Tourmaline Bio Presents Consistent hs-CRP Reductions with Pacibekitug Across Subgroups at ESC Congress 2025

Tourmaline Bio presented data from its ongoing Phase 2 TRANQUILITY trial at the European Society of Cardiology Congress 2025, highlighting consistent reductions in high-sensitivity C-reactive protein with pacibekitug across various subgroups. Pacibekitug also demonstrated concordant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity, including lipoprotein(a), fibrinogen, and serum amyloid A. These results support further evaluation of pacibekitug in atherosclerotic cardiovascular disease and other inflammation-driven cardiovascular diseases.

Tourmaline Bio, Inc. (TRML) presented data from its ongoing Phase 2 TRANQUILITY trial at the European Society of Cardiology Congress 2025, showcasing consistent reductions in high-sensitivity C-reactive protein (hs-CRP) with pacibekitug across various subgroups. The company highlighted that pacibekitug demonstrated concordant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity, including lipoprotein(a), fibrinogen, and serum amyloid A.

The data, presented in a poster by Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital, underscored pacibekitug's effectiveness in reducing inflammation, a key risk factor for cardiovascular diseases. The results support further evaluation of pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and other inflammation-driven cardiovascular diseases.

Pacibekitug, a long-acting anti-IL-6 monoclonal antibody, achieved rapid, deep, and consistent reductions in hs-CRP across all dosing arms, with a high degree of statistical significance compared to placebo (p0.0001 for all arms). These reductions were consistent across various clinically relevant subgroups, including sex, body mass index, presence or absence of diabetes, baseline GLP-1 and GIP/GLP-1 receptor agonist use, and baseline hs-CRP level.

Additionally, pacibekitug demonstrated statistically significant reductions in fibrinogen and serum amyloid A in all three dose arms, and in lipoprotein(a) in the 50mg quarterly and 15mg monthly arms. These results make a strong case for pacibekitug's continued evaluation in ASCVD and other inflammation-driven cardiovascular diseases.

The TRANQUILITY trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating pacibekitug in patients with elevated hs-CRP and chronic kidney disease (CKD). The primary endpoint of the trial is median time-averaged percent change in hs-CRP through Day 90, with the key secondary endpoint being the percentage of participants achieving time-averaged hs-CRP below 2 mg/L through Day 90.

Tourmaline Bio's lead asset, pacibekitug, has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. The company is currently developing pacibekitug in ASCVD and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future.

The data presented at the ESC Congress 2025 further supports Tourmaline's plans to initiate a Phase 2 proof-of-concept study in AAA and to continue its preparations for a Phase 3 cardiovascular outcomes trial in patients with ASCVD.

References:
[1] https://www.stocktitan.net/news/TRML/tourmaline-bio-presents-data-from-the-ongoing-phase-2-tranquility-ifpio45woe3c.html
[2] https://www.nature.com/articles/s44161-025-00700-7