Aim­ing to jump ahead of Big Phar­ma heavy­weights, Seres moves to fi­nal­ize C. dif­fi­cile FDA pitch

C. dif­fi­cile pro­grams have flus­tered Big Phar­ma com­pa­nies and biotechs alike, but Seres is bar­rel­ing for­ward with its own mi­cro­bio­me treat­ment af­ter it says it’s con­firmed a Phase III win.

Seres un­veiled the re­sults of the open-la­bel ex­ten­sion study ECOSPOR IV ear­ly Tues­day, which was in­ves­ti­gat­ing drug can­di­date SER-109 to pre­vent rC­DI, or re­cur­rent C. dif­fi­cile in­fec­tion over the course of 24 weeks. It fol­lows a pre­vi­ous study, ECOSPOR III, which to­geth­er con­clude Seres’ Phase III de­vel­op­ment pro­gram and have it ready to start a rolling BLA sub­mis­sion, ac­cord­ing to the biotech.

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