Pherecydes Pharma: receives the positive opinion of the Committee for the Protection of Persons to initiate the PhagoDAIR study








Pherecydes Pharma receives the positive opinion of the Committee for the Protection of

People to initiate the PhagoDAIR study

  • PhagoDAIR is a phase I/II clinical study in the treatment of bone and joint infections on prostheses caused by Staphylococcus aureus
  • The agreement of the CPP allows to start as anticipated the recruitment of patients in the spring of 2022
  • The first results of the study are expected in the summer of 2023

Nantes, February 7, 2022, 5:45 p.m. CET Pherecydes Pharma (FR0011651694 – ALPHE), a biotechnology company specializing in precision phage therapy intended to treat bacterial infections resistant to antibiotics and/or complicated, announces today that it has received the positive opinion of the Committee for the Protection of Persons (CPP) Ile de France III for the PhagoDAIR study, a phase I/II clinical study in the treatment of bone and joint infections on prostheses caused by Staphylococcus aureus (Staphylococcus aureus).

PhagoDAIR is the first phage therapy study in the world conducted in this indication. Its protocol was approved by the National Agency for the Safety of Medicines and Health Products (ANSM) last December.

It will be conducted in France and Spain on 60 patients suffering from an infection of the knee or hip joint due to S.-aureus, distributed between the phage therapy treatment group and the control group which will receive placebo, in addition to the reference treatment. Patients treated with phage therapy will receive anti-phageStaphylococcusaureus active on their strain, selected using the Pherecydes Pharma phagogram. The reference treatment will consist of the surgical procedure called DAIR (Debridement, Antibiotics, Implant Retention1) associated with suppressive antibiotic therapy. The evaluation will be done 12 weeks after the application of the phages and the follow-up of the patients will last 2 years.

The positive opinion of the CPP paves the way for the start of the recruitment of the study in the French centers from the spring of 2022. The results are expected in the summer of 2023 and the follow-up will continue until the course of the 1er half of 2025. Depending on the preliminary results of phase I/II, Pherecydes Pharma will conduct a phase III study on the same indication which could start at the end of 2023, beginning of 2024.

Guy-Charles Fanneau de La Horie, Chairman of the Management Board of Pherecydes Pharmasays: “After ANSM’s approval of the PhagoDAIR study protocol at the end of December, this positive opinion from the CPP completes our regulatory procedures in order to be able to start the first clinical study with our phages in the treatment of osteoarticular infections on prostheses due to Staphylococcus aureus. PhagoDAIR being the first study of its kind in the world, it represents real hope for many patients who find themselves in a therapeutic impasse, due to a lack of effective treatments in the context of growing antibiotic resistance. We are already in contact with the participating clinical centers in order to be able to start the first patient inclusions this spring. »

1 Debridement, Antibiotics and Prosthesis Maintenance

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 viruses that kill bacteria. Pherecydes Pharma 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. The concept of precision phage therapy has been successfully applied to dozens of patients in the context of compassionate treatment, under the supervision of the National Agency for the Safety of Medicines (ANSM). Pherecydes Pharma, whose head office is in Nantes, relies on a team of around twenty experts from the pharmaceutical industry, biotechnologies and academic research.

For more information, www.pherecydes-pharma.com

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Warning

This release contains non-factual materials, including, but not limited to, certain statements regarding future results and other future events. These statements are based on the current view and assumptions of the Company’s management. They incorporate known and unknown risks and uncertainties that could cause actual results, profitability and expected events to differ materially. Further, Pherecydes Pharma, its shareholders and its respective affiliates, directors, officers, counsel and employees have not verified the accuracy of, and make no representations or warranties about, any statistical information or forward-looking information contained herein. release that are or are derived from third party sources or industry publications. These statistical data and forward-looking information are used in this press release for informational purposes only.

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Disclaimer

Pherecydes Pharma SA published this content on February 07, 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 February 2022 16:49:01 UTC.

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