PHAXIAM Therapeutics obtains the necessary authorizations to launch its phase 1 study in infective endocarditis caused by Staphylococcus aureus – 10/24/2023 at 10:05 p.m.

• Approval of the study protocol by the ANSM and the Committee for the Protection of People (CPP) Sud-Est II Lyon
  

• Start of recruitment of 12 patients planned for the 4th
  
  
  

  th
  
  
  

  quarter 2023 in 4 French centers
  

• First results of the study expected in mid-2024
  

Lyon (France) and Cambridge (MA, US), October 24, 2023 – 10:05 p.m. CEST – PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM), a biopharmaceutical company developing innovative treatments against resistant bacterial infections,

announces that it has received approval from the National Agency for the Safety of Medicines and Health Products (ANSM) and the Committee for the Protection of People (CPP) Sud-Est II-Lyon of the protocol for its phase 1 study in the 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 antibiotics, sometimes combined with surgery to repair damage to the heart valves. Despite advances in the prevention and treatment of other cardiovascular diseases, the incidence and mortality of endocarditis due to

S. aureus

have increased in recent years, requiring the development of innovative therapies to combat antibiotic resistance.

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. This study plans to include 12 patients requiring replacement of the infected heart valve. Recruited in 4 French hospital centers (Henri Mondor in Créteil, Bichat-Claude Bernard Hospital in Paris, Nantes University Hospital and Nancy University Hospital), patients will be treated for 2 to 4 days with the combination of 2 anti-phages.

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 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 requiring this route of administration. The first results of the study are expected in mid-2024.

Pascal Birman, Medical Director of PHAXIAM Therapeutics

states:

“This phase 1 study was designed with the main objectives of evaluating the tolerance and pharmacokinetics of our anti-S phages. aureus in the treatment of infective endocarditis. It also aims to validate the intravenous route of administration, likely to improve the exposure of patients to our phages. Subject to positive data, we may use this mode of administration in subsequent efficacy studies in larger patient populations and in other clinical indications, associated with a high unmet medical need, such as bacteremia. »

Thibaut du Fayet, Managing Director of PHAXIAM Therapeutics,

concludes:

“These authorizations allow us to take an important step in our S. aureus program, the most strategic, by positioning ourselves on a second indication with high added value. With this new clinical study, we reaffirm our ambition to position phage therapy in indications with high unmet medical needs, for which in particular the reduction of patient mortality is a critical issue. The treatment of infective endocarditis caused by S. aureus using phage therapy could thus provide a major alternative and hope for many patients in therapeutic impasse.

. »

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 Nasdaq Capital Market in the United States (ticker: PHXM) and 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 results and development plans of eryaspase, the commercial and regulatory strategy and the 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, including, without limitation, statements regarding PHAXIAM’s expectations regarding the effects of the transfer of the listing of its ADSs on the Nasdaq Capital Market. 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. Important factors that could cause actual results to differ materially from those indicated in the forward-looking statements include, among others, the following: (1) market reaction to the transfer of listing of PHAXIAM’s ADSs to the Nasdaq Capital Market ; (2) the inability to maintain the listing of PHAXIAM shares on the Nasdaq Capital Market and on the regulated market of Euronext; (3) changes in applicable laws or regulations; (4) the possibility that PHAXIAM may be adversely affected by other economic, business and/or competitive factors; and (5) other risks and uncertainties set forth from time to time in regulatory filings made by PHAXIAM. A more detailed description of these risks, uncertainties and other risks can be found in the regulatory documents filed by the Company with the Autorité des Marchés Financiers (AMF), in the documents and reports filed by the Company with the Securities and Exchange Commission ( SEC), including in the Company’s 2022 Universal Registration Document filed with the AMF on March 28, 2023 and in the Company’s Annual Report on Form 20-F filed with the SEC on March 28, 2023, 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. Readers are cautioned not to place undue reliance on these forward-looking statements. 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_Endocarditis_FR_24-10-2023