An office of the U.S. Department of Health and Human Services (HHS) recently announced that it would provide up to $62 million over the next five years to Summit Therapeutics for the development of an antibiotic to combat Clostridium difficile infections (CDI).
The secondary infection can occur in patients being treated for bacterial infections such as anthrax and tularemia, often after prolonged use of antibiotics, which kill the body’s natural gastrointestinal flora.
The frug, Ridinilazole, is an orally administered small molecule antibiotic. It has received Qualified Infectious Disease Product (QIDP) designation and been granted Fast Track designation by the U.S. Food and Drug Administration (FDA).
The Biomedical Advanced Research and Development Authority (BARDA), a component of HHS’ Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide up to $32 million over two years to Summit Therapeutics. Summit will also provide a large portion of the necessary funding.
Summit Therapeutics, which is headquartered in Oxford, UK, will conduct two Phase 3 human clinical studies of Ridinilazole. The company will also manufacture the drug for testing and conduct all regulatory activities needed to get the drug to market.
“To save lives from biothreats, whether it’s anthrax or tularemia, doctors must be able to treat not just the biothreat itself but also opportunistic secondary infections that may occur,” BARDA Director Rick Bright said. “We are continually seeking innovative ways to protect health from all biodefense threats. Partnering to develop drugs that treat biothreats, as well as common, serious infections, has proven to be an innovative, sustainable business model for industry and the federal government.”