Tourmaline Bio has dosed the first patient in its Phase 2 TRANQUILITY trial for TOUR006, an anti-IL-6 monoclonal antibody aimed at treating atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular conditions. The randomized, double-blind study will assess the safety and efficacy of TOUR006 in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease, with results from the trial expected in early 2025, positioning the therapy for Phase 3 readiness.

The following article originally appeared in Drug Development & Delivery.

Tourmaline Bio, Inc. recently announced the first patient has been dosed in its Phase 2 TRANQUILITY trial, marking the initiation of its clinical development program for TOUR006, a long-acting, fully human, anti-IL-6 monoclonal antibody, for the treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. TRANQUILITY is a randomized, double-blind, placebo-controlled trial enrolling patients with inflammatory risk, manifesting as elevated high-sensitivity C-reactive protein (hs-CRP) at baseline, and chronic kidney disease (CKD).

“New treatments are sorely needed for the millions of patients who remain at very high risk of heart attack, stroke, acute limb ischemia, and death despite traditional risk factor modification,” said Emil deGoma, MD, Senior Vice President of Medical Research at Tourmaline and former Medical Director of the Preventive Cardiovascular Program at the University of Pennsylvania. “Converging evidence from IL-6 human genetic studies, epidemiological studies, and mechanistic experiments as well as analyses from clinical trials of upstream IL-6 inhibition supports the therapeutic potential of IL-6 inhibition for patients across the spectrum of ASCVD as well as for patients with other cardiovascular diseases, including heart failure.”

The design of the TRANQUILITY clinical trial was informed by insights from six prior Phase 1 and Phase 2 studies of TOUR006. If successful, results from the Phase 2 TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready in 2025 for ASCVD and other cardiovascular diseases.

“TOUR006 is a true ‘pipelines in a product’ opportunity, seeking to address both serious cardiovascular diseases for which IL-6-driven inflammation plays a key role as well as serious autoimmune disorders, such as thyroid eye disease,” continued Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline. “We believe TRANQUILITY can showcase TOUR006’s potential as a best-in-class treatment in these indications, offering ease of use and enabling consistent patient adherence, thanks to a potential quarterly dosing schedule. We look forward to sharing topline results from TRANQUILITY in the first half of 2025.”

The Phase 2 TRANQUILITY trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), including CRP-lowering effect, of quarterly and monthly subcutaneous administration of TOUR006 in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). The selection of dosing regimens being evaluated in TRANQUILITY was informed by six previously completed Phase 1 and Phase 2 trials of TOUR006 in healthy volunteers and patients with rheumatoid arthritis, Crohn’s disease, or systemic lupus erythematosus as well as PK/PD modeling. For more information on the TRANQUILITY clinical trial, please visit clinicaltrials.gov (NCT06362759).

TOUR006 is a long-acting, fully human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. TOUR006 has been previously studied in 448 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is developing TOUR006 in thyroid eye disease and atherosclerotic cardiovascular disease as its first two indications, with additional diseases under consideration.

Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is TOUR006.

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