Tourmaline Bio Starts Phase 2 Trial of TOUR006 for Cardiovascular Diseases

Tourmaline Bio Inc. (Tourmaline), a late-stage clinical biotechnology firm focused on developing transformative treatments for severe immune and inflammatory disorders, has initiated its Phase 2 TRANQUILITY trial. This trial marks the first patient receiving a dose of TOUR006, a long-acting, fully human, anti-IL-6 monoclonal antibody intended to treat atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular conditions. The TRANQUILITY trial is a randomized, double-blind, placebo-controlled study targeting patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD).

Emil deGoma, MD, Senior VP of Medical Research at Tourmaline and former Medical Director of the Preventive Cardiovascular Program at the University of Pennsylvania, highlighted the urgency of new treatments for patients at high risk of severe cardiovascular events such as heart attack, stroke, and acute limb ischemia. He emphasized the therapeutic potential of IL-6 inhibition, supported by various human genetic studies, epidemiological data, and clinical trials.

The TRANQUILITY trial’s design is informed by six previous Phase 1 and Phase 2 studies of TOUR006. If successful, the Phase 2 results could set the stage for a Phase 3 trial in 2025, focusing on ASCVD and other cardiovascular ailments.

Sandeep Kulkarni, MD, Co-Founder and CEO of Tourmaline, described TOUR006 as a "pipelines in a product" opportunity, targeting critical cardiovascular diseases driven by IL-6 inflammation and serious autoimmune disorders such as thyroid eye disease. Kulkarni expressed confidence in TOUR006’s potential to become a best-in-class treatment, citing its possible quarterly dosing schedule, which could enhance patient adherence and ease of use. The company anticipates sharing topline results from the TRANQUILITY trial in the first half of 2025.

The Phase 2 TRANQUILITY trial aims to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of quarterly and monthly subcutaneous doses of TOUR006 in patients with high hs-CRP levels and CKD. The study design includes insights from prior clinical trials involving TOUR006 on healthy volunteers and patients with autoimmune disorders like rheumatoid arthritis, Crohn’s disease, and systemic lupus erythematosus, as well as PK/PD modeling.

TOUR006 stands out due to its long half-life, low immunogenicity, and high binding affinity to IL-6. Previously, the drug has been tested in 448 participants, including those with autoimmune conditions, across six completed clinical trials. Tourmaline is currently advancing TOUR006 for thyroid eye disease and ASCVD, with further applications under evaluation.

Tourmaline Bio is a dedicated clinical-stage biotechnology company focused on developing innovative medicines to significantly improve the lives of patients suffering from severe immune and inflammatory diseases. TOUR006 is their leading asset in this mission.

The Phase 2 TRANQUILITY trial represents a critical step in the clinical development of TOUR006. With promising results, Tourmaline could be well-prepared for Phase 3 trials by 2025, potentially offering a new, effective treatment for patients with ASCVD and other cardiovascular conditions.