Cambridge biotech Microbiotica has achieved good results for its microbiome-based therapy for ulcerative colitis in a Phase Ib trial, which showed significantly better outcomes in patients who received the therapy versus placebo.
Ulcerative colitis is a form of inflammatory bowel disease affecting up to 1.3 million people in the U.S. that affects the colon and rectum. While drugs are available to manage symptoms, many patients have an incomplete response to current therapies or significant side effects leading to complications—meaning there is still a need for new, more effective treatments.
Microbiotica is a spin-out from the Sanger Institute near Cambridge in the U.K. and has a focus developing microbiome-based therapeutics. The company has developed MB310, an oral capsule containing eight different live strains of bacteria, to promote healing of the damaged gut epithelial barrier seen in people with ulcerative colitis.
In this Phase Ib study, 19 patients were treated with MB310 once daily plus standard care for 12 weeks, and 10 patients were given placebo treatment as well as standard care over the same time period. As well as disease outcomes, the trial investigators also assessed how well the therapeutic bacteria engrafted into the intestinal microbial community of the participants.
Overall, the study met its primary endpoint of demonstrating that it had a similar safety profile to placebo. In total, 63% (12 patients) of those in the treatment group achieved clinical disease remission versus 30% (3 patients) in the placebo group.
The researchers also showed that all eight strains of bacteria included in the therapy successfully engrafted into the gut microbiome of the patients in the treatment group and could still be detected after three months of follow up.
“The highly encouraging clinical remission rates at six months, is more impressive than any ulcerative colitis therapy I have seen to date,” said Robert Tansley, MBBS, Microbiotica’s chief medical officer, in a press statement.
“If confirmed in larger studies, MB310 has the potential to transform the management of ulcerative colitis by addressing a key factor behind the pathophysiology of the disease not currently treated.”
The company now plans to carry out a larger Phase II/III trial to try and confirm the efficacy findings seen in this study. The company is also testing another microbiome-based therapy in patients with melanoma, which is designed as a co-therapy to enhance the efficacy of immune checkpoint inhibitors and enable a durable, sustained anti-tumor response in patients who have not initially responded to this kind of immune-oncology treatment.
