About a year ago, when Seres Therapeutics Inc. won U.S. FDA approval of oral microbiome therapy Vowst (live fecal microbiota spores), the drug – meant to prevent recurrent Clostridioides difficile infection – was hailed as first in the space, and launch plans sounded ambitious. In July 2021, Seres inked a deal with Nestlé Health Science SA, of Lutry, Switzerland, to jointly commercialize Vowst in the U.S. and potentially Canada. But shares of Cambridge, Mass.-based Seres (NASDAQ:MCRB) closed May 8 at 75 cents, down 36 cents, or 32%, after the firm provided an update on sales, roughly flat quarter over quarter.
Acurx Pharmaceuticals Inc. continues to post positive data for its lead candidate ibezapolstat but that didn’t stop the stock from tumbling. The antibiotic outperformed vancomycin in a phase IIb study treating Clostridioides difficile infection (CDI). Vancomycin is a standard of care in the indication. Ibezapolstat eradicated fecal CDI at day 3 in 15 of 16 patients compared to vancomycin, which eradicated fecal CDI in 10 of 14 patients.
The bacterium Clostridioides difficile (C. difficile) forms organelles that help them defend against iron in the colon. According to a group of scientists from Vanderbilt University, this pathogen, which causes serious gastrointestinal infections, expresses fez genes to build structures called ferrosomes that store excess iron that is toxic to it. Its ferrosomes are surrounded by membrane and could be a target against this microorganism.
An experimental antibiotic was able to prevent recurrent Clostridioides difficile infections (rCDI) by killing bacterial spores as well as growing spores. Researchers from the University of Notre Dame reported their findings in the Proceedings of the National Academy of Sciences on May 8, 2023.
The supply chain for Seres Therapeutics Inc.’s oral microbiome therapeutic Vowst, formerly known as SER-109, to prevent recurrent Clostridium difficile infection (rCDI) is “well-established,” said David Arkowitz, the firm’s chief financial officer and head of business development. “It’s the same supply chain that we used for phase III [trials], and we’ve been manufacturing product for launch for some time.” Arkowitz spoke during a conference call with investors April 27, regarding the previous day’s U.S. FDA go-ahead for Vowst, cleared for adults with rCDI, including first recurrence following antibacterial therapy.
As expected, Seres Therapeutics Inc. gained U.S. FDA approval of the BLA for the oral microbiome therapeutic Vowst, formerly known as SER-109, for prevention of recurrent Clostridium difficile infection (rCDI), accepted for priority review in October of 2022 without an advisory committee meeting.
Mbiomics GmbH raised €13 million (US$14.2 million) in a first close of a series A round that will enable it to pivot from being a microbiome analytics firm to becoming a therapeutics developer.
Microbiome company Finch Therapeutics Group Inc. has suffered one blow after another in the past year with dwindling cash, delayed programs, a terminated deal and three workforce reductions. The latest reduction will bring the once healthy 189-person company down to a handful of employees, and it places the lead program – the oral microbiota product, CP-101, for Clostridiumdifficile infection – on the sidelines.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
Following Therapeutic Goods Administration approval of its first-generation donor-derived microbiome-based therapy, Biomictra, for recurrent Clostridioides difficile infection, Australia’s Biomebank is scaling up to meet increasing global demand for fecal microbiota products and is developing a more scalable second-generation synthetic product.
