Monte Rosa Therapeutics Gets FDA IND Clearance For MRT-8102, A NEK7-Targeting Molecular Glue Degrader For Multiple Inflammatory Diseases

Monte Rosa Therapeutics, Inc., a clinical-stage biotechnology company focused on developing novel molecular glue degrader (MGD)-based therapies, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRT-8102. This NEK7-targeting MGD is being developed to treat inflammatory diseases that are driven by the NLRP3 inflammasome and IL-1β. The company plans to begin a Phase 1 clinical trial of MRT-8102 in the coming weeks and expects to share initial data from the study in the first half of 2026.

Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics, mentioned, “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-immunology, rheumatology, and respiratory indications.”

He further added, “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. As part of the Phase 1 study, we plan to establish initial proof-of-concept (POC) for cardio-immunology indications by evaluating changes in C-reactive protein (CRP) and other key inflammatory markers in a cohort of subjects with high CRP levels.”

The IND clearance is based on encouraging preclinical results. Monte Rosa’s studies have shown that MRT-8102 is capable of degrading NEK7 at nanomolar concentrations in vitro without affecting related NEK family proteins. In non-human primates, oral dosing of MRT-8102 led to near-complete inhibition of downstream inflammatory markers in ex vivo assays and improvements in disease-related pathology in various inflammatory disease models. 

In a rabbit model of gout, daily oral administration of the compound was associated with a reduction in joint swelling and improved histopathology scores. Additionally, GLP toxicology studies in both rats and non-human primates suggest a strong safety margin, with over 200-fold exposure above the anticipated effective dose in humans. Beyond MRT-8102, Monte Rosa is progressing a second-generation NEK7-targeted program that features enhanced penetration into the central nervous system. The company anticipates submitting an IND for this program in 2026. Monte Rosa retains global rights to both MRT-8102 and its next-generation NEK7-directed MGDs.