Monthly and Quarterly Pacibekitug for Chronic Kidney Disease and High Cardiovascular Risk

“There is strong evidence suggesting that elevated levels of high-sensitivity C-reaction protein (hs-CRP) are a predictor of increased cardiovascular risk, and quarterly subcutaneous administration of pacibekitug in the TRANQUILITY trial demonstrated large and significant reductions in hs-CRP levels through Day 90. Based upon these results, pacibekitug merits testing in future Phase 3 trials for cardiovascular risk reduction.”

“Across all monthly and quarterly dosing arms, subcutaneously administered pacibekitug demonstrated rapid, deep, and consistent reductions in hs-CRP, a well-established biomarker of residual inflammatory risk. Importantly, reductions in hs-CRP were consistently achieved across a wide range of clinically relevant subgroups, including sex, body mass index, presence or absence of diabetes, baseline GLP-1 and GIP/GLP-1 receptor agonist use, and baseline hs-CRP level. Together, these data make a strong case for pacibekitug's continued evaluation in atherosclerotic cardiovascular disease and other inflammation-driven cardiovascular diseases.”

“We are thrilled with the data emerging from the TRANQUILITY trial and the remarkable consistency of signal across all endpoints evaluated. All active arms achieved rapid, deep, and durable reductions in hs-CRP, and overall incidence rates of adverse events and serious adverse events were comparable between pacibekitug and placebo. Importantly, this is the first time that pacibekitug or any IL-6 inhibitor has been tested in a clinical trial with quarterly dosing. It is well-recognized that less frequent administration has the potential to enhance patient adherence and ultimate clinical benefit.”