UTILITY therapeutics is focused on developing and commercialising antibiotics in the US, to address the significant threat faced by healthcare systems and patients from multi-drug resistant bacterial infections. The World Health Organisation has stated that antibiotic resistance is one of the biggest threats to global health, food security, and development today.
UTILITY’s lead product is mecillinam, and its oral pro-drug pivmecillinam, for the treatment of complicated urinary tract infections (cUTI) and uncomplicated urinary tract infections (uUTI). Mecillinam and pivmecillinam are the most commonly used systemic antibiotics in certain markets for urinary tract infections, and continue to demonstrate low levels of microbial resistance, a consistent and well understood safety profile, and high success rates based on real world evidence.
Both mecillinam and pivmecillinam have received Qualified Infectious Disease Product Designation (QIDP) from the US Food and Drug Administration (FDA), for the treatment of cUTI, and pivmecillinam received the designation for uUTI. The designations provide UTILITY with the possibility of receiving priority review, and a five-year extension of market exclusivity.
Following the QIDP designation, UTILITY also received an investigational new drug approval (IND) for both mecillinam, and pivmecillinam from the FDA. This designation enables UTILITY to commence clinical development in the US, for the treatment of both cUTI and uUTI.