Summit Therapeutics Wins $62M to Spur Development of Ridinilazole for C. Difficile

The Biomedical Advanced Research and Development Authority (BARDA), of the U.S. Department of Health and Human Services office has awarded Summit Therapeutics a contract worth up to $62 million to support the development of ridinilazole for the treatment of Clostridium difficile.

According to the Centers for Disease Control and Prevention, C. difficile is posing an immediate public health threat. Studies have estimated the infection’s annual acute costs at $4.8 billion in the United States. Despite in-hospital fatalities decreasing over the past decade, patient infection rates are increasing.

Ridinilazole, a highly selective, novel class antibiotic, is aimed at treating both the initial infection and reducing recurrent disease.

“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,” said Glyn Edwards, chief executive officer, Summit.

The BARDA contract includes an approximate 12-month base period with federal government funding of approximately $32 million. In addition, there are 3 option work segments that if exercised fully by BARDA, would increase the total funding under the contract to approximately $62 million.

Activities in these 3 option work segments include the completion of enrollment and treatment in the 2 planned phase 3 clinical trials, and other activities related to the preparation for the potential submission of application for marketing approval for ridinilazole.

With the contract award, Summit remains on track to initiate 2 phase 3 clinical trials of ridinilazole for C. difficile in the first half of 2018. The company continues to explore various funding options for completion of its phase 3 clinical development program with these including entering into a collaboration with a third party, equity financing or securing additional non-dilutive funding from government entities and philanthropic, non-government and not for profit organizations.

Ridinilazole is an orally administered, small molecule antibiotic developed by Summit specifically for the treatment of C. difficile. In preclinical efficacy studies, the drug exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested.

“All the results to date point to ridinilazole being a step forward for the treatment of C. difficile infection. By targeting only some clostridia, including C. difficile, and leaving the healthy gut bacteria undamaged, ridinilazole could markedly reduce the chance of recurrent infection,” said Mark Wilcox, consultant microbiologist and head of microbiology research and development at the Leeds Teaching Hospitals NHS Trust, professor of medical microbiology at the University of Leeds, and Public Health England's lead on C. difficile.

In a phase 2 proof of principle study in C. difficile patients, ridinilazole was highly preserving of the microbiome of patients and presented statistical superiority in sustained clinical response rates (SCR) compared to the standard vacomycin. In the trial, SCR was defined as clinical cure at end of treatment and no recurrence of C. difficile within 30 days of the end of therapy.

Ridinilazole received Qualified Infectious Disease Product (QIDP) designation and has been granted fast track designation by the US Food and Drug Administration (FDA).

The project is funded in part with federal funds form the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; and Biomedical Advanced Research and Development Authority. Summit will file Form 6-K with the US Securities and Exchange Commissions.

A press release is made available.

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