AMR Bio Launches to Advance Phase 3-Ready Antimicrobial XF-73

AMR Bio has launched as a clinical-stage biotechnology company to develop XF-73, a Phase 3-ready topical antimicrobial intended to prevent post-surgical infections. The company was formed to acquire and advance the XF platform from Destiny Pharma following its entry into administration, backed by EMV Capital as its lead investor. XF-73 is being positioned as a preventive option in the context of rising antimicrobial resistance, which is associated with millions of deaths annually and increasing pressure on health systems.

The lead candidate, XF-73 Nasal, is a gel applied in the nose prior to surgery to reduce bacterial carriage, a known source of post-surgical infections. In a 124-patient Phase 2b trial in open-heart surgery, the product achieved a 99.5% reduction in nasal bacterial carriage and is now being prepared for Phase 3 studies. Regulatory progress includes transfer of the U.S. IND and pre-IND applications for nasal and dermal indications, retention of Qualified Infectious Disease Product and Fast Track designations, and an Innovation Passport from the UK MHRA under the ILAP framework. AMR Bio is seeking a confirmatory Type C letter from the FDA to finalize the Phase 3 pathway and has appointed Cardinal Health as its U.S. regulatory agent while joining the BEAM Alliance network.

AMR Bio’s leadership team includes Executive Chair Nigel Brooksby, a former senior executive at Pfizer and Sanofi with extensive board and leadership experience, and Vice President of Research Operations Dr. William Rhys-Williams, an industry veteran and named inventor on more than 100 patents. Former Destiny Pharma CEO Bill Love remains involved as an advisor. Beyond XF-73 Nasal for pre-surgical decolonization, the company is advancing XF-73 Dermal for severe wound and skin infections, including diabetic ulcers and trauma-related wounds. AMR Bio cites an estimated annual cost of approximately $10 billion for post-surgical infections in the United States, with global dermal and wound care markets projected in the high single- to tens-of-billions of dollars, as key drivers for further development and potential commercialization.

Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!

Sign up now!

  • <<
  • >>

Join the Discussion