Monte Rosa Therapeutics announces FDA clearance of IND application for MRT-8102

Monte Rosa Therapeutics (GLUE) announced U.S. Food and Drug Administration, FDA, clearance of an Investigational New Drug, IND, application for MRT-8102, a NEK7-directed MGD being developed for the treatment of inflammatory diseases driven by the NLRP3 inflammasome and IL-1beta. The Company plans to initiate a Phase 1 study of MRT-8102 in the coming weeks and anticipates sharing initial results in H1 2026. “The IND clearance of MRT-8102 is another important milestone in our quest to broadly establish MGDs as a modality in immunology and inflammatory indications. MRT-8102, following on the heels of our VAV1-directed MGD MRT-6160, is our second IND specifically for I&I indications, and represents the only clinical-stage MGD that selectively targets NEK7, with potential to address multiple inflammatory diseases, including cardio-immunology, rheumatology, and respiratory indications,” said Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics. “We believe MRT-8102 could provide a highly differentiated clinical profile compared to IL-1 antibodies and NLRP3 inhibitors in development based on its potency, selectivity, and long-lasting pharmacodynamics. We look forward to initiating a Phase 1 healthy volunteer study in the coming weeks, with clinical results expected in H1 2026, including data on safety, pharmacokinetics, NEK7 protein degradation, and downstream pharmacodynamic markers.”