Surotomycin demonstrated non-inferiority to vancomycin for C. difficile
clinical response at the end of the trial. It did not demonstrate superiority to vancomycin for the clinical response over time or sustained clinical response rate.
To be included in the study, participants were required to sign a consent form, be 18 years or older and 90 or younger, have diarrhea at least 3 times throughout 1 day, or 200 mL or liquid stool if using a rectal device, test positive for C. difficile
, and if female, must not be pregnant or nursing.
Based on the trial results, the development program of surotomycin has been discontinued.
This follows previously reported results of a parallel phase 3 trial
in which surotomycin failed to meet non-inferiority criteria relative to vancomycin for primary and key secondary endpoints.
The primary outcomes in the parallel study included the proportion of subjects with a clinical outcome of cure 2 days after the last dose of study drug, while the secondary outcome measures were to demonstrate a clinical response over time based on the length of time it takes for subjects to fail treatment, recur, die or become lost to follow-up day until day 40 to 30 days after the last dose of study drug—and the proportion of subjects who sustain a clinical outcome of cure until day 50, 30 days after the last dose of study drug.
In this second phase 3 trial, surotomycin demonstrated non-inferiority to vancomycin for C. difficile
clinical response at end of treatment, similarly to vancomycin for a sustained clinical cure.
A version of this article originally appeared on MD Magazine.com.
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