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Summit Therapeutics Inc.
(Summit, the Company or the Group)
Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2020
Cambridge, MA, September 29, 2020 - Summit Therapeutics Inc. (NASDAQ: SMMT) today reports its financial results and provides an update on its operational progress for the second quarter and six months ended June 30, 2020.
Ridinilazole for C. difficile Infection (CDI)
Summit published data from its Phase 2 clinical trial of ridinilazole evaluating the effects of a narrow-spectrum (ridinilazole) or broad-spectrum antibiotic (vancomycin) on intestinal bile acid profiles. This was the first study to demonstrate in humans the relationships between Clostridioides difficile antibiotic treatment choice and bile acid metabolism both during therapy and after treatment cessation. The results indicated that ridinilazole maintained an intestinal bile acid profile associated with a lowered risk of recurrence. The data were published in the American Journal of Physiology Gastrointestinal and Liver Physiology.
As of August 31, 2020, Summit had enrolled a total of 369 patients into its Phase 3 Ri-CoDIFy clinical trials of ridinilazole. Below is a table outlining the enrollment statistics by calendar quarter and for this past July and August since the opening of the trials in February 2019.
Number of patients enrolled
Cumulative Patients Enrolled
Due to the uncertainties surrounding COVID-19, Summit is withdrawing public commentary on the timing of completion of the Phase 3 Ri-CoDIFy clinical trials. The Company plans to publicly update stakeholders quarterly as to enrollment status.
The Ri-CoDIFy clinical trials aim to support application for marketing approval of the precision antibiotic ridinilazole in the United States and other territories and the goal of it being used as a first-line treatment for CDI by:
testing for superiority over the current standard of care, vancomycin, in the primary endpoint of sustained clinical response at 30 days after treatment has ended;
generating health economic data to support ridinilazoles commercial launch, when as and if approved by regulatory authorities; and
undertaking microbiome and metabolome analysis that aims to show ridinilazoles impact on the gut microbiome and bile acids composition
BARDA is supporting the Phase 3 clinical trials and regulatory development of ridinilazole with a financial award of potential funding of up to $72.5 million. As of June 30, 2020, an aggregate of $46.6 million had been received.
The following information was filed by Summit Therapeutics Plc (SMMT) on Tuesday, September 29, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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