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BARDA has awarded Summit, a drug discovery and development company, a contract worth up to $62 million over five years for the development of a new small-molecule antibiotic.
On Sep. 11, 2017, the US Department of Health and Human Services announced that its Office of the Assistant Secretary for Preparedness and Response (ASPR) is partnering with Summit Therapeutics, a UK-based drug discovery and development company focused on therapies for Clostridium difficile and Duchenne muscular Dystrophy, on the late-stage development of a new antibiotic for C. difficile infections that can occur during treatment for other bacterial infections, including anthrax, tularemia, and other biothreats.
Under the collaboration, Biomedical Advanced Research and Development Authority (BARDA), a component of ASPR, will provide up to approximately $32 million over two years to Summit Therapeutics to conduct two Phase III human clinical studies of its drug, ridinilazole. The contract potentially provides up to a total of $62 million over five years to the company.
In addition to the two Phase III studies, the company will manufacture ridinilazole for testing and conduct all regulatory activities involved in taking the drug to market. Under a cost-sharing arrangement in the contract, Summit will provide a significant portion of the funding needed for the development and regulatory approval of the drug.
Ridinilazole is an orally administered small-molecule antibiotic that exhibits a narrow spectrum of activity against C. difficile. It has received qualified infectious disease product designation and has been granted fast track designation by FDA. C. difficile infections occur most often in patients following the prolonged use antibiotics because such use can kill the human body’s natural gastrointestinal flora and allow overgrowth of C. difficile bacteria.