Lukas Bethlehem, Former Scientist PharmaBiome AG, shared a post on LinkedIn:
“Exciting news for translating the microbiome into human health!
I’m more than happy to share the results of our successful Phase I clinical trial, now available as a preprint on medRxiv:
“Live biotherapeutic product exhibits similar efficacy and superior engraftment to same donor fecal microbiota transplant for recurrent Clostridioides difficile infection.”
This first-in-kind trial directly compares a 15-strain defined live biotherapeutic product (LBP) to the full-spectrum donor-derived FMT it was originally isolated from, to treat patients with recurrent Clostridioides difficile infection (rCDI).
The consortium was manufactured using a novel, cost- and space-efficient platform for LBP development. To help accelerate and democratize translation in the field, we share the full documentation, including IND, pre-IND, and MBRs, alongside the preprint.
Key findings:
- In vitro–manufactured gut bacteria worked as well as FMT and showed better engraftment.
- Selecting LBP strains by engraftment linked to treatment success is a powerful strategy to design minimal efficient sets of microbiota therapeutics.
- Cost- and space-efficient manufacturing of LBPs is feasible and can enable faster, more inclusive translational microbiome development.
If you are interested in translating microbiome findings into human trials, I’d be happy to connect!
Useful links:
Single-strain tracking algorithm.”
Jolanta Gore-Booth, Founder/Director at Global Healthcare Projects, shared a post by Lukas Bethlehem, adding:
“This is very important news as we start to translate the Microbiome into human health. If I am honest I didn’t realise that we were at this stage and it makes our Inside Out campaign even more relevant! We will keep you updated.”
Title: Live biotherapeutic product exhibits similar efficacy and superior engraftment to same donor fecal microbiota transplant for recurrent Clostridioides difficile infection
Authors:Lukas Bethlehem, Lorenza Bartu, Gina Marke, Phyu Mar, Sari Feldman, Joseph Eggers, Constantin Ruprecht, Graham Britton, Varun Aggarwala, Gerold Bongers, Zhihua Li, Nancy Yang, Elizabeth Hohmann, Ilaria Mogno, Jeremiah J Faith, Ari Grinspan
Read the Full Article.
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