Seres Aims To File C. Diff Microbiome Drug On Single Pivotal Trial

10 Aug 2020

Competing with several other firms to bring the first microbiome-derived therapy to market, Seres says the magnitude of its Phase III efficacy compared to placebo may enough for registrational filing.

Clostridium difficile bacteria, 3D illustration. Spore-forming bacteria that cause pseudomembraneous colitis and are associated with nosocomial antibiotic resistance — Seres hopes to improve the standard of care in recurrent C. diff with a microbiome therapy

With positive top-line Phase III data in hand, Seres Therapeutics, Inc. thinks it is positioned to file its microbiome-derived candidate for recurrent Clostridium difficile infections for approval, which could make it the first approved microbiome therapy. First, however, the biotech needs to convince the US Food and Drug Administration that it has an adequate data package to obtain approval based on a single pivotal study.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

Start your 7-day free trial
Explore trusted news, analysis, and insights
Access comprehensive global coverage
Enjoy instant access – no credit card required

Start Free Trial

Already a subscriber?

Bristol’s Growth Plans Take A Hit As Cobenfy Fails As A Schizophrenia Add-On

23 Apr 2025

• By Mandy Jackson

Cobenfy is approved as a monotherapy, but failed in the adjunctive setting when combined with generic atypical antipsychotics, giving BMS a second Phase III failure in two weeks.

Sebela’s Tegoprazan Poised For GERD Market

23 Apr 2025

• By Jessica Merrill

Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).

Pipeline Watch: Eight Approvals And Three Phase III Readouts

23 Apr 2025

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

MetaVia’s ‘Safe’ Obesity Drug Resonates With Analysts, But Not Investors

22 Apr 2025

• By Joseph Haas

The biotech reported Phase I multiple-ascending dose data for its obesity drug for the second time in a week, but its safety and tolerability do not offset concerns about relatively unimpressive weight reduction.

Europe Pharma Heavyweights Call For Higher Drug Prices At Home

23 Apr 2025

• By Kevin Grogan

Sanofi's Paul Hudson and Novartis's Vas Narasimhan claim that while Europe is home to some of the most important biopharma companies in the world, its position is in jeopardy.