MRM Health Reports Safety and Positive Efficacy Data in Pouchitis in Phase 2a Clinical Study with MH002
April 16 2024 - 3:00AM
Business Wire
- Met primary endpoint of safety: MH002 was safe and well
tolerated with no evidence of adverse reactions when administered
for 8 weeks.
- Clinical remission rate of 46% at week 8, a mean decrease in
the modified Pouchitis Disease Activity Index (mPDAI) symptom score
of 42% and a concomitant mucosal healing and reduction of mucosal
inflammation.
- Following recent positive results obtained with MH002 in
Ulcerative Colitis, consistent treatment effects observed with
MH002 in Pouchitis further underscore its potential in indications
characterized by mucosal damage and inflammation.
- Initiation of Phase 2/3 development enabled based on recent
positive regulatory feedback.
- MH002 is currently the most advanced rationally-designed
microbiome consortium therapy in the field of Inflammatory Bowel
Disorders (IBD).
MRM Health NV, a clinical-stage biopharmaceutical company
developing innovative therapeutics for inflammatory, CNS and
metabolic diseases, today reports positive topline results from its
Phase 2a clinical trial with MH002 in the orphan disease indication
Pouchitis.
MRM Health’s MH002-PC-201 study was a multi-center, open-label
clinical trial in 14 acute Pouchitis (PC) patients at multiple
clinical sites in Belgium and Italy. The study was designed to
evaluate safety (primary objective), initial efficacy, and
mechanistic effects of MH002 over 8 weeks. More information about
the trial is available at clinicaltrialsregister.eu.
The trial met its primary objective with an excellent safety and
tolerability at a fixed dose of 400mg per day over 8 weeks’
administration. Treatment-Emergent Adverse Events (TEAE) reported
were predominantly mild and unrelated, and there was no evidence of
adverse reactions related to MH002.
It also demonstrated initial efficacy in clinically relevant
parameters, including a 46% clinical remission rate after 8 weeks
of treatment (based on the definition used Travis et al., NEJM 2023
and using investigators’ assessments), and a decrease in modified
Pouchitis Disease Activity Index (mPDAI) cumulative symptoms score
of 42%. Clinical remission coincided with improvement of fecal
urgency, normalization of stool frequency, mucosal healing (mPDAI
endoscopic score, PDAI histology score and reduced ulceration) and
reduction of mucosal inflammation (fecal calprotectin).
“These new clinical results further enhance the positive
clinical data previously reported with MH002 in the treatment of
Ulcerative Colitis (UC), indicating that MH002 was safe and well
tolerated by patients with active gut inflammation and that it
demonstrates potential efficacy in acute Pouchitis,” commented
Séverine Vermeire, coordinating investigator of study MH002-UC-201
and Professor of Medicine at the KU Leuven, Belgium. “For both
Pouchitis and UC there is a significant unmet medical need for
treatments modulating the gut microbiome, and I look forward to
MH002 progressing to late-stage clinical development in view of
making it available to patients as soon as possible.”
Bruce Sands, Professor of Medicine at the Icahn School of
Medicine at Mount Sinai, New York, and paid consultant to MRM
Health added: “The consistency in clinical endpoints
improved by MH002 in two clinical studies with different patient
populations highlights the potential of MH002’s mechanism of
action, and its combined effect on mucosal healing and reduction of
inflammation is promising, along with a very favorable benefit/risk
balance, pending larger confirmatory studies.”
Based on the combined results from both clinical trials and
recent positive feedback from regulatory authorities, the Company
is in the position to initiate Phase 2/3 development in Ulcerative
Colitis, to be combined with further development in Pouchitis.
MH002 is currently the most advanced rationally designed live
microbial consortium therapy in Inflammatory Bowel Diseases. 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.
Sam Possemiers, Chief Executive Officer at MRM Health,
said: “These new clinical data further validate our proprietary
CORAL® technology and reinforce the potential of MH002 as a novel
and differentiated therapy for the treatment of diseases
characterized by mucosal impairment and inflammation, both within
IBD and beyond. These data enable us to advance to pivotal clinical
development with MH002 later this year, and we are engaging with
regulatory agencies in the US and EU to outline an accelerated
Phase 2/3 development strategy.”
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.
About Pouchitis
Pouchitis (PC), an orphan disease indication within the
Inflammatory Bowel Diseases (IBD), is the most prominent
complication after surgical removal of the large bowel (colectomy)
that is performed as a last resort treatment in Ulcerative Colitis
(UC). PC is characterized by inflammation of the surgically
constructed pouch after colectomy. Today, still 10 to 15% of all UC
patients, having severe and/or treatment resistant disease,
eventually require colectomy and pouch surgery. While temporarily
improving their condition, PC however occurs in up to 50% of these
patients within 1-2 years after surgery. Symptoms much resemble
those of the UC they suffered from initially, i.e. debilitating
diarrhea, abdominal pain, urgency, and rectal bleeding with
significant impact on quality of life. Disease mechanisms include
impaired gut wall barrier function linked to gut microbiome
dysbiosis, translocation of microbial products and resulting immune
cell activation, leading to chronic inflammation in the gut wall.
Current treatment consists of antibiotics and in non-responders
(when chronic and antibiotic resistant), mesalamine, corticosteroid
or biological treatment may be prescribed. MH002 is designed to
enrich the gut microbiome of UC patients and thereby tackle key
disease-driving mechanisms considered root cause of the
disease.
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MRM Health Dr Sam Possemiers – CEO Christiane Verhaegen –
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