Infex’s novel AMR drug candidate MET-X receives FDA QIDP designation

Infex Therapeuics' novel AMR drug candidate MET-X receives FDA QIDP designation

This designation gives MET-X an accelerated U.S. regulatory pathway and an additional five-years of market exclusivity upon approval

Alderley Park, Cheshire, U.K. Infex Therapeutics, a leading anti-infectives specialist, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has granted Qualified Infectious Disease Product (“QIDP”) designation to MET-X, the Company’s broad spectrum Metallo-beta-lactamase (“MBL”)-inhibitor.

MET-X is a resistance bypass treatment which targets Gram-negative Enterobacterales. These pathogens produce MBL enzymes to deactivate beta-lactam antibiotics and evade antibiotic clearance of disease. MET-X blocks MBL resistance, restoring antibiotic activity. The drug is being developed to be one of the first broad-spectrum MBL inhibitors to address a wide range of bacterial species and drug-resistant strains. The treatment has shown best-in-class performance in animal studies to date and is currently undergoing pre-clinical safety evaluation with clinical studies planned for 2023. The management of antibiotic resistance in Gram-negative Enterobacterales is a World Health Organisation (“WHO”) critical priority.

QIDP designation is a U.S. incentive scheme designed to encourage the development of innovative new drugs to treat serious or life-threatening infections. The designation gives MET-X an accelerated FDA regulatory pathway, including priority review, fast-track designation and an additional five years of market exclusivity upon regulatory approval.

Antimicrobial resistance (“AMR”) is a serious and growing global threat to public health: the WHO has declared it as one of the top 10 global public health threats facing humanity. According to a recent study in The Lancet, AMR killed over 1.27 million people in 2019¹, more than HIV and malaria. By 2050² the annual number of deaths caused by AMR is projected to reach c. 10 million people, with an estimated US$1.2 trillion a year in additional health expenditure required to address the issue³.

Dr Pete Jackson, Executive Director of Infex, commented: “The award of the FDA’s QIDP designation is a significant step forward in the development of MET-X and is a strong endorsement and validation of the programme. Importantly, it provides MET-X with a fast-tracked U.S. regulatory pathway and an additional five-year exclusivity period. The world desperately needs new drugs to tackle the growing global threat of AMR, which is placing a significant burden on healthcare systems. The QIDP designation underlines MET-X’s potential to provide a vitally important, new and effective therapeutic option to patients with drug resistant infections who have exhausted all current treatment options.”               

1  The Lancet, 2022 Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis

2 UK government and welcome trust, 2014 Review on Antimicrobial Resistance

3 WHO