MRM Health to Present Positive Clinical Data from MH002 in Ulcerative Colitis at Digestive Disease Week (DDW)
May 15 2024 - 3:00AM
Business Wire
- Recent safety and efficacy data in both Ulcerative Colitis and
Pouchitis continue to support MH002’s potential in indications
characterized by mucosal damage and inflammation.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240515115683/en/
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