MRM-HEALTH
15.5.2024 09:01:30 CEST | Business Wire | Press release
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.
For more information, please visit the website at www.mrmhealth.com.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240515115683/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
IAS Launches IAS Total TV Solutions Giving Marketers ‘Linear-like’ Transparency for Connected TV27.4.2026 14:30:00 CEST | Press release
‘IAS Total TV’ unlocks show, genre and rating transparency measurement across Disney, NBCUniversal, Paramount and Prime Video, plus multiple opted-in publishers using Publica enabling advertisers to enhance brand suitability while increasing campaign outcomes Integral Ad Science (IAS) today announced ‘IAS Total TV’, a new comprehensive suite of Connected TV (CTV) solutions designed specifically to bring ‘linear-like’ transparency to streaming TV. IAS Total TV can provide marketers with genre, rating, language, show and program-level data in aggregate from Disney, NBCUniversal, Paramount and Prime Video, in addition to multiple opted-in publishers using Publica. IAS Total TV integrates content insights, media quality, supply path and outcomes into a unified view within the IAS Signal user interface (UI). Advertisers can determine when and how they want their advertising to run alongside CTV content, ensuring brand-related and brand suitable environments. “As advertisers continue to doub
Riskified Study Finds Consumers Aren’t Ready to Hand Over Control as AI Transforms Shopping, with Over Half Afraid of Online Fraud27.4.2026 14:00:00 CEST | Press release
New Q1 2026 “Agentic Commerce Pulse” survey from Riskified reveals a growing trust gap in agent-driven commerce, as consumers embrace AI across the shopping journey but remain hesitant to hand over control amid concerns over fraud, security, and accountability Riskified (NYSE: RSKD), a global leader in ecommerce fraud and risk intelligence, today released the Q1 2026 edition of its Agentic Commerce Pulse, a quarterly research series tracking agentic commerce risks and consumer engagement. Following Riskified’s inaugural Q4 2025 survey, which first highlighted the rapid emergence of agent-driven commerce, the latest findings reveal a more complex reality: while AI adoption remains strong, consumer trust is not keeping pace. A widening gap is emerging between how shoppers use AI and how much control they are willing to give it. The survey, conducted among consumers across the United States and the United Kingdom, shows that AI is now firmly embedded in product discovery and decision-maki
Nine in 10 Expect Cross-Border M&A Surge, But 71% of Dealmakers Have Already Changed Course on Deals27.4.2026 14:00:00 CEST | Press release
90% of dealmakers expect cross-border M&A activity to increase over the next 12–24 months75% cite foreign direct investment screening as the biggest threat to deal completion88% report longer signing-to-close timelines than three years ago Cross-border M&A is set for a strong resurgence, with nine in 10 senior dealmakers expecting activity to increase over the next 12 to 24 months, according to new research from CSC, the leading provider of business administration and compliance solutions. However, despite this renewed momentum, execution risk is rising, with regulatory scrutiny and operational challenges making it harder to get deals over the line. CSC¹ surveyed 200 director level and above global dealmakers across private equity, corporate, legal, and advisory roles who have worked on cross-border transactions in the past two years. The report, The New Reality of Cross-Border M&A: More Deals, More Friction, explores how firms are navigating an increasingly complex global deal environ
Mundipharma announces positive topline results from Phase III ReSPECT trial assessing ▼REZZAYO® (rezafungin) for the prophylaxis of invasive fungal diseases in allogeneic haematopoietic stem cell transplantation patients27.4.2026 13:43:00 CEST | Press release
For Trade and Medical Media Only The study primary endpoint was met, showing non-inferiority vs. standard antimicrobial regimen in fungal-free survival at Day 90 Study showed favourable benefit for toxicity-related discontinuations and drug-drug interactions (DDIs) Rezafungin was well tolerated, with a safety profile comparable to standard antimicrobial regimens (SARs) Mundipharma today announced positive Phase III topline results from the global ReSPECT clinical trial evaluating REZZAYO® (rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (HSCT). The ReSPECT Phase III trial, one of the largest antifungal, multicentre, randomised, double-blind studies evaluated the efficacy and safety of once weekly rezafungin compared with a SAR for the prophylaxis of IFDs, including infections caused by Candida, Aspergillus, and Pneumocystis, in adults undergoing allogeneic HSCT. Patients undergoing a
vVARDIS Announces Investment from Apollo—Achieves Unicorn Status27.4.2026 13:00:00 CEST | Press release
Investment will support global commercial expansion of the Curodont™ technology platform, the first and only non-invasive peptide-containing formulations designed to treat tooth decay drill-free throughout the depth of the lesion vVARDIS Holding AG (“vVARDIS”), a high-growth dental medtech company pioneering non-invasive cavity treatment, today announced a strategic minority investment from Apollo-managed funds (“Apollo Funds”). The investment will support vVARDIS’ next phase of global growth and commercial expansion, including the continued rollout of its Curodont™ suite of products. The investment establishes vVARDIS as one of Europe’s few privately owned, billion-dollar-plus, healthcare companies. vVARDIS’ founders and co-CEOs, Drs. Haley and Goly Abivardi, will retain a substantial majority shareholding in the company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260415938477/en/ Photo credit: Jos Schmid, Photographer
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom