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.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Kirin Holdings will begin online sales of " Electric Salt Spoon ", a spoon that uses electricity to enhance salty and umami taste *1 , on May 2020.5.2024 03:30:00 CEST | Press release

Kirin Holdings Company, Limited (Kirin) will launch as a new business in the Health Science domain (Health Science business) a limited offering of 200 units of Electric Salt Spoon, which enhances the salty and umami taste of low-sodium foods with the power of electricity, on Monday, May 20, 2024 at its official online store (https://electricsalt.shop.kirin.co.jp/). In addition, a limited number of units will be available at Hands Inc. stores beginning in June. This tableware-type device is equipped with technology that enhances the salty taste perceived when eating low-sodium foods by approximately 1.5 times*2,3. The technology was developed through joint research with the Meiji University Dr. Homei Miyashita Laboratory of the Department of Frontier Media Science, School of Interdisciplinary Mathematical Sciences (Miyashita Laboratory). Through this device, we aim to realize a society in which people can improve their lifestyle in a delicious way. This press release features multimedia

Reality TV Star, Mollie Pearce, Backs Campaign to Tackle Inequalities in Condition That Impacts Millions of People Globally19.5.2024 00:01:00 CEST | Press release

Celltrion partners with TV star Mollie Pearce to launch the second installation of the Where’s Crohn’s & Colitis (CC)? campaign for this year’s World IBD Day (19 May 2024). The campaign focuses on access to IBD care and treatment as the burden of the condition rises globally1. Widening inequalities and significant variations in access across the globe, and even within countries, is impacting people’s experience of IBD care and ultimately their outcomes2. Through raising awareness of the factors driving these inequalities and potential solutions, the campaign hopes to encourage improved access to a timely diagnosis, high quality care and innovative treatments. Innovations in treatments, including advances in treatment administration that enable people to access at-home injectable treatment (versus hospital-based treatment), allows people to have an improved quality of life whilst managing their condition3. The campaign encourages people to look beyond what they would usually see, to mak

Unveiling the HPC Future with xFusion at ISC 202418.5.2024 05:37:00 CEST | Press release

xFusion Digital Technologies Co., Ltd. (xFusion) dazzled attendees with its top-of-the-range computing products and solutions at the prestigious ISC High Performance 2024 event, hosted at the Congress Center Hamburg in Germany from May 13th to 15th. During the event, xFusion and fellow participants delved into the realms of AI and high performance computing (HPC) to explore their innovative applications and developmental trends, marking a significant convergence of minds and technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240516487957/en/ (Photo: xFusion) Tab Tang , President of the Computing and Expansion at xFusion, delivered a keynote titled "Reinvent HPC in the Era of AI" during the Vendor Roadmap session on the 15th. He illuminated the pivotal role of smart computing in propelling industrial progress, highlighting the cooling challenges arising from high power and computing density, along with sustainabilit

Yard Force Introduces New 20V Cordless Lawn Mower: A Powerful, Efficient and Versatile Solution for Easy Lawn Care17.5.2024 17:19:00 CEST | Press release

Yard Force, a leading manufacturer of high-quality garden tools, is pleased to announce the launch of its latest product innovation, the Yard Force 20V Cordless Lawn Mower. Engineered for modern homeowners, this cutting-edge mower delivers power, efficiency and versatility for easy lawn care. Meet the new model: the LM C37B. The Yard Force LM C37B stands out with its 37 cm cutting width, for effortlessly tackling larger lawns. Capable of mowing up to 450 square metres, it's perfect for medium to large gardens, allowing homeowners to maintain a well-tended garden with minimal effort. Powered by a state-of-the-art brushless motor, the advanced technology of the LM C37B ensures exceptional performance and greater longevity, making it a dependable and durable addition to your garden tools. One of the standout features of the Yard Force LM C37B is its powerful 20V 2.5Ah dual battery system. This guarantees ample power to finish the job, regardless of lawn size. The package also includes a 2

Wipro Appoints Sanjeev Jain as Chief Operating Officer17.5.2024 14:52:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading technology services and consulting company, today announced the appointment of Sanjeev Jain as the Chief Operating Officer effective immediately. Sanjeev succeeds Amit Choudhary, who is stepping down to pursue opportunities outside the organization. Sanjeev will report to Srinivas Pallia and will continue to be a member of Wipro’s Executive Committee. Sanjeev joined Wipro in 2023 as the Global Head of Business Operations. He brings over 30 years of experience in leading large, diverse teams, scaling up global operations, and deploying Lean Six Sigma and design thinking principles to drive operational excellence and business transformation. Over the past year, Sanjeev has been leading Wipro’s talent supply chain, including Wipro’s gig work platform, TopGear, as well as talent skilling, global mobility, talent acquisition, and business resilience functions. He has played a key leadership role in the development and deployment

HiddenA line styled icon from Orion Icon Library.Eye