Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

Seres Therapeutics to Launch New Clinical Trial for Microbiome Drug

By Ryan Bushey | March 17, 2017

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

 

Related Articles Read More >

Zoliflodacin wins FDA nod for treatment of gonorrhea
FDA approved ENFLONSIA for the prevention of RSV in Infants
First clinical study results of Dupixent for atopic dermatitis in patients with darker skin tones 
Labcorp widens precision oncology toolkit, aims to speed drug-trial enrollment
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE