Periodic Reporting for period 1 - Phagediag (Fast, easy diagnostics for personalised phage therapy)
Periodo di rendicontazione: 2023-02-01 al 2024-01-31
Phage therapy (using bacteriophages to treat bacterial infections ) is among the most promising solutions for the antimicrobial resistance (AMR) crisis. Attempts with unspecific, pre-defined phage cocktails developed as classical medicinal products have failed to demonstrate efficacy in clinical trials (only 20-30% efficiency). In contrast, case reports with a personalized, specific approach using magistral preparations based on pre-manufactured phage API's (Active Pharmaceutical Ingredients) provided effective treatment (up to 85% success rate) and allowed for a targeted and flexible approach. Therefore, personalized phage therapy using magistral preparations of phages is among the most promising solutions to fight AMR. But to implement this approach a rapid diagnostic susceptibility test identifying the phages active on a specific pathogen(s) involved in an infection is required. Existing classical lab techniques for phage susceptibility testing are too time consuming and too labour intensive to use as standard technique in a hospital microbiology lab. Besides this they are also difficult to interpret and are not multiplexed. This is not feasible with current laboratory techniques for in vitro phage susceptibility testing, which are slow, difficult to interpret, require excessive labour and demand academic expertise which is rare to find in clinical laboratories. Vésale Bioscience has developed the “Phagogram”, the first automated in-vitro diagnostic tool that enables a fast determination of bacteriophages suitable for treating a particular bacterial infection. It consists of a basic test kit (a disposable well plate with a collection of fixed phages and a set of reagents), a high-performance luminometer and a dedicated software that proposes the best matching phage cocktail to treat the patient. Compared to the current diagnostic methodologies, which take up to 3 – 4 days, the Phagogram compares the activity of up to 90 phages on a bacterial culture within 3 – 4 hours, making phage susceptibility testing accessible for hospital microbiology labs and enabling personalized therapy on a routine basis
The concept of the automated phagogram was developed over the past years to a point where a working prototype was demonstrated. During the last year the industrial production of the prototype was planned and tested. This further development was performed using a rigid schedule guided by the European Regulation for developing, manufacturing and testing of In Vitro Diagnostic tests. Simultaneously with the dossier for the test equipment and material, a second workplan was completed developing the software program necessary for the management and functioning of the test system. The company is now ready to start the validation tests on the Phagogram. This validation, amongst others, contains a clinical validation of the susceptibility test in different European hospitals which will demonstrate the performance and reliability of the test and its predictive value for composing the right bacteriophage cocktails to treat in a personalized model drug multiresistant infections. At the end of this development the full dossier, including all documentation concerning manufacturing and validation of the test, will be presented to a competent Notified Body in order to audit the material and to obtain the CE-marking of the Phagogram as IVD.
Personalized phage therapy is today probably the most promising treatment solution for antibiotic multi-resistant (AMR) bacterial infections.The Phagediag susceptibility test is developed as diagnostic tool enabling the identification of the best phages to treat a specific resistant infection. With a high diagnostic accuracy , the automated Phagogram test is an effective tool to install a correct phage therapy reducing the burden and impact of an AMR infection , alleviating not only the human suffering, but the economic burden to entire social security systems covering medical expenses and workforce lost due to these infections. Reducing as well long term consequences of antibiotic treatment and saving lives by providing a fast diagnostic (3-4 hours compared to actual 3-4 days). Internally for Vesale Bioscience, the Phagogram plays a central role in our strategy since finalizing, validating and fulfilling the regulatory pathway of the Phagogram will enable us to its final industrialization converting us in a leader position by distributing this unique diagnostic product. Additionally, this previous knowledge starting with 4 bacteria responsible for about 70% of all AMR infections will give us the expertise to expand the technology to new strains and applications. Summarizing, the automated Phagogram will revolutionize the market by providing a way of making personalized phage medicine possible thanks to the implementation of this highly accurate diagnostic step. Once personalized cocktails are made possible, most biotechnology companies working in the field of phage btherapy are expected to change their approach, at least partially, to also become able to provide this type of methodology (much more efficient and aligned with the trend in medicine towards adapting to the specific patient needs)