Trial design. The study will be comprised of up to 4 groups, each of 50 CDI patients, as described in Table 16. An N=50 per arm would provide sufficient data to allow for selection of SMT19969 dosing regimen for Phase 3 and would also provide more robust data on rates of recurrent CDI. Vancomycin will be the comparator since it is recommended as the best treatment for the full range of disease severity that is likely to be encountered in the trial. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 3 pages were omitted. [**]
Appears in 2 contracts
Sources: Translation Award Funding Agreement (Summit Therapeutics PLC), Translation Award Funding Agreement (Summit Corp PLC)