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
Globe Newswire•01/10/2026•07:00 ET
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Key Highlights
- ➤MRT-8102 reduced NEK7 approximately 80% to 90% across all three doses
- ➤Calprotectin, S100A12, and SAA fell 56%, 46%, and 51%, respectively
- ➤MRT-8102 treatment-emergent adverse events were 33% versus 30% for placebo
- ➤GFORCE-2 Phase 2b coronary artery disease study expected to initiate H1 2027
- ➤GEMINI-1 gout Phase 2 study expected to initiate Q4 2026 or Q1 2027
Expert Statements
Markus Warmuth, M.D., Chief Executive Officer of Monte Rosa Therapeutics
“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”
Filip Janku, M.D., Ph.D., Chief Medical Officer of Monte Rosa Therapeutics
“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.”
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
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