MRM Health to Share Positive MH002 Data in Ulcerative Colitis at DDW

MRM Health NV, a clinical-stage biopharmaceutical company based in Ghent, Belgium, is set to present promising findings for MH002, their leading live microbial consortium therapy for Inflammatory Bowel Diseases. The presentations will occur during the 2024 Digestive Disease Week® (DDW) meeting from May 18-21, 2024, in Washington, D.C.

The late breaker session, titled "IMIBD Late Breakers and Innovations in IBD," will feature a presentation on the safety and efficacy of MH002 for mild to moderate Ulcerative Colitis. This presentation is scheduled for Sunday, May 19, 2024, from 3:15 PM to 3:30 PM EDT, in Ballroom B. Dr. Séverine Vermeire, Principal Investigator and Scientific Advisor of MRM Health, will deliver the findings.

Another notable presentation is the "Poster of Distinction," under the session titled "Microbial Therapies for GI Disease," sponsored by the AGA. This session, showcasing MH002's mechanisms linked to restoring intestinal dysbiosis, mucosal integrity, and immune homeostasis, will take place on Monday, May 20, 2024, from 12:30 PM to 1:30 PM EDT. Dr. Sam Possemiers, CEO of MRM Health, will present the poster, which has been distinguished as being among the top 10% of AGA abstracts.

MH002's Phase 2a trial results in patients with mild-to-moderate Ulcerative Colitis revealed several key findings. The trial met its primary endpoint, showcasing excellent safety and tolerance at a fixed dose of 400mg per day over 16 weeks. Clinically relevant improvements were observed, including a 12% enhancement in the Mayo Endoscopic Severity (MES) score compared to a 5% worsening in the placebo group. Stool consistency in the MH002 treatment group improved significantly from week 2. By the end of the eight-week period, 18% of subjects achieved clinical remission, starkly contrasting with 0% in the placebo group. This trial, notably, did not require vancomycin preconditioning, unlike previous studies with other live biotherapeutics in Ulcerative Colitis.

Mechanistically, MH002 demonstrated a significant anti-inflammatory effect, indicated by a 42% reduction in median fecal calprotectin levels compared to an 18% reduction in the placebo group by week 8. The clinical effects paralleled microbiome restoration, and gene expression analysis showed downregulation of inflammation-related genes. These outcomes align with MH002's mode of action, which involves restoring intestinal dysbiosis, mucosal integrity, and immune homeostasis.

MH002 stands out as the most advanced rationally designed live microbial consortium therapy for Inflammatory Bowel Diseases, having shown safety and efficacy in Phase 2a trials for both Ulcerative Colitis and Pouchitis. Developed through MRM Health’s CORAL® Technology, MH002 consists of six well-characterized and safe commensal strains, optimized to target key disease mechanisms with enhanced potency, resiliency, and engraftment. The CORAL® Technology also supports scalable and standardized cGMP manufacturing, producing complete consortia as a single drug substance, providing regulatory and patient compliance advantages.

MRM Health, a clinical-stage biotech company, focuses on developing innovative therapeutics for inflammatory, CNS, and metabolic diseases. Their lead program, MH002, is preparing for pivotal clinical development in Ulcerative Colitis and Pouchitis. The company's proprietary CORAL® technology enables the design and optimization of microbiome-based biotherapeutics with faster onset-of-action and increased potency. Besides their Inflammatory Bowel Diseases program, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnerships for Type 2 Diabetes and NAFLD.

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