The trillions of microbes that call us home –the human microbiome – perform critical functions that preserve our health including helping develop our immune system, manufacturing nutrients such as vitamins, and harvesting energy from the diet. Alterations of the human microbiome are increasingly recognized as a key factor in autoimmune, metabolic, infectious and many other diseases.
For millions of years, humans have co-evolved with this community of microbes, communicating in an ancient language that holds critical clues about how autoimmune and infectious diseases develop. This language is based on a system of signals that our resident microbes use to successfully colonize us, such as byproducts of bacterial metabolism and factors that bacteria use to adapt to human niches. Recent discoveries have shown that most of these signals do not lead to disease, rather, they promote our long-term survival.
Vedanta is developing a novel class of therapies that modulate pathways of interaction between the human microbiome and the host immune system. Vedanta was co-founded by PureTech Health and a group of world renowned experts in immunology and microbiology
Vedanta Biosciences, Inc. is a long standing supporter of Peggy Lillis Foundation and we are thrilled to have them as a Silver sponsor of our Inaugural Scientific Symposium on November 15. Their investigational product, VE303, is an orally administered, rationally-designed, defined bacterial consortium candidate being developed for high-risk Clostridioides difficile (CDI) infection. Vedanta is currently enrolling patients in a Phase 3 trial. Hear from Vedanta and learn more about investigational VE303 by registering for the symposium here https://buff.ly/3N9TvJ8
Last month we had the opportunity to again partner with School on Wheels of Massachusetts and assemble backpacks for Massachusetts students impacted by homelessness and poverty. Good luck to all students on the start of a new school year!
We have enrolled the first patient in the pivotal Phase 3 study of VE303 for the prevention of recurrent C. difficile Infection.
To our knowledge, this is the 1st registrational study of a Live Biotherapeutic Product for rCDI. An important milestone in our field
FDA has approved two Fecal Microbiota Products for rCDI, which provide patients access to an alternative to unregulated FMT
https://lnkd.in/emcFnSKh
Fecal Microbiota Products are made from donor feces. We believe this has inherent limitations around commercial scalability, risk of pathogen transfer, and batch-to-batch variability.
We hope to advance the field with DEFINED products which obviate the need for donors.
VE303 is a potential first-in-class Live Biotherapeutic Product consisting of an 8-strain defined bacterial consortium. "Defined" means the product has a specific, known composition of bacterial strains. Each capsule contains the same strains, at a consistent dose.
The Phase 3 study, RESTORATiVE303, is now underway in the US. We plan to expand enrollment to include >20 countries. It is a registrational study designed to support a BLA submission.
Our team did not have a blueprint for how to get an LBP ready for a registrational study. In the last couple of years, the process development, analytical development, manufacturing, and quality groups worked tirelessly navigating uncharted waters.
Thank you to our partners Biomedical Advanced Research and Development Authority (BARDA) and CARB-X, which have provided funding and expertise to advance the program.
https://lnkd.in/eqU2Femm
If you are attending #DDW2024 and interested in microbiome therapeutics check out Vedanta Biosciences, Inc.Emily Crossette, PhD 's presentation on VE303, a potential first-in-class Live Biotherapeutic Product for prevention of rCDI
Thank you CARB-X for the continued support of Vedanta Biosciences, Inc. antibacterial programs. This partnership helps advance VE707 into IND in preparation for a first-in-human study in prevention of MDRO infections.
Colorcon Ventures, the corporate venture fund of Colorcon® Inc., has invested in Vedanta Biosciences, Inc., a clinical stage life sciences company that designs and manufactures proprietary, orally delivered bacterial therapies.
Ali Rajabi-Siahboomi, Vice President and Chief Innovation Officer at Colorcon, said, “Vedanta Biosciences is aligned with Colorcon Ventures’ interest in emerging classes of drugs for oral administration. The company’s unique approach within microbial therapeutics has the potential to offer safer and more efficacious treatments for a number of indications. Vedanta has also revolutionized the manufacturing of defined bacterial consortia at scale, which adds significant value to the sector. We look forward to supporting Vedanta Biosciences as they realize the full potential of their platform technology.”
Press Release ➡️https://hubs.ly/Q02lRXmx0
