An experimental treatment for clostridium dificile infections is getting a second chance.
Seres Therapeutics will launch a new Phase 2 clinical trial for SER-109, an oral capsule being developed for patients with multiply recurrent Clostridium Difficile (C.Diff) infections. The therapy failed a clinical trial last year because the drug didn’t reduce the relative risk of C. Diff recurrence compared to the placebo, according to Xconomy.
Seres was able to restart these trials after consulting with the Food and Drug Administration.
Both organizations agreed that first experiment missed its mark because Seres missed the mark when it came diagnosing the C. diff infection status of patients throughout the study and gave subjects a suboptimal dose of SER-109, wrote FierceBiotech.
A number of measures will be implemented to ensure accurate results this time.
This new randomized, placebo-controlled analysis will involve an approximate 320 patients with the multiply recurrent form of the bacterial infection.
Investigators will administer a total SER-109 dose to patients in this arm over three days, which is an estimated 10-fold higher dose than the previous study. Volunteers will be evaluated over 24 weeks with the primary endpoint being a comparison between the recurrence rate for those receiving doses of the drugs versus placebo after an eight week period.
Stool sample diagnostics will be used to verify these findings as well.
The company will start this study later this year.
Filed Under: Drug Discovery
