VIB spin-off MRM Health receives approval for phase 2 clinical trial in pouchitis
VIB spin-off MRM Health, founded in 2020, has received approval from the Federal Agency for Health and Medicinal Products (FAGG) to start a Phase 2 clinical trial involving their novel therapeutic MH002 for the treatment of pouchitis in ulcerative colitis patients.
In patients with severe ulcerative colitis, a last resort option to alleviate symptoms is to perform a colectomy and to replace the removed parts of the bowel with a surgically reconstructed pouch. This so-called pouch allows patients to function normally without needing a stoma. Unfortunately, up to 50% of patients with a pouch suffer from pouchitis within the first 1 to 2 years after surgery. Disease mechanisms include impaired gut wall barrier function linked to gut microbiome dysbiosis, translocation of microbial products and resulting immune cell activation, leading to chronic inflammation in the gut wall.
MH002 consists of 6 well-characterized commensal strains that are optimized to form a synergistic micro-ecosystem driving differentiated potency, resiliency, and engraftment. Combining rational selection of disease-modifying strains with consortium optimization to ensure live delivery, engraftment, and durability is expected to result in greater efficacy than conventional microbiome therapeutics.
MRM Health’s Phase 2 study in pouchitis is a multi-center, open label trial which will enroll up to 20 acute pouchitis patients. The trial is designed to evaluate safety, mechanistic effects, and efficacy of MH002 on disease activity.
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