Metabolic

MRM Health announces that the first patient with Next. is treated

GENT, Belgium, Dec 08, 2021 (GLOBE NEWSWIRE) – MRM Health, a clinical-stage biopharmaceutical company developing next-generation living microbiome consortium therapeutics, announced the first patient to receive MH002 in a multicenter Phase 1b / 2a clinical trial in mild to moderate ulcerative colitis. MH002 is MRM Health’s first clinical product candidate to emerge from its proprietary and unique CORAL ™ platform technology.

“We are very excited about this next step in the development of MH002 in ulcerative colitis,” said Sam Possemiers, Ph.D., chief executive officer of MRM Health. “Treating the first patient in this study is a great achievement for our team, a milestone for the company and an important step in improving the lives of patients with ulcerative colitis (UC). We would like to thank our Belgian and international investigators for their commitment to the successful development of our first clinical program that emerged from the CORAL ™ platform. “

MRM Health’s MH002-UC-201 study is a multicenter, double-blind, randomized, placebo-controlled study in multiple clinical sites in Belgium, Poland and the Czech Republic that will enroll 45 patients with mild to moderate UC. The study will evaluate the safety, mechanistic effects and the initial efficacy of MH002 on disease activity. Further information on the study can be found at Clinicaltrialsregister.eu with the identifier 2020-004355-33.

“My medical team is very motivated to investigate this promising novel treatment in our patients,” said investigator Prof. Pieter Dewint, (MD, PhD), gastroenterologist at AZ Maria Middelares, Ghent, Belgium. “The potential to provide effective treatment for our patients who pose no serious or serious risks would represent real advancement in their wellbeing.”

“There is a great unmet medical need for an effective and safe new drug to treat mild to moderate UC,” said Prof. Séverine Vermeire (MD, PhD), IBD expert at the Department of Gastroenterology at Leuven University Hospital. Belgium and lead investigator in the process. “MH002 has all the features and the potential to meet this need and could become a novel tool in the first-line treatment of UC.”

MH002 is the first candidate product to emerge from MRM Heath’s CORAL ™ platform, where key disease-promoting mechanisms control the selection of therapeutic microbial strains for entry into clinical trials in patients. Preclinical studies of inflammatory bowel disease (IBD) models showed that MH002 repairs gut microbiome dysbiosis, heals the dysfunctional gut barrier, and restores immune homeostasis with its differentiated mechanism that targets several major disease pathways. MH002 has demonstrated excellent safety and superior preclinical efficacy compared to traditional, non-optimized microbiome therapeutics, as well as mesalamine, the current standard of first-line treatment in UC.

As part of the CORAL ™ platform, MH002 is manufactured by a breakthrough, scalable, robust, and standardized cGMP manufacturing technology that overcomes the challenges of the microbiome in creating consortia with multiple strains of uniform composition. CORAL ™ enables the creation of full consortia as a single drug substance that is expected to provide important regulatory as well as patient compliance benefits.

About MRM health

MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on developing optimized, next-generation consortium therapeutics based on the human microbiome. With its proprietary CORAL ™ platform, the company has built a diversified pipeline to develop, optimize and manufacture bacterial consortia as a single drug substance. Its most advanced program, MH002, is an optimized consortium of 6 rationally selected and well-characterized commensal tribes. MH002 will enter a phase 1b / 2a study in patients with mild to moderate ulcerative colitis in the fourth quarter of 2021. Further pipeline development includes a preclinical program for Parkinson’s disease and two preclinical programs for metabolic diseases (partnership with IFF Nutrition Biosciences, formerly DuPont). , and a discovery program in autoimmune diseases, including spondyloarthritis.

About CORAL ™

The differentiating CORAL ™ platform from MRM Health uses a bioinformatics-driven in-human discovery machine combined with a breakthrough in the optimization and manufacture of consortia as a single drug substance. The proprietary consortium optimization technology enables the development of next-generation consortium therapeutics with faster onset of action and increased effectiveness and robustness. The groundbreaking, scalable, robust and standardized cGMP-compliant consortium manufacturing technology enables the manufacture of complete therapeutic consortia as a single drug substance in a single manufacturing process that significantly outperforms existing approaches in speed, reduced complexity, increased robustness and lower costs.

About CED and UC

Ulcerative colitis (UC) is a chronic, autoimmune, inflammatory bowel disease (IBD) characterized by inflammation of the lining of the rectum and colon, causing debilitating diarrhea, abdominal pain, and rectal bleeding. Current treatments include symptomatic anti-inflammatory therapies and immunosuppressants. In many cases, these therapies cannot induce permanent remission and / or cause potentially serious side effects.

There remains a significant unmet clinical need in UC as many patients remain refractory to standard treatment and current treatments (e.g., anti-inflammatory, immunosuppressive approaches) primarily provide symptomatic relief. The disease modifying mechanism of MH002 is expected to induce remission through immunomodulation rather than immunosuppression, resulting in superior safety without increased risks associated with decreased immune system function.

For more information please contact:

Dr. Sam Possemiers – CEO
Christiane Verhaegen – CFO
Telephone: +32.9.241.11.88
[email protected]

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