Pherecydes Pharma Receives a Favorable Opinion From the Ethics Committee to Initiate the PhagoDAIR Study
- PhagoDAIR is a phase I/II clinical study for the treatment of osteoarticular infections of prostheses due to Staphylococcus aureus
- This Ethics Committee approval will allow patient enrollment to begin during the spring of 2022 as anticipated
- The first results of the study are expected in the summer of 2023
NANTES, France--(BUSINESS WIRE)--Regulatory News:
Pherecydes Pharma (Paris:ALPHE) (FR0011651694 - ALPHE), a biotechnology company specializing in precision phage therapy to treat resistant and/or complicated bacterial infections, today announces that it has been given the go-ahead by the Ethics Committee (Comité de Protection des Personnes, Ile de France III) for the PhagoDAIR program, a phase I/II clinical study for the treatment of osteoarticular infections of prostheses due to Staphylococcus aureus.
PhagoDAIR is the world’s first study of phage therapy to be carried out in this indication. Its protocol was approved by the ANSM (French National Agency for the Safety of Medicines) in December.
It will be undertaken in France and Spain on 60 patients with a knee or hip joint infection due to S.-aureus, divided into one group who will be treated with phage therapy and another group who will receive a placebo, in addition to the standard of care. The patients treated with phase therapy will receive anti-Staphylococcus aureus phages that are active on their strain, selected thanks to Pherecydes Pharma’s phagogram. The standard of care will comprise 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 patients will continue to be monitored for 2 years.
The favorable opinion from the Ethics Committee paves the way for the start of the enrollment of the study in French medical centers this spring. The results are expected during the summer of 2023 and patient monitoring will continue through to the first half of 2025. Depending on the preliminary results of the phase I/II study, Pherecydes Pharma intends to carry out a phase III study in the same indication that could begin in late 2023 or early 2024.
Guy-Charles Fanneau de La Horie, Chairman of the Executive Board of Pherecydes Pharma, said: “Following the ANSM’s approval of the protocol of the PhagoDAIR clinical study at the end of December, this go-ahead from the Ethics Committee completes our regulatory path, allowing us to launch the first clinical study with our phages in the treatment of osteoarticular infections on joint prostheses due to Staphylococcus aureus. PhagoDAIR being the world’s first study of this type, it represents a real hope for the many patients facing a therapeutic impasse due to the lack of effective treatments within the context of rising antibiotic resistance. We are already in contact with the participating clinical centers so that the first patients can be enrolled this coming spring”.
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
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