AMR Bio has announced its launch as a clinical-phase biotechnology company, advancing the XF platform it acquired from Destiny Pharma after the company entered into administration last year.
EMV Capital PLC originally acquired the asset and associated intellectual property via its Moirai Acquisitions vehicle and subsequently renamed it to AMR Bio, establishing the brand as a vehicle to advance the XF platform.
The firm said in its release that it would be focused on preventing bacterial infections, which it called “one of the most urgent public health challenges.”
It will look to do this through the progression XF-73, a Phase III-ready, first-in-class topical antimicrobial designed to prevent post-surgical infections by eradicating harmful bacteria before surgery, through final-stage development and towards commercialisation.
The company’s 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 and demonstrated a 99.5% reduction in bacterial nasal carriage in patients in a Phase IIb trial.
Post-surgical infections are a significant burden on healthcare systems, costing about $10bn annually in the US.
XF-73 Nasal’s unique effectiveness may position it as a leader in pre-surgery decolonisation.
Additionally, XF-73 Dermal addresses severe skin and wound infections, including diabetic ulcers, within a global market projected to reach $9bn.
The overall wound care market is expected to exceed $20bn, driven by rising surgical procedures, chronic diseases and antimicrobial resistance.
The acquisition also included the transfer 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.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has already 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 company is also working towards a confirmatory Type C letter from the FDA, which is expected to provide formal guidance for the Phase III pathway for XF-73.
In its statement, AMR Bio added that it has appointed Cardinal Health as its US regulatory agent and is now a member of the BEAM Alliance, a network of biotech companies developing solutions to combat 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 III 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.
