Monte Rosa Therapeutics(US:GLUE) Globenewswire·2025-06-10 11:00Core Insights - Monte Rosa Therapeutics has received FDA clearance for an Investigational New Drug (IND) application for MRT-8102, a NEK7-directed molecular glue degrader aimed at treating inflammatory diseases linked to NLRP3, IL-1β, and IL-6 dysregulation [1][2] - The company plans to initiate a Phase 1 clinical study of MRT-8102 shortly, with initial results expected in the first half of 2026, focusing on safety, pharmacokinetics, and NEK7 protein degradation [1][2] Company Overview - Monte Rosa Therapeutics is a clinical-stage biotechnology company developing novel molecular glue degrader (MGD) medicines for serious diseases, particularly in oncology and inflammatory conditions [5][6] - The company utilizes its QuEEN™ discovery engine, which combines AI-guided chemistry and structural biology, to design MGDs with high selectivity [6] Product Details - MRT-8102 is characterized as a potent, highly selective, and orally bioavailable investigational MGD that targets NEK7, crucial for NLRP3 inflammasome assembly and IL-1β release [4] - Preclinical studies have shown MRT-8102's ability to achieve nanomolar-level degradation of NEK7 without off-target activity, and it has demonstrated significant efficacy in reducing inflammatory markers in various models [2][4] Clinical Development - The Phase 1 study will also aim to establish initial proof-of-concept for cardio-immunology indications by evaluating changes in C-reactive protein (CRP) and other inflammatory markers in subjects with elevated CRP levels [2] - Monte Rosa is also advancing a second-generation NEK7 program with enhanced CNS penetration, with an IND submission expected in 2026 [3] Market Position - MRT-8102 is positioned as a unique clinical-stage MGD that selectively targets NEK7, potentially addressing multiple inflammatory diseases, including those in cardio-immunology, rheumatology, and respiratory indications [2][4]