Pherecydes Pharma presented at the ECCMID congress an analytical performance protocol demonstrating the compliance of its Phagogram 1.5 with regulatory requirements
NANTES, France--(BUSINESS WIRE)--Regulatory News:
Pherecydes Pharma (FR0011651694 - ALPHE) (Paris:ALPHE), a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections (the “Company”), presented part of its analytical performance plan adapted to its Phagogram 1.5 on April 15, 2023, at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) in Copenhagen (Denmark).
The phagogram is an in vitro diagnostic test designed to check the sensitivity of patients' bacterial strains to Pherecydes Pharma phages. In vitro diagnostic devices must meet the required safety and performance levels based on an analytical performance protocol. However, such a protocol does not exist for phages due to the lack of clearly defined development principles.
Pherecydes Pharma developed and validated an analytical performance plan applicable to phages and compliant with the European directive 98/97/EC. The components of Phagogram 1.5 were tested using anti-Staphylococcus aureus phages and the performance plan was shown to be fully applicable in this configuration. It was also demonstrated that the reliability (repeatability and reproducibility) and accuracy criteria presented by Phagogram 1.5 are in line with some international analytical standards, such as ISO 20776-2 and the FDA analytical guidelines.
Dr. Rafael Gomes Von Borowski, Diagnostic & Development Manager of Pherecydes Pharma, stated: "We are proud to present to the healthcare industry the latest regulatory and technical developments of our phagogram, a tool dedicated to phage therapy. It meets both regulatory requirements and clinicians' expectations, which we demonstrated through the analytical performance plan designed by our teams. Our final goal remains the development of a new generation phagogram, which will enable us to use phage therapy in all types of indications, whether acute or chronic, thanks to a significant reduction in the time required to make a diagnosis”.
Title of the presentation: Antimicrobial Susceptibility Testing (AST) for phages In Vitro selection and follow-up (according to CE-IVD)
About Pherecydes Pharma
Founded in 2006, Pherecydes Pharma is a biotechnology company that develops treatments against resistant bacterial infections, responsible for many serious infections. The Company has developed an innovative approach, precision phage therapy, based on the use of phages, natural bacteria-killing viruses. Pherecydes Pharma is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which alone account for more than two thirds of hospital-acquired resistant infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. Headquartered in Nantes, Pherecydes Pharma has a team of around twenty experts from the pharmaceutical industry, biotechnology sector and academic research. Pherecydes Pharma announced on February 15, 2023 its plan to merge with Erytech, which will be subject to the approval of the respective shareholders of both companies.
For more information, www.pherecydes-pharma.com
Disclaimer
This press release contains non-factual elements, including, but not limited to, certain statements regarding future results and other future events. These statements are based on the current vision and assumptions of the management of the Company. They incorporate known and unknown risks and uncertainties that could result in significant differences in results, profitability and expected events. In addition, Pherecydes Pharma, its shareholders and its affiliates, directors, officers, counsels and employees have not verified the accuracy of, and make no representations or warranties about, statistical information or forecast information contained within this news release and that originates or is derived from third party sources or industry publications; these statistical data and forecast information are only used in this press release for information purposes. Finally, this press release may be drafted in French and in English. In the event of differences between the two texts, the French version will prevail.
Contacts
Pherecydes Pharma
Thibaut du Fayet
CEO
investors@pherecydes-pharma.com
NewCap
Dusan Oresansky / Nicolas Fossiez
Investor Relations
pherecydes@newcap.eu
T.: 01 44 71 94 92
NewCap
Arthur Rouillé
Media Relations
pherecydes@newcap.eu
T.: 01 44 71 00 15
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