お知らせ • Jan 31
Phaxiam Provides an Update on the Deployment of Its Strategy to Maximize the Development Potential of Phage Therapy
PHAXIAM Therapeutics announced an update on the deployment of its ambitious strategy in the phage therapy market, enabling it to maximize its development potential. Accelerated development strategy in the dynamic phage therapy market: Antibiotic resistance (AMR) is a critical global public health issue, responsible for at least 1,270,000 deaths a year and, according to the World Health Organization, could cause 10 million deaths a year by 2050. Since its creation, PHAXIAM has been at the forefront of the fight against antibiotic resistance, thanks to its phage therapy approach and the development of a portfolio of phages targeting some of the most virulent bacteria (Staphylococcusaureus, Escherichiacoli and Pseudomonas aeruginosa). In parallel with the clinical development of its phages, the Company has treated, with success and a demonstrated clinical benefit, more than 130 patients under compassionate status since 2018, mainly in France, but also in other European countries. This clinical momentum testifies to the strong demand from physicians for PHAXIAM phages, which are produced in pharmaceutical quality (GMP = Good Manufacturing Practice). In this context of strong demand for phage therapy, PHAXIAM presented, in November 2024, a development strategy combining in parallel (1) the classical clinical development pathway (Phages Therapy Medical Product or PTMP) and (2) the commercialization of Individualized Phages Therapies (IPT) with GMP Phages. This dual development approach is widely used in other therapeutic fields, such as allergies, and is particularly well-suited to phage therapy. PHAXIAM benefits from several key assets for the deployment of the IPT model, including established expertise in the selection of the most effective GMP phages for bacterial strains, thanks to its phagogram, a robust tool for guiding physicians in the choice of phage-based treatments. The simultaneous development of PTMP and IPT models creates a virtuous circle for phage therapy: the commercial development in the IPT model will help finance PTMP programs and facilitate rapid uptake of future approved medicinal products; the clinical success in the PTMP model, from which the GLORIA clinical study in Prosthetic Joint Infections (PJI) has emerged, will strengthen the clinical and market acceptance of IPT therapies for clinical indications not yet covered by the PTMP approach.
Strategic collaboration with Technophage to accelerate the deployment of individualized GMP-phage therapy (IPT). With the aim of fostering the emergence of phage therapy, PHAXIAM approached several players specialized in phage therapy, in Europe and North America. These discussions led to the finalization of a strategic collaboration with Technophage, a Portuguese company specialized in the development and manufacture of GMP phages, enabling the implementation of individualized phage therapy (IPT) through the pooling of their GMP phage portfolios. By combining, (1) PHAXIAM's GMP phage portfolio and its advanced phagogram-based diagnostic capabilities, (2) with Technophage's GMP phage portfolio and GMP manufacturing expertise, this partnership aims to achieve a portfolio of 25 GMP phages by the end of 2025 and 35-45 GMP phages by the end of 2026. This expanded portfolio will target a minimum of 7 of the most critical pathogens, S. aureus, P. aeruginosa, E. coli, K. pneumoniae, A. baumannii, E. faecium and E. spp, which account for around 70% of resistant bacterial infections. The IPT model, based on the extension of individualized treatments in European countries, should generate and secure revenue in the short and medium term, with potential revenue of around €20 million in 2027 and potentially around €100 million in 2030, by treating patients in the most important European countries. The aim is to generate these targeted revenues with a very marginal increase in the company's fixed costs, thanks to the redeployment of internal resources and expertise to the IPT model. Continued development of the PTMP model through clinical studies and filing of new AAC applications: In parallel with the IPT model, PHAXIAM is pursuing PTMP clinical development. In particular, the Company continues to prepare the Phase II GLORIA study. PHAXIAM has already received IND approval from the US FDA in Fourth Quarter 2024 and has also submitted the clinical protocol to the main European health authorities, including the EMA and the UK MHRA. Subject to these approvals, expected during the first half of 2025, the GLORIA study will be conducted in 7 European countries (France, Germany, the UK, Spain, Italy, the Netherlands, Sweden) and in the United-States, positioning it as one of the most robust and broadest phage therapy studies in the world. Once these regulatory approvals have been obtained, the launch of the GLORIA study will depend on the company's future non-dilutive financial resources, currently being studied by the Company, and will be scheduled accordingly, possibly up to First Quarter 2026. The Company is also continuing recruitment for its Phase I Pharmacokinetic study in endocarditis, targeting patients with resistant S. aureus infections in the heart chambers and valves. First clinical results are expected in mid-2025. Finally, PHAXIAM also intends to extend the Compassionate Access Authorization (AAC) status available for its anti-S. aureus phages to other phages in its portfolio in 2025. Submission of the AAC for anti-P. aeruginosa phages, for Prosthetic Joint Infections, is expected by the end of January 2025.
