- Approval of study design by French ANSM and Ethics Committee
- Recruitment of 12 patients expected to start in Q4 2023 in 4 French centers
- First study results expected in mid-2024
LYON, France and CAMBRIDGE, MA, USA I October 24, 2023 I PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM), a biopharmaceutical company developing innovative treatments for resistant bacterial infections, announces the approval of its phase 1 study clinical design in endocarditis infections caused by Staphylococcus aureus (S. aureus) by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the South-East II-Lyon Ethics Committee (Comité de Protection des Personnes – CPP).
Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria. It can lead to heart failure, valve damage and stroke. It remains one of the most fatal heart diseases, with a death rate from 30 to 40%. The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases. Its treatment involves antibiotics, sometimes combined with surgery to repair damage to the heart valves. Despite advances in the prevention and treatment of other cardiovascular diseases, the incidence and mortality of endocarditis due to S. aureus increased in recent years, requiring the development of innovative therapies to tackle antimicrobial resistance.
The design of PHAXIAM’s multicenter phase 1 study in this indication received the necessary approvals from the ANSM and Sud-Est II-Lyon Ethics committee. The trial plans to involve 12 patients requiring replacement of an infected heart valve. Recruited across 4 French hospitals (Henri Mondor in Créteil, Hôpital Bichat-Claude Bernard in Paris, University Hospital of Nantes and University Hospital of Nancy), patients will be treated between 2 and 4 days with a combination of 2 anti-S. aureus phages, intravenously administered once or twice a day, until the day of surgery.
The primary objective of the study is to assess the safety of intravenous administration of PHAXIAM phages, to study their pharmacokinetics in the blood and to measure their concentration in the valve resected during surgery.
These data will be used to define the optimal intravenous administration schedule and will also be used for future phage therapy efficacy studies in indications requiring this administration route. The first results of the study are expected in mid-2024.
Pascal Birman, Chief Medical Officer of PHAXIAM Therapeutics, stated: “This phase 1 study was designed primarily to assess the safety and pharmacokinetics of our anti-S. aureus phages in the treatment of endocarditis infections. It also aims to validate the intravenous administration route, likely to improve patient exposure to our phages. Subject to positive data, we could use this administration method in subsequent efficacy studies on larger patient populations and in other clinical indications associated with a strong unmet medical need, such as bacteremia.“
Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, concluded: “These approvals enable us to take a major step forward in our most strategic S. aureus program, by positioning ourselves in a second, high value-added indication. With this new clinical trial, we are reaffirming our ambition to position phage therapy in indications with high unmet medical needs, where reducing patient mortality is a critical issue. The treatment of endocarditis infections caused by S. aureus using phage therapy could thus offer a major alternative and hope to many patients who have reached a therapeutic impasse.”
About PHAXIAM Therapeutics
PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.
PHAXIAM is listed on the Nasdaq Capital Market in the United States (ticker: PHXM) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
For more information, please visit www.phaxiam.com
SOURCE: Phaxiam Therapeutics
Post Views: 282
- Approval of study design by French ANSM and Ethics Committee
- Recruitment of 12 patients expected to start in Q4 2023 in 4 French centers
- First study results expected in mid-2024
LYON, France and CAMBRIDGE, MA, USA I October 24, 2023 I PHAXIAM Therapeutics (Nasdaq & Euronext: PHXM), a biopharmaceutical company developing innovative treatments for resistant bacterial infections, announces the approval of its phase 1 study clinical design in endocarditis infections caused by Staphylococcus aureus (S. aureus) by the French National Agency for the Safety of Medicines and Health Products (ANSM) and the South-East II-Lyon Ethics Committee (Comité de Protection des Personnes – CPP).
Endocarditis is an infection of the endocardium (inner lining of the heart) and valves, usually caused by bacteria. It can lead to heart failure, valve damage and stroke. It remains one of the most fatal heart diseases, with a death rate from 30 to 40%. The main cause of endocarditis infections, S. aureus, is responsible for around 30%1 of cases. Its treatment involves antibiotics, sometimes combined with surgery to repair damage to the heart valves. Despite advances in the prevention and treatment of other cardiovascular diseases, the incidence and mortality of endocarditis due to S. aureus increased in recent years, requiring the development of innovative therapies to tackle antimicrobial resistance.
The design of PHAXIAM’s multicenter phase 1 study in this indication received the necessary approvals from the ANSM and Sud-Est II-Lyon Ethics committee. The trial plans to involve 12 patients requiring replacement of an infected heart valve. Recruited across 4 French hospitals (Henri Mondor in Créteil, Hôpital Bichat-Claude Bernard in Paris, University Hospital of Nantes and University Hospital of Nancy), patients will be treated between 2 and 4 days with a combination of 2 anti-S. aureus phages, intravenously administered once or twice a day, until the day of surgery.
The primary objective of the study is to assess the safety of intravenous administration of PHAXIAM phages, to study their pharmacokinetics in the blood and to measure their concentration in the valve resected during surgery.
These data will be used to define the optimal intravenous administration schedule and will also be used for future phage therapy efficacy studies in indications requiring this administration route. The first results of the study are expected in mid-2024.
Pascal Birman, Chief Medical Officer of PHAXIAM Therapeutics, stated: “This phase 1 study was designed primarily to assess the safety and pharmacokinetics of our anti-S. aureus phages in the treatment of endocarditis infections. It also aims to validate the intravenous administration route, likely to improve patient exposure to our phages. Subject to positive data, we could use this administration method in subsequent efficacy studies on larger patient populations and in other clinical indications associated with a strong unmet medical need, such as bacteremia.“
Thibaut du Fayet, Chief Executive Officer of PHAXIAM Therapeutics, concluded: “These approvals enable us to take a major step forward in our most strategic S. aureus program, by positioning ourselves in a second, high value-added indication. With this new clinical trial, we are reaffirming our ambition to position phage therapy in indications with high unmet medical needs, where reducing patient mortality is a critical issue. The treatment of endocarditis infections caused by S. aureus using phage therapy could thus offer a major alternative and hope to many patients who have reached a therapeutic impasse.”
About PHAXIAM Therapeutics
PHAXIAM is a biopharmaceutical company developing innovative treatments for resistant bacterial infections, which are responsible for many serious infections. The company is building on an innovative approach based on the use of phages, natural bacterial-killing viruses. PHAXIAM is developing a portfolio of phages targeting 3 of the most resistant and dangerous bacteria, which together account for more than two-thirds of resistant hospital-acquired infections: Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa.
PHAXIAM is listed on the Nasdaq Capital Market in the United States (ticker: PHXM) and on the Euronext regulated market in Paris (ISIN code: FR0011471135, ticker: PHXM). PHAXIAM is part of the CAC Healthcare, CAC Pharma & Bio, CAC Mid & Small, CAC All Tradable, EnterNext PEA-PME 150 and Next Biotech indexes.
For more information, please visit www.phaxiam.com
SOURCE: Phaxiam Therapeutics
Post Views: 282
