- Monte Rosa Therapeutics (NASDAQ: GLUE) received FDA clearance for MRT-8102, advancing its inflammatory disease treatment portfolio.
- MRT-8102 targets NEK7 with nanomolar-level degradation, showing promise in treating cardio-immunology, rheumatology, and respiratory conditions.
- Phase 1 trials are set to start soon, with initial results expected in the first half of 2026.
Monte Rosa Therapeutics, Inc. (GLUE, Financial), a biotechnology company focused on molecular glue degrader (MGD)-based medicines, has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for MRT-8102. This NEK7-directed MGD is being developed to treat multiple inflammatory diseases, marking an important expansion of Monte Rosa's immunology and inflammation (I&I) portfolio.
Preclinical studies of MRT-8102 have demonstrated significant NEK7 degradation at a nanomolar level without off-target effects, showcasing a strong potential safety profile with a 200-fold exposure margin over the projected human efficacious dose. These studies also revealed near-complete inhibition of inflammatory markers in non-human primates, supporting the potential for MRT-8102 to effectively target diseases driven by the NLRP3 inflammasome and IL-1β.
The company plans to commence a Phase 1 clinical study in the coming weeks, focusing on assessing the safety, pharmacokinetics, and protein degradation markers in healthy volunteers. This study will also include proof-of-concept testing on subjects with elevated C-reactive protein (CRP) levels, aiming to provide early efficacy signals concerning inflammatory marker changes.
Monte Rosa retains worldwide rights to MRT-8102 and is advancing a second-generation NEK7 program with enhanced central nervous system (CNS) penetration, with an Investigational New Drug (IND) submission expected in 2026. The company’s strategic approach suggests a promising future in diversifying treatment options for inflammatory diseases.
