An investigational monoclonal antibody called pacibekitug produced sustained reductions in inflammation-related biomarkers through six months in chronic kidney disease patients at high inflammatory risk, according to phase II clinical trial results presented August 29, 2026, at the European Society of Cardiology Congress in Munich.
Cardiovascular disease remains a persistent global challenge, and standard medical interventions targeting traditional risk factors such as smoking, hypertension, high cholesterol, and diabetes only account for roughly half of the worldwide disease burden. A meaningful share of patients—roughly 30 percent of those with atherosclerotic cardiovascular disease and about 40 percent of individuals with concurrent chronic kidney disease—remain at high inflammatory risk even after receiving standard therapies, driven by elevated levels of the inflammatory marker high-sensitivity C-reactive protein (hs-CRP).
To address this residual risk, researchers evaluated a long-acting monoclonal antibody designed to target interleukin-6 (IL-6), a signaling protein known to mediate key inflammatory pathways linked to cardiovascular events. The investigation centered on pacibekitug, an experimental biologic agent tested in a phase II trial known as TRANQUILITY.
Trial Design and Patient Demographics in the TRANQUILITY Study
The placebo-controlled phase II study was conducted across 49 clinical centers in the United States, enrolling 143 adult patients diagnosed with stage 3 to stage 4 chronic kidney disease alongside elevated hs-CRP levels ranging from 2 to less than 15 milligrams per liter (hsCRP). Study participants had a mean age of 69 years, with women comprising 64 percent of the cohort. Additionally, 72 percent of the study participants were taking statins, and 59 percent had a diagnosis of diabetes.
Participants were randomized in a 1:1:1:1 ratio to receive one of several subcutaneous dosing regimens or a placebo over a six-month evaluation window. The active treatment arms received either pacibekitug 25 milligrams every 90 days, 50 milligrams every 90 days, or 15 milligrams every 30 days. The trial aimed to evaluate not only intermediate biomarker changes at 90 days, but also the safety, tolerability, and durability of the suppression through 180 days.
Biomarker Reductions and Sustained Suppression Through 180 Days
Data presented at the ESC Congress 2026 demonstrated that pacibekitug treatment achieved dose-dependent decreases in hs-CRP by day 30, and those reductions held steady through the end of the 180-day observation period. Median time-averaged changes in hs-CRP from baseline through day 180 showed a 7 percent increase in the placebo group, contrasted with substantial decreases across all active treatment arms (all p<0.0001 vs. placebo).
| Treatment Arm | Dosing Schedule | Time-Averaged hs-CRP Change Through Day 180 |
|---|---|---|
| Placebo | Various schedules | +7% increase |
| Pacibekitug 25 mg | Every 90 days | −76% reduction |
| Pacibekitug 50 mg | Every 90 days | −85% reduction |
| Pacibekitug 15 mg | Every 30 days | −89% reduction |
In addition to suppressing hs-CRP, treatment with the antibody led to sustained reductions in other key inflammatory markers, as well as favorable changes in fibrinogen and lipoprotein(a). The therapy maintained a strong safety and tolerability profile, resulting in few trial discontinuations at 1.9 percent and exhibiting no clear dose-related safety signals.
Next Steps for Interleukin-6 Inhibition in Cardiovascular Medicine
The clinical trial was sponsored by Tourmaline Bio, Inc., a Novartis company. Deepak L. Bhatt, MD, MPH—who serves as Director of Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Medicine at the Icahn School of Medicine at Mount Sinai—chaired the Scientific Advisory Board for Tourmaline Bio and receives research funding from Novartis for this clinical program.
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