Collaboration with US-based non-profit underlines potential of Company’s ulcerative colitis work

Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, today announces it has received project funding from the Crohn’s & Colitis Foundation, as part of their IBD Ventures program, for the development of therapies to treat inflammatory bowel disease (IBD). The project, to support the ongoing development of Microbiotica’s Live Bacterial Therapeutic (LBT) MB310 for the treatment of ulcerative colitis (UC), was funded following an extensive review process including industrial and clinical key opinion leaders, and is strong recognition of Microbiotica’s unique capabilities in the discovery and development of microbiome-based therapies.

The funding will be used to progress the development of MB310 through cGMP manufacturing to enable an Investigational New Drug (IND) application, allowing progression into a first-in-human clinical trial. As important will be the close collaboration with the Foundation, which has developed a unique set of resources to accelerate IBD research, such as clinical research networks and IBD Plexus®.

MB310 is a fully defined LBT comprising 10 bacterial species, identified using Microbiotica’s unique microbiome discovery platform in combination with a best-in-class faecal microbiota transplantation (FMT) study undertaken by Microbiotica and the University of Adelaide. Numerous studies have shown the link between UC and the gut microbiome, with several FMT studies validating the approach of changing the microbiome composition leading to clinical remission by reducing bacteria-driven inflammation. Pre-clinical testing shows that MB310 can address key UC disease pathologies, with the ability to repair the epithelial barrier and restore immune homeostasis.

Mike Romanos, Co-Founder and CEO of Microbiotica, said:

“We’re delighted that a prestigious organisation, such as the Crohn’s & Colitis Foundation, has awarded us this funding. It serves as an endorsement of our precision medicine approach and our work to harness the microbiome to treat UC. The Foundation’s expertise and network within this disease area will be invaluable in supporting the development of MB310 through to clinical studies.”

“Ulcerative Colitis is an increasing burden on society, and a growing disease for which there needs to be improved treatment options. We believe our therapeutic candidate has the potential to provide a much-needed non-immunosuppressant-based treatment option for those suffering with UC.”

Dr. Andrés Hurtado-Lorenzo, Vice President, Translational Research Programs for the Crohn’s & Colitis Foundation, commented: “The work undertaken by Microbiotica in the UC area is most impressive. We believe their approach to reintroduce microbial diversity into the gut is compelling and may present a really important opportunity to treat the underlying condition, not just offer relief for the symptoms.”

Ulcerative colitis is the most common form of inflammatory bowel disease and affects millions of people worldwide. There is no known cure for UC and current treatments options are aimed at relieving symptoms associated with the condition. Immunosuppressant drugs can be an effective treatment, but often carry the risk of increased chance of cancer and infection.