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Pacibekitug Cuts hs-CRP by Up to 89% in Phase II Kidney Disease Trial

Durable IL-6 suppression was achieved with infrequent dosing that needs confirmation of clinical benefit in larger phase III trials.

Overview

  • Final six-month TRANQUILITY data presented at ESC Congress on August 29, 2026 showed dose-dependent, sustained reductions in high-sensitivity C-reactive protein with median time-averaged changes of +7% for placebo and −76% to −89% across pacibekitug arms.
  • TRANQUILITY was a randomized, double-blind, placebo-controlled phase II study run at 49 U.S. centers that enrolled 143 adults with stage 3–4 chronic kidney disease and elevated hs-CRP and tested three dosing regimens versus placebo over 180 days.
  • Pacibekitug, an investigational long-acting monoclonal antibody targeting interleukin-6, also produced favorable changes in other inflammation-related markers including fibrinogen and lipoprotein(a).
  • The drug was generally well tolerated through six months with about 1.9% trial discontinuations and no new or dose-related safety signals identified in this phase II experience.
  • Study authors and sponsor Tourmaline Bio (a Novartis company) said the findings support moving to larger, longer phase III outcome trials to see if the biomarker drops translate into fewer cardiovascular events and investigators disclosed advisory and funding ties to the sponsor.