Tourmaline Bio posts mid-stage data for anti-inflammatory agent

Shares of Tourmaline Bio (NASDAQ:TRML) fell in the premarket on Tuesday after the company posted topline data from a mid-stage trial for its lead candidate, pacibekitug, in patients with elevated high-sensitivity C-reactive protein, a biomarker of inflammation in the body.

Citing its ongoing Phase 2 TRANQUILITY trial, the New York-based biotech said that its injectable over 90 days at quarterly and monthly dosing led to fast, sustainable, and sizable reductions of hs-CRP with high statistical significance compared to placebo.

With high hs-CRP levels being linked to elevated cardiovascular risk and chronic kidney disease (CKD), the 143-subject trial was designed to evaluate pacibekitug in patients with elevated hs-CRP and CKD.

As for tolerability, 10% and 54% in the pacibekitug group experienced any serious adverse event or any adverse event, respectively, compared to 11% and 56% in the placebo group. There was one mortality: a patient in the 25 mg quarterly arm who died following COVID-19.

The company said TRANQUILITY results would support pacibekitug’s advancement into a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease (ASCVD) and a Phase 2 proof-of-concept trial in abdominal aortic aneurysm (AAA). An update on the cardiovascular outcomes trial in ASCVD is expected later this year, and the AAA trial is scheduled to begin in H2 2025.