AMR Bio launches with Phase 3-ready antimicrobial targeting surgical infections
- XF-73 to step in where antibiotics are failing: a major global public health threat
- New leadership, focused strategy and clear path to commercialisation
We are delighted to announce our formal launch as a clinical phase biotechnology company focused on one of the most urgent public health challenges: preventing infection in an era where antibiotics are becoming less effective.
AMR Bio is advancing XF-73, a Phase 3-ready, first-in-class topical antimicrobial designed to prevent post-surgical infections by rapidly eliminating harmful bacteria before surgery.
Antimicrobial resistance contributes to nearly five million deaths each year[1], and without intervention could rise to an additional 10 million deaths annually by 2050[2]. As existing treatments become less effective, the emphasis is to shift from cure to prevention and to stop infections before they take hold.
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. Backed by EMV Capital PLC, a deeptech and life sciences specialist VC and EIS investor, AMR Bio was established as a focused vehicle to advance the XF platform, combining dedicated leadership, capital and discipline to progress XF-73 through final-stage development and towards commercialisation.
XF-73: Scientific Validation and Clinical Progress
Our lead product, XF-73 Nasal, is a gel 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.[3] In a 124-patient Phase 2b study, it demonstrated a 99.5% reduction in bacterial nasal carriage in patients undergoing open heart surgery and is now positioned for Phase 3 trials.
Regulatory progress includes the transfer of ownership and sponsorship of both the Investigational New Drug (IND) application for 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) also 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.
We are working towards a confirmatory Type C letter from the FDA, which is expected to provide formal guidance for the Phase 3 pathway for XF-73. We have also developed key partnerships, including the appointment of Cardinal Health as our US regulatory agent, and our membership of the BEAM Alliance, a network of biotech companies developing solutions to combat antimicrobial resistance.
New Leadership
AMR Bio’s leadership team brings over 50 years of combined expertise in antimicrobial development, regulatory affairs, and pharmaceutical commercialisation, including key experts involved in the original Phase 2 trials, such as former Destiny Pharma CEO Bill Love, who remains an advisor.
Nigel Brooksby, Executive Chair is a globally experienced life sciences executive and entrepreneur who has led and advised biotech and pharmaceutical companies at the highest level, including roles as Chairman, CEO, and Non-Executive Director. He is a former senior leader at Pfizer and Sanofi.
Dr William Rhys-Williams, Vice President, Research Operations, has extensive experience in the pharmaceutical industry, including developing technologies from discovery through to Phase 3 clinical trial development. He is a named inventor on 120 granted patents.
Market Opportunity
Post-surgical infections are a major burden on healthcare systems, costing approximately $10 billion annually in the United States alone.[4] With XF-73 Nasal’s unique attributes and effectiveness, it could become the market leader for pre-surgery decolonisation.
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[5], 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. We are now dedicated to advancing XF-73 through Phase 3 with a clear path towards clinical use.”
Dr Ilian Iliev, CEO of EMV Capital and Investment Director of AMR Bio, added:
“AMR Bio’s mission is focused and urgent. Its XF-73 asset represents a highly compelling investment opportunity with significant clinical and commercial potential, addressing the silent pandemic affecting every country and region.
“The experienced leadership is executing across regulatory strategy, manufacturing, commercial planning, and stakeholder engagement, with the goal of delivering for patients and shareholders alike.”
“Through EMV Capital’s EIS investment practice and Venture Build model we are providing hands-on support, while giving our investors the additional exposure to this exciting and socially impactful project”