The primary endpoint of the study will be Objective Response Rate, and secondary endpoints include Duration of Response, Progression-Free Survival, Overall Survival and safety parameters.
Part one of the study will enroll up to 20 patients in each of two dose cohorts: 500mg/m2 and 750mg/m2.
SYNB1020 was safe and well tolerated in subjects in multiple ascending dose cohorts who received total daily doses of up to 1.5×1012 CFU for 14 days.
In the MAD component of the Phase 1 study, daily dosing of SYNB1020 over 14 days in healthy volunteers enabled identification of a dose-response relationship between SYNB1020 oral administration and changes in a nitrogen endpoint in plasma which was found to be statistically significant in the highest dose cohort compared to placebo.
In addition, viability and evidence of mechanistic activity of the Synthetic Biotic was demonstrated in feces of subjects who received SYNB1020, but not in control subjects.
In part two of the study, Nu Cana will select one of these doses and enroll at least an additional 24 patients at the selected dose.
Nu Cana expects to announce interim data from this study in 2018.