MRM Health’s Lead Candidate MH002 Granted Fast Track Designation by U.S. FDA for the Treatment of Mild-to-Moderate Ulcerative Colitis
MRM Health, a clinical-stage biopharmaceutical company developing therapeutics for immune-mediated diseases, which unlock the power of the microbiome to restore immune balance, today announced that MH002, the Company’s lead rationally designed Live Biotherapeutic Product (LBP) candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of mild-to-moderate ulcerative colitis (UC). MH002 today is the most advanced LBP targeting inflammatory bowel disease (IBD)-specific mechanisms and is composed of a rationally designed microbial consortium of six well-characterized commensal strains.
MRM Health Secures FDA IND Clearance to Launch its Phase 2b Trial of MH002 in Mild-to-Moderate Ulcerative Colitis
MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance of its Investigational New Drug (IND) application for its lead program MH002. This enables the initiation of the STARFISH-UC Phase 2b clinical trial in patients with mild-to-moderate ulcerative colitis, marking a significant step forward in the development of next-generation therapies for inflammatory bowel diseases (IBD).
MRM Health Raises €55 Million Series B to Advance Best-in-Class Microbiome-Based Biotherapeutic Product Pipeline
MRM Health NV, a clinical-stage biopharmaceutical company pioneering microbiome-based therapeutics for inflammatory diseases and immune-oncology, today announced the successful closing of a €55 million (US$64 million) Series B financing round.
MRM Health Reports Safety and Positive Efficacy Data in Pouchitis in Phase 2a Clinical Study with MH002
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 Reports Positive Topline Results from Phase 2a Clinical Study with MH002 in Mild-to-Moderate Ulcerative Colitis
MRM Health NV, a clinical-stage biopharmaceutical company focused on developing next-generation live microbiome consortia therapeutics, today reports positive topline results from its Phase 2a clinical trial with MH002 in mild-to-moderate Ulcerative Colitis (UC).
