Pacibekitug shows consistent reductions in hs-CRP across clinically-meaningful subgroups.

Tourmaline Bio presented data from its Phase 2 TRANQUILITY trial of pacibekitug, highlighting consistent reductions in high-sensitivity C-reactive protein (hs-CRP) across clinically-meaningful subgroups. Pacibekitug also demonstrated concordant, statistically significant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity, including lipoprotein(a), fibrinogen, and serum amyloid A. The results were presented at the European Society of Cardiology Congress 2025 in Madrid, Spain.

Tourmaline Bio, Inc. (NASDAQ: TRML) has presented additional data from its ongoing Phase 2 TRANQUILITY trial of pacibekitug at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain. The data highlights consistent reductions in high-sensitivity C-reactive protein (hs-CRP) across clinically-meaningful subgroups and concordant, statistically significant reductions in secondary pharmacodynamic biomarkers of the IL-6 pathway activity, including lipoprotein(a), fibrinogen, and serum amyloid A.

The poster presentation, titled "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Ph2 Trial of Pacibekitug SC Quarterly or Monthly in Patients with Elevated hs-CRP and Chronic Kidney Disease: TRANQUILITY 90-Day Results," was presented by Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital and Chair of Tourmaline’s Cardiovascular Scientific Advisory Board. The data presented builds upon the topline results reported in May 2025, showing that pacibekitug demonstrated rapid, deep, and consistent reductions in hs-CRP across all monthly and quarterly dosing arms, with statistically significant reductions compared to placebo (p0.0001 for all arms).

The TRANQUILITY trial, which evaluates pacibekitug in patients with elevated hs-CRP and chronic kidney disease (CKD), achieved 85% hs-CRP reductions from baseline in the 50 mg quarterly arm. This makes pacibekitug the first and only IL-6 inhibitor to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial. The reductions in fibrinogen and serum amyloid A were statistically significant in all three pacibekitug dose arms, while reductions in lipoprotein(a) were statistically significant in the 50mg quarterly and 15mg monthly arms.

These results support Tourmaline’s plans to initiate a Phase 2 proof-of-concept study in abdominal aortic aneurysm (AAA) and to continue its preparations for a Phase 3 cardiovascular outcomes trial in patients with atherosclerotic cardiovascular disease (ASCVD).

The poster presentation was part of the ESC Congress 2025, held from August 31, 2025, 3:15 – 4:00 pm CEST, with abstract number #599. The full poster is available on the ESC Congress website and the Publications section of Tourmaline’s website.

References:
[1] https://www.globenewswire.com/news-release/2025/08/31/3141921/0/en/Tourmaline-Bio-Presents-Data-from-the-Ongoing-Phase-2-TRANQUILITY-Trial-at-the-2025-European-Society-of-Cardiology-Congress.html
[2] https://www.stocktitan.net/news/TRML/tourmaline-bio-presents-data-from-the-ongoing-phase-2-tranquility-ifpio45woe3c.html