- Recent safety and efficacy data in both Ulcerative Colitis and Pouchitis continue to support MH002’s potential in indications characterized by mucosal damage and inflammation.
GHENT, Belgium -- (BUSINESS WIRE) --
MRM Health NV, a clinical-stage biopharmaceutical company developing innovative therapeutics for inflammatory, CNS and metabolic diseases, today announced it will present positive data for its lead asset, MH002, a live microbial consortium therapy for Inflammatory Bowel Diseases, in two oral presentations during the 2024 Digestive Disease Week® (DDW) meeting, being held May 18-21, 2024 in Washington, D.C. at the Walter E. Washington Convention Center.
Late Breaker Presentation Details
Session Title: IMIBD Late Breakers and Innovations in IBD
Presentation Title: Safety and Efficacy of MH002, an Optimized Live Biotherapeutic Product, for the Treatment of Mild to Moderate Ulcerative Colitis: A First-in-Disease, Double-Blind, Randomized Clinical Trial
Presenter: Séverine Vermeire, Ph.D., Principal Investigator and Scientific Advisor of MRM Health
Date and Time: Sunday, May 19, 2024, 3:15 PM – 3:30 PM EDT
Location: Ballroom B
Poster of Distinction Presentation Details
Session Title: Microbial Therapies for GI Disease
Session Sponsor: AGA
Presentation Title: MH002, an Optimized Live Biotherapeutic Product for the Treatment of Inflammatory Bowel Diseases, Has Mode-of-Actions Linked to Restoration of Intestinal Dysbiosis, Mucosal Integrity, and Immune Homeostasis
Poster Number: Mo1919
Presenter: Sam Possemiers, Ph.D., Chief Executive Officer of MRM Health
Date and Time: Monday, May 20, 2024, 12:30 PM – 1:30 PM EDT
This poster has been selected by DDW as a “Poster of Distinction,” recognizing the top 10% of all AGA abstracts selected for poster presentation.
Key findings that will be presented include:
- The primary endpoint from a placebo-controlled Phase 2a trial in mild-to-moderate Ulcerative Colitis patients was met, with an excellent safety profile and tolerance at a fixed dose of 400mg per day over 16 weeks administration.
- Initial efficacy on disease activity was evidenced in clinically relevant parameters, including a 12% improvement in Mayo Endoscopic Severity (MES) score (p=0.05, 1-sided Wilcoxon rank sum test), while placebo worsened by 5%. Stool consistency significantly improved in the MH002 treatment group as from week 2 (p=0.006; 1-sided Student t-test). At the end of the eight-week period, 18% of subjects achieved clinical remission compared to 0% of the placebo group (Per-protocol analysis). In contrast to previous trials with other live biotherapeutics in UC, this study was performed successfully without vancomycin preconditioning.
- At a mechanistic level, anti-inflammatory effect was demonstrated with a 42% decrease in median fecal calprotectin (a clinically relevant bowel inflammation marker) compared to 18% in placebo at week 8. Furthermore, microbiome restoration occurred in parallel with clinical effects, and differential gene expression analysis showed downregulation of genes involved in inflammation. These findings were in line with the mode-of-action of MH002 and linked to restoration of intestinal dysbiosis, mucosal integrity, and immune homeostasis.
-Ends-
About MH002
MH002 is currently the most advanced rationally designed live microbial consortium therapy in Inflammatory Bowel Diseases, having demonstrated safety and efficacy in phase 2a trials in both Ulcerative Colitis and Pouchitis. It was developed through MRM Health’s proprietary CORAL® Technology and comprises six well-characterized and safe commensal strains, selected and optimized to tackle key disease-driving mechanisms with enhanced potency, resiliency, and engraftment. MRM Health’s breakthrough scalable and standardized cGMP manufacturing platform allows for the manufacturing of complete consortia as a single drug substance. This ability of CORAL® to enable scalable, cost-effective manufacturing of complete optimized consortia in a single process is expected to provide both key regulatory and patient compliance advantages.
About MRM Health
MRM Health is a clinical-stage biotech developing innovative therapeutics for inflammatory, CNS and metabolic diseases. The Company’s most advanced program MH002 is in preparation for pivotal clinical development in Ulcerative Colitis and/or in the orphan disease indication Pouchitis. MRM Health leverages its proprietary disruptive CORAL® technology platform to design microbiome-based biotherapeutics, based on disease-focused specific combinations of 5 to 10 live gut bacteria, and to optimize them for faster onset-of-action and increased potency and robustness. A significant differentiator is the ability to manufacture these consortia as single drug substance in a single standardized, scalable and highly cost-effective process. In addition to the program in Inflammatory Bowel Diseases, MRM Health has ongoing preclinical programs in Parkinson’s Disease and Spondyloarthritis, and partnered programs with IFF in Type 2 Diabetes and NAFLD.