Pherecydes Pharma Announces a First Registration of Its Phagogram as an in Vitro Diagnostic Test in Accordance With EC Directives
This vital tool for precision medicine thus meets regulatory requirements and clinicians’ expectations
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, today announces the registration of its phagogram as an in vitro diagnostic test (“Phagogram 1.5”) in accordance with Directive 98/79/EC.
The phagogram is an in vitro diagnostic test to verify the sensitivity of patients’ bacterial strains to Pherecydes Pharma’s phages. Hence only active phages are administered, increasing phage therapy’s chances of success. Pherecydes Pharma is developing its phagogram for three target bacteria: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. These bacteria, which are the most resistant and dangerous according to the World Health Organization (WHO), alone account for more than two thirds of hospital-acquired resistant infections in industrialized countries1.
The EC registration of the Phagogram 1.5 was made possible by the setting up of a new specialized laboratory in Nantes; this new laboratory initially ensured the development and validation of the in vitro diagnostic test following a very stringent process from a technical, quality and regulatory perspective. It is now responsible for carrying out phagograms for patients enrolled in our clinical studies and patients undergoing compassionate treatment.
The Phagogram 1.5 program is the first stage in a broader strategic program whose goal is to develop a new generation phagogram, “Phagogram 2.0”, in collaboration with the CEA (cf. Pherecydes Pharma press release of January 3, 2022). This program aims to significantly shorten the leadtime required for a diagnosis and thus offer phage therapy in all types of indications, whether acute or chronic.
“I would like to congratulate all the Pherecydes Pharma teams for the efforts they have devoted to this pivotal mission for our Company”, stated Didier Hoch, Chairman and CEO of Pherecydes Pharma. “Indeed, the phagogram is a fully fledged project within Pherecydes Pharma, and this registration represents a milestone on the road to developing the new generation phagogram that will be a differentiating asset in the increasingly dynamic and attractive field of phage therapy.”
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. The concept of precision phage therapy has been successfully applied in several dozen patients in the context of compassionate use, under the supervision of the French National Agency for the Safety of Medicines (ANSM). Headquartered in Nantes, Pherecydes Pharma has a team of around twenty experts from the pharmaceutical industry, biotechnology sector and academic research.
For more information, www.pherecydes-pharma.com
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.
1 Opatowski M - Hospitalisations with infections related to antimicrobial-resistant bacteria from the French nationwide hospital discharge database, 2016
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