Tourmaline Bio (NASDAQ: TRML) unveiled fresh data from its Phase 2 TRANQUILITY trial of pacibekitug at the ESC Congress 2025, sending ripples of optimism through the biotech sector. The trial showcased compelling results in patients battling elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease, potentially opening new avenues for treatment.
The data revealed consistent declines in hs-CRP across a diverse range of patient subgroups, a signal of pacibekitug’s broad applicability. The drug particularly shined in the 50mg quarterly dosing arm, achieving greater than 85% reduction in hs-CRP, making it the first IL-6 inhibitor to deliver such efficacy with a quarterly regimen. Beyond hs-CRP, pacibekitug also demonstrated statistically significant reductions in secondary biomarkers linked to cardiovascular risk, including lipoprotein(a), fibrinogen, and serum amyloid A.
Fueled by these promising results, Tourmaline Bio is gearing up for a Phase 2 proof-of-concept study targeting abdominal aortic aneurysm (AAA). Simultaneously, the company is laying the groundwork for a Phase 3 cardiovascular outcomes trial focusing on patients with atherosclerotic cardiovascular disease (ASCVD).
Positive
Achieved >85% hs-CRP reductions from baseline in 50mg quarterly dosing arm
First IL-6 inhibitor to demonstrate deep hs-CRP reductions with quarterly dosing
Statistically significant reductions in multiple cardiovascular risk biomarkers
Consistent efficacy across various patient subgroups
Advancing to Phase 2 AAA study and Phase 3 cardiovascular outcomes trial
Insights
Tourmaline’s pacibekitug shows consistent, significant inflammatory biomarker reductions across patient subgroups, supporting advancement to Phase 3 cardiovascular trials.
Tourmaline Bio’s Phase 2 TRANQUILITY trial results demonstrate pacibekitug, their long-acting anti-IL-6 antibody, achieved consistent reductions in high-sensitivity C-reactive protein (hs-CRP) across multiple patient subgroups. The data showed statistically significant reductions (p
What’s particularly notable is pacibekitug’s quarterly dosing potential – the 50mg quarterly dose achieved >85% hs-CRP reduction from baseline, making it the first IL-6 inhibitor to demonstrate such efficacy with infrequent dosing. This could represent a significant competitive advantage in treatment compliance and convenience.
The drug also demonstrated concordant reductions in secondary biomarkers, including lipoprotein(a), fibrinogen, and serum amyloid A – all associated with cardiovascular risk. These reductions were statistically significant across multiple dose arms, providing mechanistic confirmation of pacibekitug’s anti-inflammatory effects.
The consistent efficacy across subgroups including sex, BMI, diabetes status, and concomitant GLP-1 therapy use indicates broad applicability. Based on these positive results, Tourmaline plans to advance pacibekitug to a Phase 2 proof-of-concept study in abdominal aortic aneurysm and is preparing for a Phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease patients.
This progress positions Tourmaline to potentially address significant unmet needs in inflammation-driven cardiovascular diseases, representing an important advancement in their clinical pipeline.
08/31/2025 – 10:23 AM
– Poster presentation highlights the consistency of reductions in high-sensitivity C-reactive protein with pacibekitug across clinically-meaningful subgroups –
– Pacibekitug demonstrated concordant, statistically significant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity including lipoprotein(a), fibrinogen, and serum amyloid A –
What were the key findings of Tourmaline Bio’s (TRML) TRANQUILITY Phase 2 trial?
The trial showed >85% hs-CRP reductions in the 50mg quarterly dosing arm, with statistically significant reductions in biomarkers including lipoprotein(a), fibrinogen, and serum amyloid A. Pacibekitug became the first IL-6 inhibitor to achieve such results with quarterly dosing.
How did pacibekitug perform across different patient subgroups in the TRANQUILITY trial?
Pacibekitug demonstrated consistent reductions in hs-CRP across various subgroups, including differences in sex, body mass index, diabetes status, baseline GLP-1 and GIP/GLP-1 receptor agonist use, and baseline hs-CRP level.
What are Tourmaline Bio’s (TRML) next steps following the TRANQUILITY trial results?
Tourmaline Bio plans to initiate a Phase 2 proof-of-concept study in abdominal aortic aneurysm (AAA) and continue preparations for a Phase 3 cardiovascular outcomes trial in patients with atherosclerotic cardiovascular disease (ASCVD).
What biomarkers were reduced in the TRANQUILITY trial of pacibekitug?
The trial showed significant reductions in multiple biomarkers including high-sensitivity C-reactive protein (hs-CRP), lipoprotein(a), fibrinogen, and serum amyloid A, all associated with cardiovascular risk.
When were the TRANQUILITY trial results presented by Tourmaline Bio (TRML)?
The results were presented at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain, on August 31, 2025, with the topline results previously reported in May 2025.
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