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Monte Rosa Therapeutics Announces FDA Clearance of IND Application for MRT-8102, a NEK7-Directed Molecular Glue Degrader for the Treatment of Multiple Inflammatory Diseases
MRT-8102, a highly selective NEK7-directed molecular glue degrader (MGD) developed to treat inflammatory conditions linked to NLRP3, IL-1β, and IL-6 dysregulation, expands Monte Rosa’s clinical I&I portfolio Potency, selectivity, and long-lasting pharmacodynamics of MRT-8102 observed in preclinical studies create potential for clinical differentiation from competitive approaches for inflammatory diseases MRT-8102 Phase 1 clinical results, including data on safety, pharmacokinetics, NEK7 protein
About this update from Monte Rosa Therapeutics, Inc.
[{"type":"image","alt":"Monte Rosa Therapeutics, Inc.","displaySize":"","headline":null,"caption":"Monte Rosa Therapeutics, Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":82,"url":"https://media.zenfs.com/en/globenewswire.com/c99f028be58427489eba79299e175651"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/OzxkCVdlx.rHq4uLVBRKVA--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTExNTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/c99f028be58427489eba79299e175651","width":300,"height":82}},"lazy":false},{"type":"text","content":"MRT-8102, a highly selective NEK7-directed molecular glue degrader (MGD) developed to treat inflammatory conditions linked to NLRP3, IL-1β, and IL-6 dysregulation, expands Monte Rosa’s clinical I&I portfolio","length":211,"tagName":"p"},{"type":"text","content":"Potency, selectivity, and long-lasting pharmacodynamics of MRT-8102 observed in preclinical studies create potential for clinical differentiation from competitive approaches for inflammatory diseases","length":199,"tagName":"p"},{"type":"text","content":"MRT-8102 Phase 1 clinical results, including data on safety, pharmacokinetics, NEK7 protein degradation, and key downstream pharmacodynamic markers, expected in H1 2026","length":168,"tagName":"p"},{"type":"text","content":"BOSTON, June 10, 2025 (GLOBE NEWSWIRE) -- Monte Rosa Therapeutics, Inc. (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, today 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-1β. The Company plans to initiate a Phase 1 study of MRT-8102 in the coming weeks and anticipates sharing initial results in H1 2026.","length":572,"tagName":"p"},{"type":"text","content":"“The IND clearance of MRT-8102 is another important milestone in our quest to broadly establish MGDs as a modality in immunology and inflammatory (I&I) 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-immuno...