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 that it has obtained ANSM (French National Agency for the Safety of Medicines) approval to carry out a phase I/II clinical study – PhagoDAIR – in the treatment of osteoarticular infections of prosthetic joints caused by Staphylococcus aureus.
The World Health Organization (WHO) considers Staphylococcus aureus (S.-aureus) to be a high priority pathogenic agent in terms of the research and development of new treatments1, given that over 25% of S. aureus strains are antibiotic-resistant. In osteoarticular infections of prosthetic joints, the indication targeted by the PhagoDAIR study, 30% to 50% of cases are due to resistant S.-aureus2.
PhagoDAIR is the world’s first study of phage therapy to be carried out in this indication. 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 phage 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 study’s objectives will be to assess the efficacy and tolerance of phages combined with DAIR, a surgical procedure during which the phages are applied. This assessment will be undertaken 12 weeks after the DAIR surgical procedure, and patients will continue to be monitored for 2 years.
Pherecydes Pharma is planning to initiate patient enrollment in the spring of 2022, once it receives the approval of the CPP Patient Protection Committee, which will meet in January 2022. The results are expected in the summer of 2023 and 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 at the end of 2023.
Guy-Charles Fanneau de La Horie, Chairman of the Executive Board of Pherecydes Pharma, commented: “The ANSM’s approval of the protocol of the PhagoDAIR clinical study is excellent news for our Company, but also for the many patients suffering from osteoarticular infections on their joint prostheses due to Staphylococcus aureus. Indeed, this is the first study in this indication using phage therapy, and we are eager to assess our winning phages, specifically selected for their activity on this particularly hard-to-treat bacterium. This study is one of the pillars of our development strategy presented at the time of our IPO, in early 2021, and its upcoming launch brings us even closer to our goal of becoming a world leader in 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.
2 Wouthuyzen-Bakker et al (2019)