Approximately one and one half million people are affected by ulcerative colitis (UC) worldwide. It is an inflammatory bowel disorder with, as of yet, no known cause. There are, however, several causes under consideration, namely genetics, environmental factors, and dysfunctional immune systems caused by the loss of beneficial bacteria or the accumulation of harmful bacteria.
Searching for Long Term Remission
As one of its immuno-oncology programs, the biopharma company, Microbiotica, recently announced dosing of the first of 30 adult patients in its Phase 1b First-in Human trial called COMPOSER 1.
The international trial will be investigating MB310 which is an eight-strain live biotherapeutic product developed to treat mild or moderate UC patients. The oral capsules have been developed to provide long remission minus severe adverse effects.
The trial will consist of patients across twenty sites including Austria, UK, Bulgaria, Spain, and Poland with initial data expected in late 2025. Patients will take two capsules of the active study medication or placebo together with their daily standard dose and will be followed for an additional 12 weeks. The trial will measure the degree to which specific bacterial strains within MB310 “take root” in the patient’s intestinal tract.
Walter Reinisch, Professor and principal investigator for the study, offered that microbiota dysregulation, (dysbiosis) which is an imbalance in the microorganisms in the body, may lead to a series of health issues. There are many factors that may cause dysbiosis such as a change in diet, disease or antibiotic use. The professor commented further that the study provides an opportunity to rebalance microbiota and potentially induce disease remission on a long-term basis.
Preclinical studies of MB310 demonstrated that it promotes gut healing. MB310 brings about regulatory T cell response by which white blood cells regulate the reaction of the immune system to substances in and outside of the body.
Microbiotica sees the trial as leading to new treatments for patients with UC.
Source: Microbiotica begins human trials for ulcerative colitis treatment – PharmaTimes
