Business Wire

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

Share

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.

Contact information

For further information please contact:

MRM Health
Dr Sam Possemiers – CEO
Christiane Verhaegen – CFO
Tel: +32.9.277.08.50
info@mrmhealth.com

Stern Investor Relations
Stephanie Ascher
Stephanie.ascher@sternir.com
+1 212-362-1200

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.com

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

Rapid Medical™ Completes Initial Neurovascular Cases in the USA Following FDA Clearance of Its Active Access Solution22.7.2024 16:16:00 CEST | Press release

Rapid Medical™, a leading developer of advanced endovascular devices, announces the first procedures in the USA with the breakthrough deflectable access platform DRIVEWIRE 24 at the 2024 Society of NeuroInterventional Surgery’s (SNIS) 21st Annual Meeting. With active technology, DRIVEWIRE articulates a wide range of catheters for direct access to endovascular locations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240722355520/en/ DRIVEWIRE 24 redefines interventional access by providing an active deflectable tip that controls and steers a range of catheters directly to the target vessels. Whereas conventional access devices are reactive and rely on external forces to reach their target, DRIVEWIRE's active technology selects turns on-demand and handles the complexity of navigating the vascular highway with ease. (Graphic: Business Wire) “DRIVEWIRE addresses a major unmet need in the endovascular space,” exclaims Dr. Shahra

Cessna Caravan Flight Deck to Feature Cockpit Advancements, Enhancing Flight Experience for Pilots22.7.2024 15:00:00 CEST | Press release

Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced significant enhancements to its legendary Cessna Caravan and Cessna Grand Caravan EX utility turboprop aircraft. A brighter, modernized flight deck with new backlit panels, along with other amenities designed to elevate the pilot experience, are the direct result of continuous conversations with customers. The enhancements, which are expected to be available in 2025, will be standard on all new Caravan and Grand Caravan EX aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240722286058/en/ Textron Aviation | Cessna Grand Caravan EX & Cessna Caravan (Photo: Business Wire) “The enhancements to the Cessna Caravan flight deck demonstrate our continued commitment to providing the best possible flight experience for our customers,” said Christopher Crow, vice president, Piston and Utility Sales. “Our ongoing investments in this family of aircraft cont

i2c Inc. Announces Strategic Partnership with Beyon Money Business to Launch Corporate Card Program22.7.2024 15:00:00 CEST | Press release

i2c Inc., a leading provider of digital banking and payments solutions, today announced that it is partnering with Beyon Money Business, a new vertical offering digital financial solutions for SMEs and Corporates, to launch an advanced corporate expense card program tailored to the small to mid-size enterprise sectors. The program will be available in Bahrain initially and throughout the states of the Gulf Cooperation Council (GCC) in the future. Leveraging i2c’s modular building block SaaS technology, the Beyon Money Business program underscores its commitment to flexible financial products and to modernizing how corporates manage their expenses through enhanced functionality and security features, such as 3D security for e-commerce transactions. The launch of Beyon Money Business directly responds to the growing need for specialized corporate financial tools. With i2c's flexible banking and payments platform enabling the development of a state-of-the-art expense management solution,

Xsolla Expands Support for Game Developers Through the Greater China Region Launch, Marking a New Era in the Gaming Industry22.7.2024 14:00:00 CEST | Press release

Xsolla, a global video game commerce company known for its extensive suite of tools and services specifically designed for the game industry, is thrilled to announce the grand opening of the Xsolla Greater China Region office. The opening event will occur on Monday, July 22, 2024, at D-06 Parkview Green Fangcaodi, Chaoyang District, signifying a renewed commitment to enhancing and growing the video game industry in China and worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240722568214/en/ (Graphic: Xsolla) The expansion of the Xsolla Beijing office embodies a vision to serve as a humble partner and provide access to the tools and services for everyone in the gaming community, assisting companies with ambitions to navigate and reach emerging markets swiftly. This expansion is not just a physical establishment; it is the center of China's technology and gaming community. Under the theme "Equal Access for Everyone," t

TOM FORD Announces the Departure of Creative Director Peter Hawkings22.7.2024 14:00:00 CEST | Press release

TOM FORD announced today that Peter Hawkings is stepping down as Creative Director of the brand. Peter Hawkings has been at TOM FORD since its inception and at the helm of creative since April 2023. “I would like to express my gratitude to Peter for his exceptional contributions to TOM FORD from the very beginning,” said Guillaume Jesel, President and CEO, TOM FORD and Luxury Business Development, The Estée Lauder Companies. "I want to thank Peter for his collaboration since TOM FORD FASHION became part of the Ermenegildo Zegna Group. Along with his team, Peter has contributed to this important initial phase of development. I wish him all the best in his next chapter,” said Lelio Gavazza, CEO of TOM FORD FASHION. The Spring-Summer 2025 collection will be presented in the Milan showroom in September 2024. A successor will be announced in the near future. About TOM FORD TOM FORD IS A GLOBAL DESIGN HOUSE OFFERING EXCEPTIONAL LUXURY WOMEN’S AND MEN’S FASHION, ACCESSORIES, EYEWEAR AND BEAUT

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
HiddenA line styled icon from Orion Icon Library.Eye