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:

M RM 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

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Venture Global Announces Commencement of Commercial Operations at Calcasieu Pass17.2.2025 23:07:00 EET | Press release

Today, Venture Global announced that it has notified its long-term customers that its Calcasieu Pass facility will commence commercial operations on April 15, 2025. The facility will achieve its commercial operation date, or COD, in under 68 months from its August 2019 final investment decision, despite substantial impacts including two hurricanes, the COVID-19 pandemic, and major unforeseen manufacturing issues, such as with the Heat Recovery Steam Generators (HRSGs) forming part of the facility’s power island. Venture Global wishes to express its gratitude to its construction and completion teams who tirelessly worked to safely complete our facilities, to our vendor teams who provided invaluable support for the necessary repairs, and to our government regulators, including the Federal Energy Regulatory Commission, for their oversight and cooperation. These efforts now allow us to supply our long-term customers with the full 20-year contract term of the lowest-cost, clean LNG as promi

Frontgrade Qualifies Industry’s First Class L GaN DC-DC Converter and EMI Filter17.2.2025 18:07:00 EET | Press release

Frontgrade Technologies, a leading provider of mission critical electronics for aerospace and defense, has become the first company to successfully qualify to Class L standards its Gallium Nitride (GaN)-based DC-DC converter and complementary electromagnetic interference (EMI) filter. Under the Defense Logistics Agency’s MIL-PRF-38534 specification, Class L qualification verifies these devices’ ability to meet the most stringent performance requirements of space missions from Low Earth Orbit (LEO) through Geostationary Earth Orbit (GEO). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250217986495/en/ Frontgrade Technologies has become the first company to successfully qualify to Class L standards its GaN-based DC-DC converter and complementary EMI filter. (Photo: Business Wire) Frontgrade’s new isolated, single-stage converters leverage advanced GaN FET technology to provide spacecraft designers with the industry’s most effi

Ruler of Ras Al Khaimah, UAE, Says ‘Science is the Bedrock Upon Which We Build a Sustainable Future’ During Opening Address at 16 th International Workshop on Advanced Materials17.2.2025 17:05:00 EET | Press release

His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, delivered an opening keynote address on the first day of the three-day International Workshop on Advanced Materials (IWAM), where he talked of science holding the key to building a more sustainable world and of how Ras Al Khaimah is committed to scientific advancement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250217844634/en/ His Highness Sheikh Saud bin Saqr Al Qasimi, UAE Supreme Council Member and Ruler of Ras Al Khaimah, delivering the opening keynote address at the International Workshop on Advanced Materials today (Photo: AETOSWire) HH Sheikh Saud said: “Through the annual hosting of IWAM, Ras Al Khaimah is reaffirming its commitment to nurturing scientific advancement and contributing to the global conversation on advanced materials. “By developing a culture of scientific enquiry and investing in advanced materia

Bentley Systems Issues Call for Nominations for the 2025 Going Digital Awards17.2.2025 16:01:00 EET | Press release

Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced nominations are now open for the 2025 Going Digital Awards. This renowned global program recognizes the very best digital advancements in infrastructure delivery and performance. Independent jurors—consisting of thought leaders and experts in their field—select the winners from among the world’s most extraordinary infrastructure projects. The deadline for nominations is March 31, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250217405555/en/ Winners of the 2024 Going Digital Awards celebrate their accomplishments. Nominations are now open for the 2025 awards. Image courtesy of Bentley Systems. Celebrating over 20 years, the awards program has recognized more than 5,250 of the world's most outstanding infrastructure projects. This global program is open to all Bentley software users and nominations are encourag

ICC Arbitral Tribunal Rules in Favor of AOP Health in Arbitration Proceedings Pertaining to BESREMi® (Ropeginterferon alfa-2b)17.2.2025 15:46:00 EET | Press release

Today, a tribunal under the auspices of the International Chamber of Commerce (ICC) served a partial final award in a dispute between PharmaEssentia Corp. (“PharmaEssentia”) and AOP Orphan Pharmaceuticals GmbH (“AOP Health”) in AOP Health’s favor. At the heart of the case were reciprocal claims for damages arising from a dispute regarding a licensing agreement between the parties. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250217280380/en/ Portrait: Dr. Rudolf Widmann | Member of the Board of Directors & Founder | AOP Health | Photocredit: AOP Health | Ospelt Photography The product in dispute The conflict centers around ropeginterferon alfa-2b, a substance launched in 2019 and that AOP Health has developed into an innovative treatment (BESREMi®) for rare blood cancers, particularly polycythemia vera, through a comprehensive clinical trial program. This makes BESREMi® the best investigated interferon in clinical trials i

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye