Exhibit 99.1
Summit Therapeutics plc
(‘Summit’ or ‘the Company’)
Summit Awarded Additional $12 Million by BARDA for Phase 3 Development
Programme of Ridinilazole for the Treatment ofC. difficile Infection
| | • | | Brings Total Committed Funding Under BARDA Contract to $44 Million |
Oxford, UK, and Cambridge, MA, US, 16 August 2018 – Summit Therapeutics plc (NASDAQ:SMMT, AIM:SUMM), a leader in antibiotic innovation, today announces that it has been awarded an additional $12 million under its contract with the Biomedical Advanced Research and Development Authority (BARDA), a division of the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response. The funds will support the Phase 3 development programme for ridinilazole, the Company’s precision new mechanism antibiotic for the treatment ofC. difficile infection (‘CDI’).
“BARDA’s continued support underlines the promise ridinilazole has as a potential front-line CDI treatment option which can treat the initial infection and address the key clinical issue of recurrent disease,” commented Mr Glyn Edwards, Chief Executive Officer of Summit. “We look forward to the planned initiation of the Phase 3 clinical trials which remains on track for the first quarter of 2019.”
Today’s award represents the first of three optional awards to be exercised under the BARDA contract. It brings the total committed BARDA funding to $44 million, which includes the base package of $32 million announced in September 2017. If BARDA exercises its remaining options in full, the total funding under the contract would increase up to $62 million. The $12 million in funding will be drawn down to specifically support drug manufacturing activities required for the submission of marketing approval applications and other regulatory activities.
About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly in the wider community with over one million estimated cases of CDI annually in the United States and Europe. CDI is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation and severe diarrhoea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad-spectrum antibiotics, which cause further damage to the gut flora and are associated with high rates of recurrent disease. Reducing disease recurrence is the key clinical issue in CDI as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the US.
About Ridinilazole
Ridinilazole is a small molecule antibiotic that Summit is developing for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a targeted spectrum of activity that combined a potent bactericidal effect against all clinical isolates of C. difficile tested with minimal impact on other bacteria that are typically found in the gut microbiome. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole, an orally administered small molecule, has received Qualified Infectious Disease
