Tourmaline Bio has unveiled the design of its Phase II TRANQUILITY study, which is set to explore TOUR006 in reducing high-sensitivity C-reactive protein (hs-CRP) levels in patients with chronic kidney disease (CKD).
The study aims to address the cardiovascular risks associated with elevated hs-CRP, a key biomarker of inflammation.
Previously, TOUR006 has shown potential in lowering hs-CRP levels in patients with various inflammatory autoimmune diseases.
The randomised, double-blind, placebo-controlled, multicentre trial will involve around 120 patients with stage 3 or 4 CKD and hs-CRP levels between 2mg/L and 15mg/L.
It will assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TOUR006, including its CRP-lowering effect, through quarterly and monthly subcutaneous administration in patients with elevated hs-CRP and CKD.
The dosing regimens for the study were informed by the outcomes of six previous Phase I and Phase II trials involving healthy volunteers and patients with rheumatoid arthritis, Crohn’s disease, or systemic lupus erythematosus, as well as PK/PD modelling.
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By GlobalDataThe primary objective of the TRANQUILITY trial is to evaluate the hs-CRP-lowering effect, safety, tolerability, and pharmacokinetics of TOUR006 in this patient population.
Participants will be stratified by CKD stage and randomised to receive subcutaneous TOUR006 at doses of 50mg quarterly, 25mg quarterly, 15mg monthly, or a placebo.
The primary pharmacodynamic endpoint is the change in hs-CRP levels from baseline.
This study will also measure additional biomarkers, including IL-6, lipoprotein(a), oxidized low-density lipoprotein (LDL), and fibrinogen.
The treatment and follow-up periods are set at 180 days and 185 days, respectively, with the primary completion of the study expected in May 2025.
Tourmaline Bio medical research senior vice-president Emil deGoma said: “The TRANQUILITY study represents an important step in understanding the potential of TOUR006 to address unmet needs in patients with residual inflammatory cardiovascular risk, despite lifestyle changes and available therapeutic interventions.
“With a robust clinical dataset from six previous trials involving 448 dosed study participants, comprised of healthy volunteers and patients with diseases other than cardiovascular disorders, as well as converging clinical evidence supporting the therapeutic potential of IL-6 inhibition, we are confident in our approach and the potential of TOUR006 and look forward to seeing the data from this study.”
