AMR Bio has launched as a clinical phase biotechnology company focused on antimicrobial resistance.
The company is advancing XF-73 Nasal, a phase 3-ready, first-in-class topical antimicrobial gel designed to prevent post-surgical infections by rapidly eliminating harmful bacteria before surgery. Post-surgical infections are a major burden on healthcare systems, costing approximately $10bn annually in the United States alone.
Antimicrobial resistance contributes to nearly five million deaths each year and without intervention could rise to an additional ten million deaths annually by 2050. As existing treatments become less effective, the emphasis is to shift from cure to prevention and to stop infections before they take hold.
The gel is applied to a patient’s nose prior to surgery to rapidly reduce harmful bacteria in the nose – widely considered the leading cause of post-surgical infections.
A phase 2b study of 124 patients showed a 99.5% reduction in bacterial nasal carriage in patients undergoing open heart surgery and XF-73 Nasal is now positioned for phase 3 trials.
Beyond this, XF-73 Dermal targets severe wound and skin infections, including diabetic ulcers and trauma-related wounds, which sit within a global dermal market estimated to grow to $9 billion annually. The broader wound care market is estimated to exceed $20 billion globally, driven by rising rates of surgical procedures, chronic diseases, and antimicrobial resistance.
Nigel Brooksby, Executive Chair of AMR Bio, said: “Antimicrobial resistance is a looming catastrophe. Bacteria and other microbes are evolving to withstand the medicines designed to kill them, turning routine illnesses into potentially serious, hard-to-treat conditions.
“The tools we have historically relied on to control infectious disease are slowly being outsmarted by nature, and preventing infections before they develop is becoming ever more critical.
“XF-73 has already demonstrated strong clinical results, and has the potential to transform patient impact through a no-resistance, 24-hour treatment window ahead of surgical operations – in turn potentially reducing the need for antibiotics.”
Regulatory progress includes the transfer of ownership and sponsorship of both the Investigational New Drug (IND) application for XF-73 Nasal and the pre-Investigational New Drug (pIND) application for Dermal, along with the associated Qualified Infectious Disease Product (QIDP) designation and Fast Track status.
In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) granted XF-73 Nasal an Innovation Passport under the Innovative Licensing and Access Pathway (ILAP), supporting an accelerated route to market and faster patient access for medicines targeting life-threatening conditions.
The XF platform was acquired by AMR Bio from Destiny Pharma following its entry into administration, presenting a valuable opportunity to secure a clinically validated, late-stage asset with significant prior investment.