Seres Therapeutics has secured priority review designation from the US Food and Drug Administration (FDA) for SER-109, its investigational oral microbiome therapeutic for the prevention of recurrent C. difficile infection (rCDI).

The biologics license application (BLA) of the American microbiome therapeutics company for SER-109 has been given a prescription drug user fee act (PDUFA) action date of 26 April 2023.

Lisa von Moltke — Seres Therapeutics Chief Medical Officer said: “We are delighted by the FDA’s BLA acceptance for priority review, as we believe that SER-109 has the potential to fundamentally transform the management of rCDI.

“We are working closely with the FDA to bring forth this entirely new treatment modality alongside our collaborator, Aimmune Therapeutics, Inc., a Nestlé Health Science Company.”

According to Seres Therapeutics, SER-109 is made up of purified Firmicutes spores. SER-109 is designed for lowering the recurrence of C. difficile infection through the modulation of the disrupted microbiome to a state that resists the colonization and growth of C. difficile.

SER-109 has both breakthrough therapy designation as well an orphan drug designation for the prevention of recurrent C. difficile infection.

The BLA of SER-109 is underpinned by the findings of a completed phase 3 clinical development program that comprises the ECOSPOR III and the ECOSPOR IV trials.

Eric Shaff — Seres Therapeutics President and CEO said: “We are working as quickly as possible to bring this first-ever oral microbiome therapeutic to patients most in need, if approved.

“Today’s milestone is the result of tremendous hard work and perseverance by our team, and we look forward to collaborating with the FDA through the ongoing review process.”

In July 2021, Seres Therapeutics signed an agreement with Nestlé Health Science to jointly commercialize the oral microbiome therapeutic in the US and possibly in Canada.

  Aimmune Therapeutics, C. difficile infection, Eric Shaff, Lisa von Moltke, Nestlé Health Science, SER-109, Seres Therapeutics, US Food and Drug Administration