the valve resected during surgery.

These data, very important for PHAXIAM and more broadly for the development of phage therapy, will make it possible to define the optimal administration schedule by intravenous injection and will also be used for future studies of the effectiveness of phage therapy in indications using this route of administration. . The first results of the study are expected on 3

^th

quarter 2024.

Pr. Pascal Lim, Head of Cardiac Intensive Care at Henri Mondor Hospital and principal investigator of the study,

comments:

“The treatment of infective endocarditis linked to

S. aureus

presents many challenges and we are delighted to participate in this study which will evaluate for the first time phage therapy in this pathology whose mortality remains high. We thus hope to contribute to improving the care of patients who often find themselves in a therapeutic impasse. »

Thibaut du Fayet, Managing Director of PHAXIAM

concludes:

“The inclusion of the first patient in the phase 1 study in infective endocarditis is a major step in our development strategy, which aims to put phage therapy at the service of patients suffering from pathologies with high medical need. The preliminary results of this study, planned for Q3 2024, will make it possible to analyze the tolerance and the first signals of effectiveness of the intravenous administration method of our anti-phage phages.

S. aureus

in an indication where the reduction of mortality, still reaching 30 to 40%, constitutes an essential issue. We look forward to obtaining these data, which, if successful, will give us a decisive competitive advantage and pave the way for the use of this method of administration for our phages in other high-need indications. unaddressed medical conditions, such as bacteremia. »

About PHAXIAM Therapeutics

PHAXIAM is a biopharmaceutical company that develops innovative treatments against resistant bacterial infections, responsible for many serious infections. The company relies on an innovative approach based on the use of phages, natural bacteria-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which alone represent more than two thirds of resistant nosocomial infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.

PHAXIAM is listed on the regulated market of Euronext in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indices.

For more information, please visit: www.phaxiam.com

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Forecast information

This press release contains forward-looking statements, forecasts and estimates regarding the clinical programs, development plans, business and regulatory strategy and anticipated future performance of PHAXIAM and the market in which it operates. Some of these statements, forecasts and estimates may be identified by the use of words such as, without limitation, “believe”, “anticipate”, “expect”, “intend”, “plan”, “seek to”, “estimate”, “may”, “continue” and other similar expressions. All statements contained in this press release other than statements of historical fact are forward-looking statements. These statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were believed to be reasonable at the time they were made but which may or may not prove to be accurate. Actual events are difficult to predict and may depend on factors beyond PHAXIAM’s control. Therefore, actual results may differ materially from anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates. The reader is invited to carefully read the risk factors appearing in the regulatory documents filed by the Company with the Financial Markets Authority (AMF), including in the 2023 Universal Registration Document of the Company filed with the AMF on April 5, 2024, as well as in future documents and reports filed by the Company. Given these uncertainties, no representation is made as to the accuracy or fairness of these forward-looking statements, forecasts and estimates. Further, forward-looking statements, forecasts and estimates speak only as of the date of this press release. PHAXIAM undertakes no obligation to update any such forward-looking statements, forecasts or estimates to reflect any change in PHAXIAM’s expectations with respect thereto, or any change in events, conditions or circumstances on which such statements, forecasts or estimates are based, except to the extent required by law.

1

Selton-Suty C., Célard M., Le Moing V., et al. Preeminence of Staphylococcus aureus in infectious endocarditis: a 1-year population-based survey. Clin Infect Dis 2012; 54:1230-9.

Attachment

• CP_PHAXIAM_15042024_FPI-Endocarditis_FR