Summary of Tourmaline Bio's Phase II TRANQUILITY Trial Conference Call Company and Industry - **Company**: Tourmaline Bio - **Industry**: Cardiovascular Medicine, specifically focusing on anti-inflammatory treatments for cardiovascular diseases Core Points and Arguments 1. **Trial Overview**: The TRANQUILITY trial is a Phase II study evaluating pacifecatug, an IL-6 inhibitor, aimed at reducing high sensitivity C-reactive protein (hsCRP), a biomarker for inflammation-related cardiovascular risk [5][6][7] 2. **Objectives**: The trial has three main objectives: - To test the efficacy of quarterly administration of an IL-6 inhibitor in reducing hsCRP levels - To gather safety data for Phase III development - To confirm the appropriate dosing for future studies [5][6] 3. **Results**: - Statistically significant reductions in hsCRP were observed across all dosing arms compared to placebo, with reductions of 75% for the 25 mg quarterly arm, 86% for the 50 mg quarterly arm, and 85% for the 15 mg monthly arm [18][19] - A significant percentage of patients achieved hsCRP levels below 2 mg/L, indicating reduced inflammatory risk: 81% in the 25 mg arm, 80% in the 50 mg arm, and 88% in the 15 mg arm [21][22] 4. **Safety Profile**: Pacifecatug was well tolerated, with adverse event rates comparable to placebo. No significant safety concerns were raised, and the incidence of serious adverse events was low [30][31] 5. **Unmet Need**: Cardiovascular disease remains a leading cause of morbidity and mortality, with a significant portion of patients experiencing inflammation that is not adequately addressed by current therapies [7][8] 6. **Future Directions**: - Plans to meet with the FDA to discuss Phase III trial design and confirm dosing strategy - Potential Phase II proof of concept study in abdominal aortic aneurysm (AAA) [43][43] - Exploration of longer dosing intervals, including potential six-month dosing [80][82] Additional Important Content 1. **Context of Inflammation**: The trial highlights the role of inflammation in cardiovascular disease, with hsCRP serving as a key marker. The evidence supporting IL-6 as a modifiable risk factor is growing, with genetic, epidemiological, and clinical trial data backing its significance [9][37] 2. **Placebo Response**: Variability in placebo responses was noted, consistent with other IL-6 inhibitor trials. The active treatment arms showed significant reductions in hsCRP, suggesting that the observed effects are not solely due to placebo [68][72] 3. **Regulatory Strategy**: The company aims to leverage existing data to support its regulatory submissions and is focused on high-risk patient populations that are currently underserved [41][61] This summary encapsulates the key findings and strategic directions from the conference call regarding Tourmaline Bio's ongoing efforts in cardiovascular treatment development.