Tourmaline Bio Presents Data from the Ongoing Phase 2 TRANQUILITY Trial at the 2025 European Society of Cardiology Congress
Tourmaline Bio (NASDAQ: TRML) presented additional data from its Phase 2 TRANQUILITY trial of pacibekitug at the ESC Congress 2025. The trial demonstrated significant results in treating patients with elevated hs-CRP and chronic kidney disease.
The data showed consistent reductions in high-sensitivity C-reactive protein (hs-CRP) across various patient subgroups. Notably, pacibekitug achieved >85% hs-CRP reductions in the 50mg quarterly dosing arm, becoming the first IL-6 inhibitor to demonstrate such efficacy with quarterly dosing. The drug also showed statistically significant reductions in secondary biomarkers including lipoprotein(a), fibrinogen, and serum amyloid A.
Based on these positive results, Tourmaline 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 ASCVD patients.
Tourmaline Bio (NASDAQ: TRML) ha presentato dati aggiuntivi dal suo studio di Fase 2 TRANQUILITY su pacibekitug al Congresso ESC 2025. Lo studio ha mostrato risultati significativi nel trattamento di pazienti con hs-CRP elevato e malattia renale cronica.
I dati hanno evidenziato riduzioni costanti della proteina C-reattiva ad alta sensibilit脿 (hs-CRP) in diversi sottogruppi di pazienti. In particolare, pacibekitug ha raggiunto >85% di riduzione dell'hs-CRP con il dosaggio di 50 mg somministrato trimestralmente, diventando il primo inibitore dell'IL-6 a dimostrare tale efficacia con somministrazione trimestrale. Il farmaco ha mostrato inoltre riduzioni statisticamente significative in biomarcatori secondari quali lipoproteina(a), fibrinogeno e amiloide sierica A.
Sulla base di questi risultati positivi, Tourmaline prevede di avviare uno studio di proof-of-concept di Fase 2 nell'aneurisma dell'aorta addominale (AAA) e di proseguire i preparativi per uno studio di Fase 3 sugli esiti cardiovascolari nei pazienti con ASCVD.
Tourmaline Bio (NASDAQ: TRML) present贸 datos adicionales de su ensayo de Fase 2 TRANQUILITY con pacibekitug en el Congreso ESC 2025. El ensayo demostr贸 resultados significativos en el tratamiento de pacientes con hs-CRP elevado y enfermedad renal cr贸nica.
Los datos mostraron reducciones consistentes de la prote铆na C reactiva de alta sensibilidad (hs-CRP) en varios subgrupos de pacientes. En concreto, pacibekitug alcanz贸 >85% de reducci贸n de hs-CRP en el brazo de dosificaci贸n trimestral de 50 mg, convirti茅ndose en el primer inhibidor de IL-6 en demostrar tal eficacia con dosificaci贸n trimestral. El f谩rmaco tambi茅n mostr贸 reducciones estad铆sticamente significativas en biomarcadores secundarios como lipoprote铆na(a), fibrin贸geno y amiloide s茅rica A.
Bas谩ndose en estos resultados positivos, Tourmaline planea iniciar un estudio de prueba de concepto de Fase 2 en aneurisma de la aorta abdominal (AAA) y continuar los preparativos para un ensayo de resultados cardiovasculares de Fase 3 en pacientes con ASCVD.
Tourmaline Bio (NASDAQ: TRML)電� ESC Congress 2025鞐愳劀 pacibekitug鞚� 2靸� TRANQUILITY 鞁滍棙 於旉皜 雿办澊韯半ゼ 氚滍憸頄堨姷雼堧嫟. 頃措嫻 鞁滍棙鞚� 瓿犼皭霃� C-氚橃潙靹彪嫧氚膘(hs-CRP) 靸侅姽 氚� 毵岇劚 鞁犾頇� 頇橃瀽 旃橂鞐愳劀 鞙犾潣氙疙暅 瓴瓣臣毳� 氤挫榾鞀惦媹雼�.
雿办澊韯半姅 雼れ枒頃� 頇橃瀽 頃橃渼甑办棎靹� 瓿犼皭霃� C-氚橃潙靹彪嫧氚膘(hs-CRP)鞚� 鞚缄磤霅� 臧愳唽毳� 雮橅儉雰堨姷雼堧嫟. 韸鬼瀳 pacibekitug電� 攵勱赴氤� 50mg 韴棳甑办棎靹� hs-CRP毳� >85% 臧愳唽鞁滌紲 攵勱赴氤� 韴棳搿� 鞚措煬頃� 須姤鞚� 鞛呾頃� 斓滌磮鞚� IL-6 鞏奠牅鞝滉皜 霅橃棃鞀惦媹雼�. 鞚� 鞎诫鞚� 霕愴暅 歆�歆堧嫧氚膘(a), 靹湢靻岇洂, 順堨箔 鞎勲皜搿滌澊霌� A 霌� 2彀� 氚旍澊鞓る旎れ棎靹滊弰 韱店硠鞝侅溂搿� 鞙犾潣頃� 臧愳唽毳� 氤挫榾鞀惦媹雼�.
鞚� 臧欖潃 旮嶌爼鞝� 瓴瓣臣毳� 氚旐儠鞙茧 Tourmaline鞚� 氤惦秬 雽�霃欕Д毳�(AAA)鞐愳劀鞚� 2靸� 臧滊厫 歃濍獏 鞐瓣惮毳� 鞁滌瀾頃橁碃 ASCVD 頇橃瀽 雽�靸侅潣 3靸� 鞁槇甏� 瓴瓣臣 鞁滍棙 欷�牍勲ゼ 瓿勳啀頃� 瓿勴殟鞛呺媹雼�.
Tourmaline Bio (NASDAQ: TRML) a pr茅sent茅 des donn茅es suppl茅mentaires de son essai de phase 2 TRANQUILITY sur pacibekitug au congr猫s ESC 2025. L'essai a d茅montr茅 des r茅sultats significatifs dans le traitement de patients pr茅sentant une hs-CRP 茅lev茅e et une maladie r茅nale chronique.
Les donn茅es ont montr茅 des r茅ductions constantes de la prot茅ine C-r茅active hautement sensible (hs-CRP) dans diff茅rents sous-groupes de patients. Notamment, pacibekitug a obtenu une r茅duction de la hs-CRP >85% dans le bras 脿 50 mg administr茅 trimestriellement, devenant ainsi le premier inhibiteur de l'IL鈥�6 脿 d茅montrer une telle efficacit茅 avec un sch茅ma trimestriel. Le m茅dicament a 茅galement entra卯n茅 des r茅ductions statistiquement significatives de biomarqueurs secondaires tels que la lipoprot茅ine(a), le fibrinog猫ne et l'amylo茂de s茅rique A.
Sur la base de ces r茅sultats positifs, Tourmaline pr茅voit de lancer une 茅tude de preuve de concept de phase 2 sur l'an茅vrisme de l'aorte abdominale (AAA) et de poursuivre les pr茅paratifs pour un essai de phase 3 sur les 茅v茅nements cardiovasculaires chez les patients atteints d'ASCVD.
Tourmaline Bio (NASDAQ: TRML) stellte auf dem ESC Congress 2025 weitere Daten aus der Phase-2-TRANQUILITY-Studie zu pacibekitug vor. Die Studie zeigte signifikante Ergebnisse bei der Behandlung von Patienten mit erh枚htem hs-CRP und chronischer Nierenerkrankung.
Die Daten zeigten konsequente Reduktionen des hochsensitiven C-reaktiven Proteins (hs-CRP) in verschiedenen Patientensubgruppen. Bemerkenswert ist, dass pacibekitug im Quartalsdosisarm mit 50 mg eine >85%ige hs-CRP-Reduktion erreichte und damit der erste IL鈥�6-Inhibitor ist, der eine solche Wirksamkeit bei quartalsweiser Dosierung demonstriert. Das Medikament zeigte au脽erdem statistisch signifikante Reduktionen sekund盲rer Biomarker wie Lipoprotein(a), Fibrinogen und Serum-Amyloid A.
Auf Basis dieser positiven Ergebnisse plant Tourmaline den Start einer Phase鈥�2鈥慞roof鈥憃f鈥慍oncept鈥慡tudie beim abdominellen Aortenaneurysma (AAA) und setzt die Vorbereitungen f眉r eine 笔丑补蝉别鈥�3鈥慔别谤锄-碍谤别颈蝉濒补耻蹿鈥慐苍诲辫耻苍办迟蝉迟耻诲颈别 bei ASCVD鈥慞atienten fort.
- 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
- None.
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<0.0001) in this key inflammatory biomarker through Day 90 across all dosing arms.
What's particularly notable is pacibekitug's quarterly dosing potential 鈥� 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 鈥� 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.
鈥� Poster presentation highlights the consistency of reductions in high-sensitivity C-reactive protein with pacibekitug across clinically-meaningful subgroups聽鈥�
鈥� Pacibekitug demonstrated concordant, statistically significant reductions in secondary pharmacodynamic biomarkers of IL-6 pathway activity including lipoprotein(a), fibrinogen, and serum amyloid A聽鈥�
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鈥檚 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 , and the ESC poster can be accessed .
鈥淎cross 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,鈥� said Dr. Bhatt. 鈥淚mportantly, 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鈥檚 continued evaluation in atherosclerotic cardiovascular disease and other inflammation-driven cardiovascular diseases.鈥�
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 , 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 >
Poster Presentation Details:
Title:听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 鈥� 4:00 pm CEST
Abstract Number: #599
For more information, please visit the ; the poster presentation is also available in the of Tourmaline鈥檚 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 .
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鈥檚 lead asset is pacibekitug. For more information about Tourmaline and pacibekitug, please visit or follow us on , or .
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 鈥渂elieve,鈥� 鈥渄esigned to,鈥� 鈥渆xpect,鈥� 鈥渕ay,鈥� 鈥減lan,鈥� 鈥減otential,鈥� 鈥渨ill鈥� and similar expressions, and are based on Tourmaline鈥檚 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鈥檚 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鈥檚 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鈥檚 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鈥檚 current or future product candidates; the risk that Tourmaline鈥檚 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鈥檚 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鈥檚 business, clinical trials and financial position; and other risks and uncertainties that are described in Tourmaline鈥檚 Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (鈥淪EC鈥�) 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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FAQ
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