Clinical-stage biotechnology company Monte Rosa Therapeutics Inc. (NASDAQ:GLUE) on Wednesday revealed interim data from an ongoing Phase 1 study of MRT-8102 for the treatment of inflammatory conditions driven by the NLRP3 inflammasome, IL-1, and IL-6.
The study is designed to evaluate safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy volunteers.
Part 3 of the Phase 1 study is enrolling subjects with increased cardiovascular disease (CVD) risk due to obesity and elevated CRP, designed to evaluate safety and tolerability, changes in CRP levels, pharmacokinetics, and changes in other inflammatory markers.
Key Interim Study Results
Single ascending dose (SAD) and multiple ascending dose (MAD) cohorts enrolled 48 and 40 subjects, respectively.
In the Part 3 cohort, 24 subjects have completed 4 weeks of dosing.
Rapid, deep, and sustained degradation of NEK7 was observed in peripheral blood T cells (around 80 to 90%) across all dose levels.
MRT-8102 led to significant reductions in serum hsCRP across all dose levels following single-dose drug administration and 7-day multiple-dose drug administration.
In the MAD cohorts, MRT-8102 led to marked suppression of IL-1β secretion in patients with elevated CRP levels at baseline.
When analyzing high CRP subjects across all dose levels, significant reductions of endogenous IL-6 were observed, with median IL-6 levels dropping by 55% to levels below the cardiovascular risk threshold.
In two subjects with elevated basal levels of cerebrospinal fluid (CSF) IL-6, a significant decrease of 75% in CSF IL-6 was noted.
Plasma IL-6 levels at baseline for these two subjects were low, potentially suggesting central nervous system /CSF-specific effects of MRT-8102.
In Part 3 of the study, MRT-8102 resulted in a decrease of hsCRP of 85% after four weeks of dosing, compared with no significant change in hsCRP for the placebo group.
In addition, 94% of subjects showed suppression of hsCRP to <2mg/L after four weeks of dosing, a threshold associated with reduced CVD risk.
Favorable safety profile observed with mild to moderate adverse events (AEs) and no evidence of increased infection risk.
Immunology and Inflammation Program Milestones
Monte Rosa Therapeutics expects several key data readouts and clinical advances across its immunology and inflammation pipeline in 2026.
Topline results from the Phase 1 GFORCE-1 study of MRT-8102 in subjects with elevated cardiovascular disease risk are anticipated in the second half of 2026.
The company also plans to initiate the Phase 2 GFORCE-2 trial of MRT-8102 in patients with atherosclerotic cardiovascular disease (ASCVD) during 2026.
In parallel, Monte Rosa expects its collaborator, Novartis AG, to advance the VAV1-directed molecular glue degrader MRT-6160 into multiple Phase 2 studies across immune-mediated diseases in 2026.
Monte Rosa expects its collaborator, Novartis AG (NYSE:NVS), to initiate multiple Phase 2 studies of VAV1-directed MGD MRT-6160 in immune-mediated diseases in 2026.
Oncology Program Milestones
Monte Rosa plans to advance its oncology pipeline with the initiation of the MODeFIRe-1 Phase 2 trial of MRT-2359 in 2026. The study will evaluate MRT-2359 in combination with a second-generation androgen receptor inhibitor in patients with castration-resistant prostate cancer (CRPC).
The company also expects to present updated clinical data from the ongoing Phase 1/2 study of MRT-2359 at the ASCO Genitourinary Cancers Symposium in February 2026.
GLUE Price Action: Monte Rosa Therapeutics shares were up 53.28% at $24.54 at the time of publication on Wednesday. The stock is trading at a new 52-week high, according to Benzinga Pro data.
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