UK-based drug discovery and development company Summit Therapeutics has secured a contract worth up to $62m to support the clinical and regulatory development of ridinilazole for the treatment of C. difficile infection (CDI).
Awarded by the Biomedical Advanced Research and Development Authority (BARDA), the new contract also includes the company’s planned Phase III development programme for ridinilazole.
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BARDA is an agency of the US Government's Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.
CDI is a bacterial infection of the colon that generates toxins, which causes inflammation and severe diarrhoea.
The Centers for Disease Control and Prevention claims C. difficile to be one of three pathogens that pose an immediate public health threat, and in the most serious cases can result in the death of the patient.
Summit’s ridinilazole is a highly selective, orally administered, small molecule antibiotic that focuses on treating the initial infection, as well as reducing recurrent disease, which is the major clinical concern in the treatment of CDI.
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By GlobalDataUnder the deal, the company will be entitled to receive an initial funding of $32m and an additional payment of $30m from BARDA.
Summit CEO Glyn Edwards said: “BARDA's selection of ridinilazole for an award is testament to ridinilazole's promising clinical and preclinical data package that indicate its potential as a front-line treatment of CDI that could reduce recurrent disease.”
A Phase II proof-of-concept clinical trial revealed ridinilazole to be highly preserving of the microbiome of patients compared with the standard of care, vancomycin.
The therapy achieved a significant reduction in rates of recurrent disease.
The current award will enable the company to begin two Phase III clinical trials for ridinilazole in the first half of next year.
