MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW)
15.5.2024 10:00:00 EEST | 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/
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
Strategic Partnership Between Record Asset Management and Admicasa2.7.2026 20:00:00 EEST | Press release
RAM Swiss Holding AG is a subsidiary of LSE-listed Record Financial Group (Record) and part of the Record Asset Management (RAM) group of companies. The partnership is a milestone in the growth of Admicasa and marks an important step in the continued expansion of Record’s private markets platform. Subject to regulatory approval, the agreement, signed on 1st July 2026, provides RAM Swiss Holding AG with a 50% participation in the Admicasa Fondsleitung AG, part of Admicasa, and establishes a long-term partnership to develop investment opportunities in the Swiss and Global real estate market with a plan to expand into other asset classes in the medium term. RAM is the European asset management arm of Record, the LSE-listed specialist investment group managing USD 115 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom it has built long-standing relationships th
IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange2.7.2026 17:47:00 EEST | Press release
IQM Quantum Computers (Nasdaq: IQMX) (“IQM”, “IQM Quantum Computers” or the “Company”), a global leader in full-stack superconducting quantum computers, today became a publicly traded company following the completion of its business combination with Real Asset Acquisition Corp. (“RAAQ”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702960460/en/ IQM Quantum Computers Becomes First European Quantum Computing Company Listed on a Major U.S. Exchange The company’s American Depositary Shares begin trading today on the Nasdaq Global Select Market under the ticker symbol “IQMX”. The listing marks a major milestone for IQM establishing the company as the first European quantum computing company listed on a major U.S. stock exchange. Due to the proceeds of the transaction, IQM maintains a strong pro forma cash position of EUR 337 million. IQM enters the public markets with strong commercial momentum and a rapidly expanding globa
GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio2.7.2026 17:00:00 EEST | Press release
GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, announced today the launch of its new GD24CL series I²C EEPROM. The series delivers outstanding performance, comprehensive security protection mechanisms, and excellent reliability that addresses the stringent requirements for stable and long-term storage of critical configuration data. These offered features will benefit applications in industrial, energy, Internet-of-Things (IoT), data centers, and networking. As GigaDevice’s first EEPROM product series, the launch further enhances the company’s non-volatile memory portfolio and provides customers with more dynamic storage solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260702394554/en/ GigaDevice Launches First GD24CL Series I²C EEPROM, Further Expanding Its Non-Volatile Memory Portfolio. The GD24CL series is designed with high
Medical University of Graz Enrolls First Patient in DEEPER CHALLENGE Trial Evaluating Spur ® Peripheral Retrievable Scaffold System in a Select CLTI Cohort2.7.2026 14:00:00 EEST | Press release
Reflow Medical, Inc. announces that the Medical University of Graz has enrolled the first patient in the DEEPER CHALLENGE clinical trial. This investigator-initiated, single-center, single-arm, prospective study, supported by a grant, investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701995624/en/ The study investigates early vessel recoil following below-the-knee treatment using the Spur® Peripheral Retrievable Scaffold System in combination with a commercially available drug-coated balloon. The study plans to enroll up to 40 patients with chronic limb-threatening ischemia (CLTI) across two distinct cohorts: patients with diabetes and patients with end-stage renal disease receiving hemodialysis for at least six months, with women comprisi
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)2.7.2026 13:30:00 EEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to eight newly hired non-executive employees. The equity awards were granted on July 1, 2026 and consisted of options to purchase an aggregate of 63,685 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 30,300 shares. The options have an exercise price per share equal to $13.29, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted sh
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