Core Insights - Tourmaline Bio, Inc. presented additional data from its Phase 2 TRANQUILITY trial of pacibekitug, demonstrating consistent reductions in high-sensitivity C-reactive protein (hs-CRP) across various patient subgroups [1][2][6] - The trial results support the potential of pacibekitug as a treatment for atherosclerotic cardiovascular disease and other inflammation-driven cardiovascular diseases [3][4] Group 1: Trial Details - The TRANQUILITY trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study evaluating pacibekitug in patients with elevated hs-CRP and chronic kidney disease [8] - The primary endpoint is the median time-averaged percent change in hs-CRP through Day 90, with a key secondary endpoint of participants achieving time-averaged hs-CRP below 2 mg/L [8] Group 2: Efficacy Results - Pacibekitug achieved rapid, deep, and consistent reductions in hs-CRP, with statistical significance (p<0.0001) across all dosing arms compared to placebo [3][4] - The treatment also demonstrated statistically significant reductions in secondary biomarkers including lipoprotein(a), fibrinogen, and serum amyloid A, indicating its potential impact on cardiovascular risk [3][6] Group 3: Future Plans - Based on the trial results, Tourmaline plans to initiate a Phase 2 proof-of-concept study in abdominal aortic aneurysm (AAA) and continue preparations for a Phase 3 cardiovascular outcomes trial in patients with atherosclerotic cardiovascular disease (ASCVD) [4]
Tourmaline Bio Presents Data from the Ongoing Phase 2 TRANQUILITY Trial at the 2025 European Society of Cardiology Congress