Tourmaline Bio Announces Positive Topline Results from the Ongoing Phase 2 TRANQUILITY Trial Evaluating Pacibekitug in Patients with Elevated High-Sensitivity C-reactive Protein and Chronic Kidney Disease

Core Insights - Tourmaline Bio, Inc. announced positive topline results from its Phase 2 TRANQUILITY trial for pacibekitug, an IL-6 inhibitor, showing significant reductions in high-sensitivity C-reactive protein (hs-CRP) levels, a biomarker for cardiovascular risk [1][2][3] Trial Overview - The TRANQUILITY trial is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study involving patients with elevated hs-CRP and chronic kidney disease (CKD) stages 3 or 4 [3][4] - Participants were assigned to receive pacibekitug at different dosing regimens or placebo over a treatment period of 6 months, followed by an additional 6 months of follow-up [3][4] Efficacy Results - All active treatment arms achieved rapid, deep, and durable reductions in hs-CRP, with the 50 mg quarterly dosing arm achieving an 86% reduction from baseline [1][9] - The primary endpoint showed a median time-averaged percent reduction in hs-CRP through Day 90 of 86% for the 50 mg quarterly group, compared to 15% for placebo [9] - The percentage of participants achieving hs-CRP levels below 2 mg/L was 83% in the 50 mg quarterly group, compared to 13% in the placebo group [9] Safety Profile - The overall incidence of adverse events (AEs) in the pacibekitug groups was comparable to placebo, with 54% in the pooled pacibekitug group versus 56% in the placebo group [10][11] - Serious adverse events (SAEs) occurred in 10% of the pacibekitug group compared to 11% in the placebo group, indicating a similar safety profile [10][11] - The most common AEs included urinary tract infections and COVID-19, with the majority being mild or moderate in severity [10][11] Future Development Plans - Tourmaline plans to advance pacibekitug into a Phase 3 cardiovascular outcomes trial for atherosclerotic cardiovascular disease (ASCVD) and a Phase 2 proof-of-concept trial for abdominal aortic aneurysm (AAA) [14][15] - The company anticipates sharing further data from the TRANQUILITY trial at upcoming medical conferences [2][14] Company Background - Tourmaline Bio is a late-stage clinical biotechnology company focused on developing transformative medicines for immune and inflammatory diseases, with pacibekitug as its lead asset [19][20]