Tourmaline Bio Presents Data from the Ongoing Phase 2 TRANQUILITY Trial at the 2025 European Society of Cardiology Congress
– 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 –
NEW YORK, Aug. 31, 2025 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ:TRML), a late-stage clinical biotechnology company developing transformative medicines that establish new standards of care for patients with life-altering inflammatory and immune diseases, today presented additional data from its ongoing Phase 2 TRANQUILITY trial of pacibekitug in a poster presentation at the European Society of Cardiology (ESC) Congress 2025 in Madrid, Spain, highlighting the consistency of reduction in high-sensitivity C-reactive protein (hs-CRP) with pacibekitug across a wide range of subgroups as well as concordant reductions in key biomarkers beyond hs-CRP, including lipoprotein(a), fibrinogen, and serum amyloid A.
The poster, presented by Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital, the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York, and Chair of Tourmaline's Cardiovascular Scientific Advisory Board (for which he is compensated), highlights additional data from TRANQUILITY, a randomized, placebo-controlled trial evaluating pacibekitug, a long-acting anti-IL-6 monoclonal antibody, in patients with elevated hs-CRP and chronic kidney disease (CKD). These more complete data are from the same April 23, 2025, data extract as the topline results previously reported by Tourmaline in May 2025. The May 2025 topline results press release can be accessed here, and the ESC poster can be accessed here.
"Across all monthly and quarterly dosing arms, subcutaneously administered pacibekitug demonstrated rapid, deep, and consistent reductions in hs-CRP, a well-established biomarker of residual inflammatory risk," said Dr. Bhatt. "Importantly, reductions in hs-CRP were consistently achieved across a wide range of clinically relevant subgroups, including sex, body mass index, presence or absence of diabetes, baseline GLP-1 and GIP/GLP-1 receptor agonist use, and baseline hs-CRP level. Together, these data make a strong case for pacibekitug's continued evaluation in atherosclerotic cardiovascular disease and other inflammation-driven cardiovascular diseases."
As previously reported in May 2025, rapid, deep, and durable reductions in hs-CRP through Day 90 were achieved across all pacibekitug arms with a high degree of statistical significance as compared to placebo (p<0.0001 for all arms). As outlined in the ESC poster, in addition to reducing hs-CRP, pacibekitug also demonstrated reductions in lipoprotein(a), fibrinogen, and serum amyloid A, biomarkers of IL-6 pathway activity also associated with cardiovascular risk. The reductions in fibrinogen and serum amyloid A were statistically significant in all three pacibekitug dose arms and the reductions in lipoprotein(a) were statistically significant in the 50mg quarterly and 15mg monthly arms.
Based on these results, pacibekitug became the first and only IL-6 inhibitor known to demonstrate deep hs-CRP reductions with quarterly dosing in a clinical trial, achieving >85% hs-CRP reductions from baseline in the 50 mg quarterly arm. These results support Tourmaline's plans to initiate a Phase 2 proof-of-concept study in abdominal aortic aneurysm (AAA) and to continue its preparations for a Phase 3 cardiovascular outcomes trial in patients with atherosclerotic cardiovascular disease (ASCVD).
Poster Presentation Details:
Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Ph2 Trial of Pacibekitug SC Quarterly or Monthly in Patients with Elevated hs-CRP and Chronic Kidney Disease: TRANQUILITY 90-Day Results
Authors: PE. Pergola1, E. Degoma2, F. Hemani2, J. Walsh2, H. Zayed2, PM. Ridker3, M. Szarek4, DL. Bhatt4
Affiliations:
1Renal Associates, P.A., San Antonio, USA
2Tourmaline Bio, Inc., New York, USA
3Brigham and Women's Hospital, Harvard Medical School, USA
4Icahn School of Medicine at Mount Sinai, New York, USA
Date and Time: August 31, 2025, 3:15 – 4:00 pm CEST
Abstract Number: #599
For more information, please visit the ESC Congress website; the poster presentation is also available in the Publications section of Tourmaline's website.
About the TRANQUILITY Trial:
TRANQUILITY is a multicenter, randomized, double-blind, placebo-controlled Phase 2 trial evaluating pacibekitug in patients with elevated hs-CRP, a key inflammatory biomarker associated with elevated cardiovascular risk, and chronic kidney disease. The primary endpoint of the TRANQUILITY trial is median time-averaged percent change in hs-CRP through Day 90. The key secondary endpoint is the percentage of participants achieving time-averaged hs-CRP below 2 mg/L through Day 90. Additional information on the TRANQUILITY trial can be found here.
About Pacibekitug:
Pacibekitug is a long-acting, fully-human, anti-IL-6 monoclonal antibody with best-in-class potential and differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. Pacibekitug has been previously studied in approximately 450 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is currently developing pacibekitug in atherosclerotic cardiovascular disease (ASCVD) and thyroid eye disease (TED) as its first two indications, with plans to expand into abdominal aortic aneurysm (AAA) and additional diseases in the future.
About Tourmaline Bio:
Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that establish new standards of care for patients with life-altering inflammatory and immune diseases. Tourmaline's lead asset is pacibekitug. For more information about Tourmaline and pacibekitug, please visit https://www.tourmalinebio.com or follow us on LinkedIn, X or Bluesky.
Cautionary Note Regarding Forward-Looking Statements:
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "believe," "designed to," "expect," "may," "plan," "potential," "will" and similar expressions, and are based on Tourmaline's current beliefs and expectations. These forward-looking statements include expectations regarding the development and potential therapeutic benefits of pacibekitug; the timing of initiation, progress and results of Tourmaline's current and future clinical trials for pacibekitug, including reporting of data therefrom; Phase 3 clinical trial readiness; and the potential to expand pacibekitug into additional indications. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the development of therapeutic product candidates, such as the risk that any one or more of Tourmaline's current or future product candidates will not be successfully developed or commercialized; the risk of delay or cessation of any planned clinical trials of Tourmaline's current or future product candidates; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Tourmaline's current or future product candidates; the risk that Tourmaline's current or future product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that Tourmaline anticipates; risks regarding the accuracy of Tourmaline's estimates of expenses, capital requirements and needs for additional financing; changes in expected or existing competition; changes in the regulatory environment; the uncertainties and timing of the regulatory approval process; unexpected litigation or other disputes; the impacts of macroeconomic conditions Tourmaline's business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline's Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission ("SEC") on August 13, 2025 and other filings that Tourmaline makes with the SEC from time to time. Any forward-looking statements speak only as of the date of this press release and are based on information available to Tourmaline as of the date hereof, and Tourmaline assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
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