The investigational anti-interleukin-6 (IL-6) monoclonal antibody pacibekitug produced sustained reductions in inflammation-related biomarkers through six months in patients with chronic kidney disease and elevated inflammatory risk associated with heart disease.
These are the significant final findings from the "TRANQUILITY" phase 2 clinical trial evaluating the safety and efficacy of the therapy. The results were presented August 29 in a Hot Line Session at the European Society of Cardiology Congress (ESC 2026) in Munich, Germany, by Deepak L. Bhatt, MD, MPH, Director of Mount Sinai Fuster Heart Hospital.
"These findings demonstrate that durable suppression of the IL-6 pathway is achievable with infrequent dosing of a long-acting monoclonal antibody," explains Dr. Bhatt, who is also the Dr. Valentin Fuster Professor of Medicine at the Icahn School of Medicine at Mount Sinai. "The next critical step is to determine whether the effects observed in TRANQUILITY translate into improved cardiovascular outcomes in patients with elevated inflammatory cardiovascular risk."
Inflammation is increasingly recognized as an important contributor to cardiovascular disease. IL-6 is a signaling protein involved in inflammatory pathways that has been associated with cardiovascular risk. Pacibekitug is an investigational long-acting monoclonal antibody designed to target IL-6 and reduce inflammatory activity.
TRANQUILITY is a phase 2 study evaluating the safety and durability of pacibekitug 180 days after treatment. Earlier analyses demonstrated substantial reductions in inflammatory biomarkers through 90 days. The current analysis evaluated the durability of those effects through 180 days, as well as safety and tolerability.
This randomized, double-blind, placebo-controlled study enrolled 143 adults with chronic kidney disease and elevated high-sensitivity C-reactive protein (hsCRP), a marker of inflammation. Participants were randomized to receive placebo or one of three pacibekitug dosing regimens and were followed for 180 days. Pacibekitug treatment resulted in substantial and sustained reductions in hsCRP across all treatment groups through day 180, together with favorable effects on additional biomarkers associated with IL-6 pathway activity and cardiovascular risk. Pacibekitug was generally well tolerated, and no new safety signals were identified.
Results showed that on day 180, time-averaged hsCRP reductions ranged from 76 percent to 89 percent across pacibekitug treatment groups, compared with a 7 percent increase in the placebo group.
Our next focus is to determine whether the biomarker effects observed in TRANQUILITY translate into improved cardiovascular outcomes in larger studies. These findings support continued evaluation of IL-6 inhibition in patients with elevated inflammatory cardiovascular risk."
Dr. Deepak L. Bhatt, MD, MPH, Director of Mount Sinai Fuster Heart Hospital
The TRANQUILITY trial was sponsored by Tourmaline Bio, Inc., a Novartis company. Dr. Bhatt had chaired the Scientific Advisory Board for Tourmaline Bio and receives research funding from Novartis for this trial.
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