Tourmaline Bio, Inc. (NASDAQ: TRML) has released positive topline results from its ongoing phase 2 tranquility trial evaluating quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity c-reactive protein (hs-crp) and chronic kidney disease (CKD). The trial demonstrated rapid, deep, and durable reductions in hs-crp across all pacibekitug arms, with high statistical significance compared to placebo (p<0.0001 for all arms).
The results showed that pacibekitug became the first IL-6 inhibitor known to demonstrate deep hs-crp reductions with quarterly dosing in a clinical trial, achieving over 85% hs-crp reductions from baseline in the 50 mg quarterly arm. The overall incidence rates of adverse events and serious adverse events in the pacibekitug groups were comparable to placebo through the data extract date.
Key pharmacodynamic data for the primary analysis population showed significant changes from baseline in hs-crp levels, with the 50 mg quarterly arm achieving an 86% median time-averaged percent reduction in hs-crp through day 90. Additionally, the percentage of participants achieving time-averaged hs-crp below 2 mg/l through day 90 was 80% in the 50 mg quarterly arm.
The safety data revealed that the cumulative incidence of any adverse event was 54% in the pooled pacibekitug group, compared with 56% in the placebo group. The most common adverse events in the pacibekitug group were urinary tract infection (4%), COVID-19 (3%), dizziness (3%), and viral upper respiratory tract infection (3%). The overall incidence of any serious adverse event was 10% in the pooled pacibekitug group versus 11% in the placebo group.
Looking ahead, Tourmaline plans to advance the development of pacibekitug into potential phase 3 cardiovascular outcomes trials in atherosclerotic cardiovascular disease and a planned phase 2 proof-of-concept trial in abdominal aortic aneurysm. The company also aims to provide further information on a potential phase 3 cardiovascular outcomes trial in atherosclerotic cardiovascular disease later in 2025 following discussions with regulatory authorities.
The company also plans to initiate a phase 2 proof-of-concept trial in patients with abdominal aortic aneurysm in the second half of 2025. The therapeutic potential of IL-6 inhibition for the treatment of abdominal aortic aneurysm is supported by human genetic studies, epidemiological evidence, and mouse models of the condition.
In a statement, Dr. Sandeep Kulkarni, co-founder and CEO of Tourmaline, expressed excitement about the data emerging from the tranquility trial and the potential for pacibekitug to enhance patient adherence and ultimate clinical benefit.
The company will host a live conference call and webcast to discuss these results today, May 20, 2025.
The press release did not provide specific figures comparing the current results to the previous period. The market has reacted to these announcements by moving the company's shares 2.89% to a price of $17.11. Check out the company's full 8-K submission here.
