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Monte Rosa Doses First Patients in Phase 1 MRT-8102 Study for Inflammatory Diseases
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Monte Rosa Therapeutics has announced a significant step forward in the development of novel treatments for inflammatory diseases with the first patients dosed in a Phase 1 study of MRT-8102. This investigational medicine is a pioneering NEK7-directed molecular glue degrader (MGD), a new class of oral therapeutics designed to precisely target and degrade specific proteins. MRT-8102 is being developed to address inflammatory conditions driven by the NLRP3 inflammasome, IL-1β, and IL-6 pathways, which are implicated in a wide array of disorders, including cardiovascular disease, gout, osteoarthritis, and certain neurological conditions like Parkinson's and Alzheimer's.

The Phase 1 study for MRT-8102 is a crucial step to evaluate its safety, tolerability, pharmacokinetics (how the drug moves through the body), and pharmacodynamics (how it affects the body). This randomized, double-blind, placebo-controlled trial will include both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts in healthy volunteers. A key aspect of the pharmacodynamic assessment will be observing the degradation of the NEK7 protein and how the inflammasome responds ex vivo to stimulation. Initial results from these cohorts are eagerly anticipated in the first half of 2026.

What makes this study particularly noteworthy is the inclusion of a dedicated cohort for subjects with increased cardiovascular disease (CVD) risk and elevated C-reactive protein (CRP). This strategic decision aims to garner early proof-of-concept data for MRT-8102 in cardio-immunology indications such as pericarditis and atherosclerotic cardiovascular disease. By evaluating changes in CRP levels and other inflammatory markers in this specific population, Monte Rosa hopes to gain valuable insights that will guide the future development of MRT-8102 for a broader range of inflammatory conditions.

As Markus Warmuth, M.D., CEO of Monte Rosa Therapeutics, highlighted, MRT-8102 is currently the only clinical-stage MGD that selectively targets NEK7. This selectivity, combined with the promising potency and durable pharmacodynamics observed in preclinical studies, positions MRT-8102 as a potentially differentiated approach to treating complex inflammatory diseases. The initiation of this Phase 1 study represents a significant milestone for Monte Rosa's immunology and inflammation pipeline, offering new hope for patients with conditions previously difficult to treat.

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