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
Ant Group Unveils Ling-3.0-Flash Delivering Top-Tier Performance at a Fraction of the Parameter Scale27.7.2026 08:00:00 CEST | Press release
Ant Group today announced the release of Ling-3.0-Flash, a next-generation native hybrid-reasoning foundational model engineered specifically for production-grade AI agent workflows. Designed to deliver rapid response capabilities, it serves as a high-speed execution node that offers a superior balance of intelligence density and cost-efficiency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260726584441/en/ Ling-3.0-Flash delivers strong performance across multiple core benchmarks. Featuring 124B total parameters with only 5.1B active parameters per token, Ling-3.0-Flash achieves remarkable performance despite its streamlined footprint. It matches or surpasses industry-leading models with two to three times its parameter scale across core benchmarks, including foundational reasoning, instruction following, and long-context processing. Architectural Innovation for Efficiency Ling-3.0-Flash moves away from the traditional ap
SES Statement On FCC Upper C-band Auction Decision27.7.2026 07:30:00 CEST | Press release
SES, a leading space solutions company, issued the following statement following the U.S. Federal Communications Commission approval of the Upper C-band Report & Order that makes 160 megahertz of the Upper C-band available in the contiguous United States for flexible-use, next-generation terrestrial wireless services via a system of competitive bidding. The required auction of the Upper C-band will be completed no later than July 2027, with spectrum clearing deadlines in 2030 and 2031. Gross incentive payments of approximately $5.6 billion to SES are contingent on spectrum clearing within the transition deadlines. The Order also confirms reimbursement of reasonable and necessary Upper C-band transition costs as approved by the clearinghouse. SES CEO Adel Al-Saleh Commented: “We commend Chairman Carr and the FCC staff for their diligence, speed, and hard work. We remain fully committed to working cooperatively with the FCC and all stakeholders as the process progresses. We are pleased t
LTM and Cognition Partner to Reduce Cyber Risk in Financial Services with Devin27.7.2026 07:00:00 CEST | Press release
LTM, the Business Creativity partner to the world's largest enterprises, today announced a strategic partnership with Cognition, the AI lab behind the software engineering agent Devin. As a part of this partnership, LTM has onboarded Devin, Cognition’s Autonomous AI Engineer as part of BlueVerseTM RightLogic. LTM BlueVerse RightLogic, is a cybersecurity assessment and risk assurance framework designed to help enterprises identify, assess and remediate cyber exposure as they accelerate AI adoption. Together, the companies will prioritize financial services sector, where Devin is most proven and where LTM brings deep institutional expertise. As AI adoption accelerates, many financial institutions are facing a widening gap between innovation and cyber risk visibility. BlueVerse RightLogic closes this gap by autonomously identifying, prioritizing and remediating vulnerabilities across banking infrastructure, applications, AI systems, software supply chains and governance—including exploits
Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 13:00:00 CEST | Press release
Transaction accelerates Mobix Labs’ global aerial intelligence strategy and National Security Matters Initiative Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performanc
Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 13:00:00 CEST | Press release
Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP)
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