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news.Monte Rosa Therapeutics has announced the clearance of an Investigational New Drug (IND) application by the US Food and Drug Administration (FDA) for MRT-8102.
MRT-8102 is a NEK7-directed molecular glue degrader being developed to treat inflammatory diseases. Credit: National Institute of Allergy and Infectious Diseases by Unsplash.
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MRT-8102 is a NEK7-directed molecular glue degrader being developed to treat inflammatory diseases driven by the NLRP3 inflammasome and IL-1β.
Monte Rosa Therapeutics CEO Markus Warmuth said: “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.
“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 I 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.”
Monte Rosa’s preclinical studies suggest that MRT-8102 could potentially address multiple inflammatory conditions through its targeted mechanism.
The compound has shown promising results in vitro, achieving nanomolar-level degradation of NEK7 without off-target activity, including related NEK family proteins.
Moreover, oral administration of MRT-8102 in non-human primates resulted in near-complete inhibition of inflammatory markers and improvements in disease models.
Monte Rosa is also developing a second-generation NEK7 programme with improved central nervous system (CNS) penetration. The company expects to submit an IND for this programme in 2026.
