MRM-HEALTH
28.6.2022 11:25:08 CEST | Business Wire | Press release
MRM Health, a clinical-stage biopharmaceutical company developing next-generation live microbiome consortia therapeutics, announced today that they have received regulatory approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium to start a Phase 2 trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis.
MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis. Pouchitis (inflammation of the surgically constructed pouch after colectomy) 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). Pouchitis occurs in up to 50% of these patients within 1-2 years after surgery. 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. To date, no registered oral therapeutics are available for Pouchitis, resulting in a significant unmet need for patients suffering from this highly debilitating, yet understudied rare disease indication.
Developed through MRM Health’s proprietary CORAL® Technology, MH002 consists of 6 well-characterized commensal strains that are optimized to form a synergistic microecosystem driving differentiated potency, resiliency, and engraftment. Combining rational selection of disease-modifying strains with consortium optimization to ensure live delivery, engraftment, and durability is expected to result in greater efficacy than conventional microbiome therapeutics. MH002 is produced using MRM Health’s breakthrough scalable, robust, and standardized cGMP manufacturing platform, overcoming past microbiome challenges in manufacturing multi-strain consortia of uniform composition. The standardized CORAL® platform allows the manufacturing of complete consortia as a single drug substance, expected to provide both key regulatory and patient compliance advantages.
Preclinical studies in inflammatory bowel disease (IBD) models showed that MH002 has an excellent safety profile, repairs gut microbiome dysbiosis, heals the dysfunctional intestinal barrier, and restores immune homeostasis with its differentiated mechanism targeting multiple key disease pathways. MH002 is currently assessed in a Phase 1b/2a study in patients with mild-to-moderate UC. The product’s disease-modifying mechanism is anticipated to induce remission in IBD via immunomodulation, rather than immunosuppression, resulting in superior safety with no elevated risks associated with reduced immune system functioning.
MRM Health’s Phase 2 study in Pouchitis is a multi-center, open label trial which will enrol up to 20 acute Pouchitis patients. The trial is designed to evaluate safety, mechanistic effects, and efficacy of MH002 on disease activity (EUDRACT Number: 2021-006656-14).
“With no registered oral treatment available for Pouchitis, a strong medical need exists for an effective and safe new medicinal product for the treatment of this serious disease. With its differentiating mode-of-action, MH002 has a high potential to fill that need and may become a novel tool in the first-line treatment of Pouchitis,” said Prof. Séverine Vermeire (MD, PhD), IBD expert at the Gastroenterology Department of the University Hospitals Leuven, Belgium, and coordinating investigator of the trial.
“This approval is another major step forward for MRM Health, as it allows to initiate a second clinical program and to further develop our rationally designed bacterial consortia therapeutic MH002 towards patients with IBD and beyond,” said Sam Possemiers (PhD), CEO and Co-Founder of MRM Health.
About MRM Health
MRM Health NV, Ghent, Belgium, is a biopharmaceutical company focused on the development of next-generation optimized consortium therapeutics based on the human microbiome. The company has built a diversified pipeline with its proprietary CORAL® platform to design, optimize, and manufacture bacterial consortia as single drug substance. Its most advanced program MH002 is an optimized consortium of 6 rationally-selected and well-characterized commensal strains. MH002 is currently being studied in two Phase 1b/2a studies in patients with mild-to-moderate Ulcerative Colitis and acute Pouchitis, respectively. Additional pipeline development includes a preclinical program in Parkinson’s disease, preclinical programs in Type 2 Diabetes and in NAFLD (both partnered with IFF Nutrition Biosciences, previously DuPont), and a discovery program in autoimmune disease, including spondyloarthritis.
About CORAL®
MRM Health’s differentiating CORAL® platform utilizes a bioinformatics-guided in-human discovery engine combined with a breakthrough in optimization and manufacturing of consortia as single drug substance. The proprietary consortia optimization technology allows to develop next-generation consortia therapeutics with faster onset-of-action and increased potency and robustness. The breakthrough scalable, robust, and standardized cGMP-compliant consortia manufacturing technology allows to manufacture complete therapeutic consortia as a single drug substance in a single manufacturing process which strongly surpasses existing approaches in speed, reduced complexity, increased robustness and lower cost.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220628005573/en/
Link:
About Business Wire
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
VahatiCor Appoints Harry D. Rowland, Ph.D., as Chief Executive Officer18.5.2026 08:00:00 CEST | Press release
Endotronix co-founder and former CEO joins VahatiCor as the company advances the A-FLUX Reducer System® and the SERRA-I early feasibility study VahatiCor, Inc., a medtech company developing interventional therapies for Coronary Microvascular Dysfunction (CMD), announced today the appointment of Harry D. Rowland, Ph.D., as Chief Executive Officer. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517830314/en/ VahatiCor CEO, Harry D. Rowland, Ph.D. Rowland previously served as Chief Executive Officer and President of Endotronix, where he led the development and commercialization of the Cordella™ Pulmonary Artery Sensor and Heart Failure System. Under his leadership, Endotronix raised over $150 million and grew to more than 150 employees. He also oversaw the PROACTIVE-HF pivotal trial from execution through FDA premarket approval and commercial launch. Following its acquisition by Edwards Lifesciences in 2024, Rowland stayed o
Modon Partners With Montage Hotels & Resorts to Bring Ultra-Luxury Hospitality Brand to Egypt’s Ras El Hekma17.5.2026 13:53:00 CEST | Press release
Montage Ras El Hekma introduces the first branded residences for purchase at the Mediterranean destination, alongside the region’s first Montage resort Abu Dhabi-based Modon Holding and Montage Hotels & Resorts have announced Montage Ras El Hekma, which will introduce the first branded residences for purchase at Ras El Hekma on Egypt’s Mediterranean coast. This is the first Montage resort in Egypt – supporting the emerging city’s growth as a global hub for leisure, business and tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260517167234/en/ Modon partners with Montage Hotels & Resorts to bring ultra-luxury hospitality brand to Egypt’s Ras El Hekma (Photo: AETOSWire) Montage Ras El Hekma will feature 200 guestrooms and suites, in addition to 96 Montage Residences, and will offer a curated mix of wellness and leisure amenities, including beachfront swimmable lagoons, a Spa Montage with 13 treatment rooms, and six dini
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale Selects MEVION S250-FIT™ for Southern Italy’s First Proton Therapy Center17.5.2026 08:00:00 CEST | Press release
Compact, vault-integrated platform selected through a competitive European tender will bring proton therapy to patients across Southern Italy. Mevion Medical Systems, the global leader in compact proton therapy, today announced that it has been selected to deliver the MEVION S250-FIT Proton Therapy System™ to Istituto Nazionale Tumori IRCCS Fondazione G. Pascale in Naples. The award, made following a competitive European tender, will establish the first proton therapy center in Southern Italy, significantly expanding access to advanced radiation therapy for patients across the region and reducing the need for patients to travel long distances to northern Italy for care. Until now, proton therapy in Italy has only been available at centers located in Northern Italy, requiring patients from Southern Italy to travel significant distances for care. The Pascale project supports a broader strategy to establish Naples as a leading oncology hub and to improve healthcare equity across Italy. “T
TetraMem Announces 22nm Multi-Level RRAM Analog In-Memory Computing SoC Milestone16.5.2026 10:43:00 CEST | Press release
TetraMem Inc., a Silicon Valley–based semiconductor company developing analog in-memory computing (IMC) solutions, today announced the successful tape-out, manufacturing, and initial silicon validation of its MLX200 platform, a 22nm multi-level RRAM-based analog IMC system-on-chip (SoC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260516556464/en/ Photograph of the MLX200 chip with a five-cent coin for size reference The achievement marks a significant step toward the commercialization of analog computing architectures based on emerging non-volatile memory technologies, addressing the growing challenges of data movement, power consumption, and thermal constraints in modern AI systems. As AI workloads continue to scale, system performance is increasingly constrained by the cost of moving data between memory and compute units. Analog in-memory computing offers a fundamentally different approach by performing computation dir
STARTEEPO Invest Announces 5% Stake in Xerox Holdings Corporation15.5.2026 18:15:00 CEST | Press release
STARTEEPO Invest (“STARTEEPO”), an alternative investment fund focused on public equity opportunities, today announced that it has acquired a significant ownership position in Xerox Holdings Corporation (“Xerox” or the “Company”). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260515594020/en/ As of the date of this release, STARTEEPO and its affiliates beneficially owns 6.6 million shares of Xerox (excluding options), representing approximately 5.05% of the Company’s outstanding common stock. STARTEEPO has filed a Schedule 13D with the U.S. Securities and Exchange Commission (the “SEC”) providing additional details regarding its investment. Investment Perspective STARTEEPO believes that Xerox represents an interesting investment opportunity supported by a combination of balance sheet initiatives, ongoing operational improvements, and its position within a changing and consolidating industry. In STARTEEPO’s view, the Company
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