Belgian biotechnology company MRM Health has reported positive topline data from the Phase IIa MH002-UC-201 clinical trial of MH002 for the treatment of mild-to-moderate ulcerative colitis (UC).
The placebo-controlled, double-blind study was carried out at several sites across Poland, the Czech Republic and Belgium.
It assessed the safety, initial efficacy and mechanistic effects of the microbiome consortium therapy MH002 in UC patients.
A total of 45 patients were enrolled to receive MH002 or placebo for eight weeks. They were also included in a subsequent eight-week extension period.
The study met its primary endpoints of safety and tolerance at a fixed dose of 400mg MH002 taken daily over 16 weeks.
Initial efficacy was also observed in clinically relevant parameters, including a 17% improvement over placebo at week eight in Mayo Endoscopic Severity score.
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No evidence of adverse reactions was found related to MH002 and stool consistency improved in the MH002 treatment group from week two.
At week eight, an anti-inflammatory effect was demonstrated with a 42% decrease in median faecal calprotectin, compared with an 18% decrease in the placebo cohort.
MRM Health CEO Sam Possemiers said: “These early clinical data are very important for the company since they further validate our proprietary CORAL technology which underlies our portfolio of live biotherapeutic products.
“The data enables us to take the next steps in our business strategy where we will be engaging with regulatory agencies in all territories and potential new partners, as well as driving forward the rest of our development portfolio.”
Full analysis data from the trial are expected by the end of this year. MRM Health also plans to advance the study to Phase II/III development.
Based in Ghent, MRM Health works to develop novel therapeutics for inflammatory, CNS and metabolic diseases.
MH002 is currently the company’s most advanced clinical programme.