Pherecydes Pharma : announces the enrollment of the first patient in the phase II study PhagoDAIR in the treatment of osteoarticular infections caused by Staphylococcus aureus

Pherecydes Pharma announces the enrollment of the first patient in the phase II study PhagoDAIR in the treatment of osteoarticular infections caused by Staphylococcus aureus

Nantes, June 15, 2022 - 6:00 pm CEST - Pherecydes Pharma (FR0011651694 - ALPHE), a biotech company specializing in precision phage therapy for the treatment of resistant and/or complicated bacterial infections, announced today the enrollment of the 1st patient in the PhagoDAIR Phase II clinical trial.

PhagoDAIR is the world's first study of phage therapy conducted in osteoarticular infections on prostheses caused by Staphylococcus aureus (S. aureus). Its protocol was approved by the ANSM (French National Agency for the Safety of Medicines) last December and by the Ethics Committee (Comité de Protection des Personnes) in February 2022.

Pherecydes Pharma is now actively recruiting patients for this clinical trial, the first of which has just been enrolled in France, at the Hospices Civils de Lyon (HCL).

The study, which will also be conducted in other European countries, plans to include 64 patients with S. aureus infection of the knee or hip joint, divided between the phage therapy group and the control group, which will receive placebo in addition to the standard of care. Patients treated with phage therapy will receive the anti-Saureus phages active on their strain, selected thanks to Pherecydes Pharma's phagogram. The standard of care will consist of the surgical procedure called DAIR (Debridement, Antibiotics, Implant Retention) combined with a suppressive antibiotic therapy. The assessment will be carried out 12 weeks after the phages are applied and the follow-up of the patients will last 2 years.

The first results are expected at the end of 2023 and the follow-up of patients will continue until the 1st half of 2025. Based on the preliminary results of the Phase II trial, Pherecydes Pharma will conduct a Phase III trial in the same indication which could start in 2024.

Didier Hoch, Chairman and CEO of Pherecydes Pharma, said: "I would like to thank the clinical teams at HCL for their exemplary involvement, which has allowed us to start this clinical study according to plan. This clinical study is the first step of an ambitious clinical development plan with phages developed by Pherecydes."

Pascal Birman, Medical Director of Pherecydes Pharma, commented: "As the first phage therapy clinical trial in the world in this indication, PhagoDAIR represents a real hope for many patients in therapeutic deadlock. Thanks to the efforts of all its staff and partners, Pherecydes Pharma is at the forefront of the fight against antibiotic resistance, and we hope that the first results of the study will lead to an effective therapeutic solution to this major public health issue."

Professor Tristan Ferry, Coordinator of the study and Deputy Head of the Infectious and Tropical

Diseases Department at HCL, concluded: "We are delighted to participate in this major clinical study in a very difficult to treat indication. Phage therapy is a treatment strategy that has been known for many years, and we have been seeking to develop it at the Croix-Rousse Hospital since 2017, with experience gained in the field of complex osteoarticular infections at CRIOAc Lyon (HCL). Thanks to Pherecydes Pharma, for the first time we have phages whose quality meets the strictest pharmaceutical standards. If successful, this study could represent a true paradigm shift in the management of complicated bacterial infections."

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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 to more than 50 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

Contacts

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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.

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