Monte Rosa Therapeutics, Inc. 8-K

What Happened

• Monte Rosa Therapeutics announced interim Phase 1 results for MRT‑8102 (a NEK7‑directed molecular glue degrader) on January 7, 2026 and hosted a webcast with a presentation (exhibits furnished in the 8‑K). The study included single ascending dose (SAD) cohorts (48 subjects), multiple ascending dose (MAD) cohorts (40 subjects), and a Part 3 cohort where 24 subjects had completed 4 weeks of dosing as of the data cutoff (Dec 23, 2025). MRT‑8102 produced rapid and deep NEK7 degradation (~80–90% in peripheral T cells) and large biomarker effects: an 85% median decrease in hsCRP after four weeks in the Part 3 elevated‑CVD‑risk cohort, with 94% of those subjects reaching hsCRP <2 mg/L (median baseline 6.3 mg/L). Median IL‑6 fell ~55% in high‑CRP subjects; two subjects showed a 75% drop in CSF IL‑6. Reported adverse events were generally mild‑to‑moderate, self‑resolving, with no dose‑dependent increase or evidence of increased infection risk.

Key Details

• Cohort sizes: SAD = 48 subjects; MAD = 40 subjects; Part 3 = 24 subjects completed 4 weeks (data cutoff Dec 23, 2025).
• NEK7 degradation: ~80–90% reduction in peripheral blood T cells across dose levels.
• In Part 3 (elevated CVD risk): hsCRP ↓85% after 4 weeks; 94% of subjects suppressed to <2 mg/L (median baseline 6.3 mg/L).
• Biomarkers/safety: median IL‑6 ↓55% in high‑CRP subjects; two subjects had 75% CSF IL‑6 declines; adverse events were limited, mild/moderate, and non‑dose dependent.

Why It Matters

• These interim results provide early proof‑of‑mechanism evidence that oral NEK7 degradation with MRT‑8102 can substantially lower inflammation biomarkers (hsCRP, IL‑6) linked to cardiovascular risk, while showing a favorable safety profile in early testing. For investors, the data support the company’s plan to advance MRT‑8102 into Phase 2 (GFORCE‑2 planned in 2026) and represent near‑term clinical catalysts (additional GFORCE‑1 data expected H2 2026). As with any interim biomarker readout, final clinical outcomes and larger trials will be needed to confirm clinical benefit.