PHAXIAM Therapeutics announces a high level of performance of its two anti-
Staphylococcus aureus
on clinical strains
Data obtained from the phagogram developed by PHAXIAM, the first phage sensitivity test with CE marking, showed a response rate of 98% on 105 clinical strains of
S. aureus
Lyon (France) and Cambridge (MA, US), October 9, 2023 – 10:05 p.m. CEST – PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM),
announces a very broad spectrum of activity of its anti-S phages. aureus (PP1493 and PP1815) against clinical bacterial strains.
A retrospective analysis was carried out on 105 clinical strains of
Staphylococcus aureus,
tested using the PHAXIAM phagogram in clinical trials, life-saving therapies and Compassionate Access Authorizations (CAAs). The results demonstrated that 98% of these pathogenic strains of
S. aureus
were sensitive to at least one of the two anti-phages
S. aureus
of PHAXIAM (PP1493 and PP1815).
The phagogram is a diagnostic test
in vitro
(IVD) designed to measure the sensitivity of bacterial strains present in patients to PHAXIAM Therapeutics phages. It is also the first IVD test dedicated to the evaluation of phage activity which has CE marking.
Thibaut du Fayet, Managing Director of PHAXIAM Therapeutics,
states:
“The data obtained from this retrospective analysis confirm that our phagogram is a very effective IVD platform for our current and future clinical developments. The activity spectrum of 98% of our anti-S phages. aureus is exceptionally high compared to other competing solutions. The data obtained also prove that our phagogram is very efficient, making it a unique asset for the development of other phages in our portfolio. I would like to thank all our teams for the remarkable work they have accomplished on this project over several years. Such a differentiating asset, combined with our unique clinical activity data obtained during our compassionate and AAC treatments, confirms that PHAXIAM is well positioned to become a world leader in phage therapy and intensify the fight against severe and resistant infections. »
About phagogram development
The phagogram is a diagnostic test
in vitro
(IVD) designed to determine the sensitivity of bacterial strains present in patients to PHAXIAM Therapeutics phages. This solution meets the safety and performance requirements of antibiotic susceptibility testing. PHAXIAM developed and validated this phage sensitivity test in accordance with European Directive 98/97/EC. The reliability (repeatability and reproducibility) and accuracy criteria presented by the phagogram have been shown to comply with international analytical standards such as ISO 20776-2 and FDA analytical guidelines. PHAXIAM has developed a diagnostic laboratory
in vitro
fully equipped dedicated to the evaluation of experimental therapeutic phages. The PHAXIAM diagnostic laboratory was designed and implemented in accordance with ISO 15189 (Biological Medical Laboratory) and ISO 13485 (Medical Device).
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
Contacts
|
PHAXIAM Eric Soyer COO & CFO Chief Operating Officer +33 4 78 74 44 38 [email protected] |
NewCap Mathilde Bohin / Dušan Orešanský Investor relations Arthur Rouille Media relations +33 1 44 71 94 94 [email protected] |
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.
Attachment
CP_PHAXIAM_Phagogram_FR_09.10.2023