drugset / Press release

MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW)

2024-05-15 · MRM Health NV · original mrmhealth.com ↗

MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW) - 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, May 15, 2024 – 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 M H002, 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 p lacebo 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, PRESS RELEASE MRM Health NV www.mrmhealth.com Technologiepark 82 +32.9.277.08.50 [email protected] 9052 Ghent, Belgium 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 faste r onset -of-action and increased potency and robustness . A significant differentiator is the ability to manufacture the se 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. For more information, please visit the website at www.mrmhealth.com. For further information please contact: MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen – CFO Tel: +32.9.277.08.50 [email protected] Stern Investor Relations Stephanie Ascher [email protected] +1 212-362-1200

The release as fetched from its publisher. mrmhealth.com ↗