Tourmaline Bio Unveils Phase 2 TRANQUILITY Study at 2024 ASPC Congress

Tourmaline Bio, Inc. (NASDAQ: TRML), a late-stage clinical biotechnology company, recently presented a comprehensive overview of its Phase 2 TRANQUILITY study at the American Society of Preventive Cardiology (ASPC) Congress in Salt Lake City, Utah. The study aims to evaluate the potential of TOUR006, the company's lead candidate, in reducing high-sensitivity C-reactive protein (hs-CRP) levels among patients with chronic kidney disease (CKD) who have elevated hs-CRP.

Chronic kidney disease patients with elevated hs-CRP are at an increased risk of developing atherosclerotic cardiovascular disease (ASCVD), which can lead to severe conditions such as heart attack, stroke, and peripheral artery disease. Despite existing standard treatments, these patients continue to face significant cardiovascular risks. TOUR006 has previously shown efficacy in lowering hs-CRP levels in patients with inflammatory autoimmune diseases, indicating its potential for broader applications.

Dr. Emil deGoma, Senior Vice President of Medical Research at Tourmaline, highlighted the significance of the TRANQUILITY study. According to Dr. deGoma, this trial is a critical step toward addressing the unmet needs of patients who remain at residual cardiovascular risk despite lifestyle modifications and available treatments. He emphasized the robust clinical data supporting TOUR006, derived from six prior trials involving 448 participants, which includes healthy volunteers and patients with various inflammatory autoimmune conditions. This background provides a strong foundation for the ongoing study.

The TRANQUILITY study is designed with the objective of assessing the hs-CRP-lowering effect, safety, tolerability, and pharmacokinetics of TOUR006 in CKD patients. It is a randomized, double-blind, placebo-controlled trial involving approximately 120 participants with CKD stage 3 or 4 and an hs-CRP level of 2 or higher. Participants are stratified by their CKD stage and randomized to receive subcutaneous injections of TOUR006 at varying doses: 50 mg quarterly, 25 mg quarterly, 15 mg monthly, or a placebo. The primary pharmacodynamic endpoint is the change in hs-CRP levels. Other biomarkers being measured include IL-6, lipoprotein(a), oxidized low-density lipoprotein (LDL), and fibrinogen.

The study spans a treatment period of 180 days followed by a 185-day follow-up period. The primary completion of the trial is anticipated in May 2025. The data collected from this trial is expected to inform the dosing regimen and design of future Phase 3 studies in high-risk cardiovascular patients.

TOUR006 is a long-acting, fully human, anti-IL-6 monoclonal antibody with unique properties such as a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. It has been studied in 448 participants across six completed clinical trials, which included patients with autoimmune disorders like rheumatoid arthritis, Crohn’s disease, and systemic lupus erythematosus. These studies, along with pharmacokinetic and pharmacodynamic modeling, have guided the dosing regimens being tested in the TRANQUILITY trial.

Tourmaline Bio is committed to developing transformative medicines aimed at significantly improving the lives of patients with severe immune and inflammatory diseases. TOUR006, the company's leading asset, is currently being developed for indications including thyroid eye disease and atherosclerotic cardiovascular disease, with additional potential applications under consideration.

The TRANQUILITY study is a pivotal step in advancing TOUR006 toward Phase 3 readiness for treating ASCVD and other cardiovascular conditions. The outcomes from this trial could pave the way for new therapeutic approaches for patients with chronic kidney disease and elevated cardiovascular risk.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!