Press release
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Monte Rosa Therapeutics Monte Rosa Therapeutics Announces Positive Results for MRT - 8102 in GFORCE - 1 Phase 1 Study Showing Normalization of Key Pathogenic Drivers of ASCVD in Subjects with Elevated CVD Risk 10.1.2026 In obese subjects at elevated cardiovascular disease ( CVD ) risk , MRT - 8102 , a NEK7 - directed molecular glue degrader in development for the treatment of NLRP3 / IL - 1 - driven inflammatory diseases , normalized multiple atherosclerotic cardiovascular disease ( ASCVD ) pathogenic drivers of local plaque inflammation , thrombosis , and systemic inflammation Robust and sustained NEK7 degradation observed across 5 mg , 20 mg , and 40 mg once - daily dose levels , with similar biomarker reductions at all three doses HMGB1 , calprotectin , S100A12 , and SAA , damage - associated molecular patterns ( DAMPs ) linked to atherosclerotic plaque progression and instability , and IL - 1ẞ , all established key pathogenic drivers of ASCVD , were reduced to levels comparable to normal physiological levels seen in the healthy volunteer population of Phase 1 study MRT - 8102 was safe and well tolerated over four weeks of dosing and four weeks of follow - up , with no serious adverse events , treatment - emergent adverse event rates comparable to placebo , and no evidence of increased infection risk Phase 2 trials planned across coronary artery disease ( GFORCE - 2 ) , gout ( GEMINI - 1 ) , and moderate to severe hidradenitis suppurativa ( GALAXY - 1 ) Company to host conference call and webcast today , Oct. 1 , at 8:00 a.m. ET BOSTON , Oct. 01 , 2026 ( GLOBE NEWSWIRE ) -- Monte Rosa Therapeutics , Inc. ( Nasdaq : GLUE ) , a clinical - stage biotechnology company developing novel molecular glue degrader ( MGD ) -based medicines , today announced positive data from GFORCE - 1 , a Phase 1 study evaluating MRT - 8102 , a NEK7 - directed MGD being developed for the treatment of inflammatory conditions driven by the NEK7 / NLRP3 pathway . " The GFORCE - 1 data are highly encouraging and show that MRT - 8102 does precisely what we designed it to do : potently and selectively degrade NEK7 and reduce levels of upstream and downstream drivers of residual plaque inflammation and thrombotic risk , and it does so with a differentiated and favorable safety profile , " said Markus Warmuth , M.D. , Chief Executive Officer of Monte Rosa Therapeutics . " We are particularly excited about our translational approach , including our unique and broad analysis of the NEK7 / NLRP3 upstream pathway , that has allowed us to gain unprecedented insights into how inhibition of the pathway through NEK7 degradation leads to normalization of many of the most important drivers of atherosclerotic plaque formation , progression , and rupture . To that end , we observed compelling reductions of HMGB1 , calprotectin , S100A12 , SAA , and IL - 1ẞ . These DAMPs and cytokines are linked to pathogenic biology within atherosclerotic plaques and vessel walls , and they have been identified as independent risk factors of much greater significance than some of the systemic inflammatory markers evaluated in other studies . We have also seen intriguing correlation of these markers with NLRP3 risk alleles , opening up opportunities for a precision medicine approach . The GFORCE - 1 study results , alongside a body of genetic , biological , and clinical data , reinforce our rationale for degrading NEK7 to simultaneously dampen multiple key ASCVD disease drivers that can lead to atherosclerosis , plaque progression , and thrombogenesis . We believe targeting NEK7 at the top of the NLRP3 signaling cascade has the potential to provide a degree of clinical impact across NEK7 / NLRP3 - driven diseases not achievable by targeting individual downstream cytokines . " Filip Janku , M.D. , Ph.D. , Chief Medical Officer of Monte Rosa Therapeutics , commented , " We believe our results represent the most comprehensive translational data set reported to date for the NEK7 / NLRP3 pathway . GFORCE - 1 was designed to provide a broad view of the pharmacodynamic activity and safety of MRT - 8102 , and the profile we observed further bolsters our enthusiasm for continued development in cardiovascular disease and other indications . With dose selection now informed by these data , we plan to initiate GFORCE - 2 , a focused Phase 2b study in patients with coronary artery disease , in the first half of 2027. In GFORCE - 2 , our goal is to connect imaging - based coronary artery plaque assessment , such as fat attenuation index ( FAI ) , with NLRP3 genetics and molecular drivers of local disease pathogenesis and systemic inflammation to inform the design of an innovative and efficient Phase 3 study focused on the most disease - modifiable patient population . We also expect to initiate GEMINI - 1 , a Phase 2 study in gout , in Q4 2026 or Q1 2027 , and GALAXY - 1 , a Phase 2 study in moderate to severe hidradenitis suppurativa , in the first half of 2027 , representing additional substantial opportunities associated with this pathway . " GFORCE - 1 ( clinicaltrials.gov identifier NCT07119125 ) enrolled 108 obese subjects with elevated CVD risk , randomized to MRT - 8102 at once - daily doses of 5 mg , 20 mg , or 40 mg , or to placebo . The GFORCE - 1 study followed best - in - class data from