- Tourmaline Bio (TRML, Financial) announces positive results from the Phase 2 TRANQUILITY trial.
- Pacibekitug demonstrated significant reductions in hs-CRP with quarterly dosing.
- The trial supports moving forward to Phase 3 trials for cardiovascular treatments.
Tourmaline Bio, Inc. (NASDAQ: TRML), a late-stage clinical biotechnology company, reported promising topline results from its ongoing Phase 2 TRANQUILITY trial. The trial evaluated pacibekitug, a long-acting, anti-IL-6 monoclonal antibody, for patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD).
All tested doses of pacibekitug showcased rapid, deep, and durable reductions in hs-CRP through Day 90 compared to placebo, achieving statistical significance (p<0.0001). Notably, the 50 mg quarterly dose achieved more than 85% reduction in hs-CRP, marking pacibekitug as the first IL-6 inhibitor to achieve such results with quarterly dosing.
Furthermore, the safety profile of pacibekitug was comparable to placebo, with adverse events recorded at 54% for the treatment group and 56% for the placebo group. A single COVID-19 related death was reported in the 25 mg quarterly arm, with no significant safety concerns detected.
Tourmaline plans to advance pacibekitug into a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD) and initiate a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA) in the second half of 2025.
The results underscore pacibekitug's potential to serve as a quarterly dosing option for reducing inflammatory markers in cardiovascular and other conditions, aligning with Tourmaline's commitment to transforming patient treatment.
