Tourmaline Bio Presents Phase 2 TRANQUILITY Study Design at American Society of Preventive Cardiology (ASPC) Congress 2024
Tourmaline Bio (NASDAQ: TRML) presented the design of its Phase 2 TRANQUILITY study at the American Society of Preventive Cardiology Congress 2024. The study evaluates TOUR006's ability to reduce high-sensitivity C-reactive protein (hs-CRP) in patients with chronic kidney disease (CKD) and elevated hs-CRP, who are at higher risk of atherosclerotic cardiovascular disease (ASCVD).
The trial involves 120 patients with CKD stage 3 or 4 and hs-CRP ≥2 and <15 mg/L, randomized to receive subcutaneous TOUR006 at various doses or placebo. The primary endpoint is the change in hs-CRP levels. Topline data is expected in the first half of 2025, potentially advancing TOUR006 toward Phase 3 readiness for ASCVD and other cardiovascular diseases.
Tourmaline Bio (NASDAQ: TRML) ha presentato il progetto del suo studio TRANQUILITY di Fase 2 durante il Congresso della Società Americana di Cardiologia Preventiva 2024. Lo studio valuta la capacità del TOUR006 di ridurre la proteina C-reattiva ad alta sensibilità (hs-CRP) in pazienti con insufficienza renale cronica (IRC) e hs-CRP elevato, che sono a maggior rischio di malattia cardiovascolare aterosclerotica (ASCVD).
Il trial coinvolge 120 pazienti con IRC di stadio 3 o 4 e hs-CRP ≥2 e <15 mg/L, randomizzati per ricevere TOUR006 sottocutaneo a varie dosi o placebo. L'endpoint primario è la variazione dei livelli di hs-CRP. I dati preliminari sono attesi nella prima metà del 2025, potenzialmente portando TOUR006 verso la preparazione per la Fase 3 per ASCVD e altre malattie cardiovascolari.
Tourmaline Bio (NASDAQ: TRML) presentó el diseño de su estudio TRANQUILITY de Fase 2 en el Congreso de la Sociedad Americana de Cardiología Preventiva 2024. El estudio evalúa la capacidad del TOUR006 para reducir la proteína C-reactiva de alta sensibilidad (hs-CRP) en pacientes con enfermedad renal crónica (ERC) y hs-CRP elevado, quienes están en mayor riesgo de enfermedad cardiovascular aterosclerótica (ASCVD).
El ensayo involucra 120 pacientes con ERC en estadio 3 o 4 y hs-CRP ≥2 y <15 mg/L, randomizados para recibir TOUR006 por vía subcutánea a diversas dosis o placebo. El objetivo principal es el cambio en los niveles de hs-CRP. Se espera que los datos generales estén disponibles en la primera mitad de 2025, lo que podría avanzar a TOUR006 hacia la preparación de Fase 3 para ASCVD y otras enfermedades cardiovasculares.
투르말린 바이오(Tourmaline Bio, NASDAQ: TRML)는 2024년 미국 예방 심장학회에서 2상 TRANQUILITY 연구의 설계를 발표했습니다. 이 연구는 고감도 C-반응성 단백질(hs-CRP)을 감소시키는 TOUR006의 능력을 만성 신장 질환(CKD) 및 hs-CRP가 상승된 환자에서 평가하며, 이들은 동맥경화성 심혈관 질환(ASCVD)의 높은 위험에 처해 있습니다.
이 임상시험은 CKD 3기 또는 4기에 hs-CRP ≥2 및 <15 mg/L인 120명의 환자를 포함해, 다양한 용량의 TOUR006을 피하 주사 또는 위약을 받도록 무작위 배정됩니다. 주요 평가 지표는 hs-CRP 수치의 변화입니다. 2025년 상반기에 주요 데이터가 기대됩니다, 이는 ASCVD 및 기타 심혈관 질환을 위한 3상 준비로 TOUR006을 진행시킬 수 있습니다.
Tourmaline Bio (NASDAQ: TRML) a présenté la conception de son étude TRANQUILITY de Phase 2 lors du Congrès de la Société Américaine de Cardiologie Préventive 2024. L'étude évalue la capacité de TOUR006 à réduire la protéine C-réactive ultrasensible (hs-CRP) chez les patients atteints de maladie rénale chronique (MRC) et présentant une hs-CRP élevée, qui courent un risque accru de maladie cardiovasculaire athéroscléreuse (ASCVD).
Le procès implique 120 patients atteints de MRC au stade 3 ou 4 et hs-CRP ≥2 et <15 mg/L, randomisés pour recevoir TOUR006 par voie sous-cutanée à diverses doses ou un placebo. Le critère principal est le changement des niveaux de hs-CRP. Les données préliminaires sont attendues au cours de la première moitié de 2025, ce qui pourrait faire progresser TOUR006 vers la préparation de la Phase 3 pour l'ASCVD et d'autres maladies cardiovasculaires.
Tourmaline Bio (NASDAQ: TRML) stellte das Design ihrer Phase 2 TRANQUILITY-Studie auf dem Kongress der American Society of Preventive Cardiology 2024 vor. Die Studie bewertet die Fähigkeit von TOUR006, hoch-sensitives C-reaktives Protein (hs-CRP) bei Patienten mit chronischer Nierenerkrankung (CKD) und erhöhtem hs-CRP zu reduzieren, die ein höheres Risiko für atherosklerotische Herz-Kreislauf-Erkrankungen (ASCVD) haben.
Die Studie umfasst 120 Patienten mit CKD im Stadium 3 oder 4 und hs-CRP ≥2 und <15 mg/L, die randomisiert TOUR006 in verschiedenen Dosen oder ein Placebo erhalten. Der primäre Endpunkt ist die Veränderung der hs-CRP-Werte. Die Gesamtdaten werden in der ersten Hälfte von 2025 erwartet, möglicherweise um TOUR006 auf die Vorbereitung für Phase 3 in Bezug auf ASCVD und andere Herz-Kreislauf-Erkrankungen voranzutreiben.
- TOUR006 has shown promise in reducing hs-CRP levels in patients with inflammatory autoimmune diseases
- The study is supported by data from six previous trials involving 448 dosed participants
- The trial could potentially advance TOUR006 toward Phase 3 readiness for ASCVD and other cardiovascular diseases
- Results from the TRANQUILITY study are not yet available, with topline data expected in the first half of 2025
Insights
The TRANQUILITY Phase 2 study for TOUR006 is a significant step in addressing residual inflammatory cardiovascular risk. Key points:
- Targeting CKD patients with elevated hs-CRP, a high-risk group for ASCVD
- Evaluating multiple dosing regimens (50mg quarterly, 25mg quarterly, 15mg monthly)
- Primary endpoint: change in hs-CRP levels
- Additional biomarkers: IL-6, lipoprotein(a), oxidized LDL, fibrinogen
The study's design, leveraging data from six previous trials, demonstrates a strategic approach to dose optimization. If successful, this could pave the way for a Phase 3 trial in ASCVD, potentially offering a new treatment option for a significant unmet medical need.
The TRANQUILITY study is targeting a important gap in cardiovascular care. Patients with CKD and elevated hs-CRP represent a high-risk population with treatment options. The focus on IL-6 inhibition is well-founded, given its role in inflammation and ASCVD risk. Key considerations:
- Biomarker-driven approach: hs-CRP reduction as primary endpoint is a validated strategy
- Comprehensive biomarker panel: Includes markers of inflammation and lipid oxidation
- Potential for personalized medicine: May help identify patients most likely to benefit from IL-6 inhibition
If TOUR006 demonstrates significant hs-CRP reduction, it could reshape treatment paradigms for residual cardiovascular risk management.
Tourmaline Bio's TRANQUILITY study represents a strategic move into the cardiovascular space, potentially expanding TOUR006's market opportunity. Key investment considerations:
- Large addressable market: CKD and ASCVD affect millions globally
- Differentiated approach: Targeting residual inflammatory risk could set TOUR006 apart from traditional therapies
- De-risked development: Leveraging data from six previous trials enhances probability of success
- Near-term catalyst: Topline data expected in H1 2025 could be a significant value driver
However, investors should note that success in this indication is not guaranteed and the competitive landscape in cardiovascular therapeutics is intense. The study's outcome will be crucial for Tourmaline's valuation and future pipeline direction.
- Phase 2 TRANQUILITY trial is evaluating the high-sensitivity C-reactive protein (hs-CRP)-lowering effect, safety, tolerability, and pharmacokinetics (PK) of quarterly and monthly subcutaneous administration of TOUR006 in patients with chronic kidney disease and elevated hs-CRP —
- Dosing regimens are informed by six previous Phase 1 and Phase 2 clinical studies in healthy volunteers and patients with inflammatory autoimmune disorders, as well as PK/PD modeling —
- Topline data is expected first half of 2025 —
- Data from Phase 2 TRANQUILITY trial have the potential to advance TOUR006 toward Phase 3 readiness for atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases.
NEW YORK, Aug. 02, 2024 (GLOBE NEWSWIRE) -- Tourmaline Bio, Inc. (Tourmaline) (NASDAQ: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today presented a poster at the American Society of Preventive Cardiology (ASPC) Congress in Salt Lake City, Utah, detailing the rationale and design of the company’s TRANQUILITY Phase 2 study examining the potential of its lead candidate, TOUR006, to reduce high-sensitivity C-reactive protein (hs-CRP), a key biomarker of residual inflammatory cardiovascular risk, in patients with chronic kidney disease (CKD) and elevated hs-CRP.
Patients with CKD and elevated hs-CRP are at heightened risk of atherosclerotic cardiovascular disease (ASCVD), including heart attack, stroke, and peripheral artery disease, despite current standard-of-care treatments. The IL-6 pathway has been identified as a significant contributor to ASCVD risk, particularly in CKD patients. TOUR006 has previously shown promise in reducing hs-CRP levels in patients with inflammatory autoimmune diseases.
“The TRANQUILITY study represents an important step in understanding the potential of TOUR006 to address unmet needs in patients with residual inflammatory cardiovascular risk, despite lifestyle changes and available therapeutic interventions,” said Emil deGoma, MD, Senior Vice President of Medical Research at Tourmaline and former Medical Director of the Preventive Cardiovascular Program at the University of Pennsylvania. “With a robust clinical dataset from six previous trials involving 448 dosed study participants, comprised of healthy volunteers and patients with diseases other than cardiovascular disorders, as well as converging clinical evidence supporting the therapeutic potential of IL-6 inhibition, we are confident in our approach and the potential of TOUR006 and look forward to seeing the data from this study.”
In the poster titled “Evaluating TOUR006 in Participants with Chronic Kidney Disease and Elevated hs-CRP: Rationale and Design of the TRANQUILITY Phase 2 Study,” Tourmaline provided an overview of the study design and rationale behind investigating TOUR006 in patients with CKD and elevated hs-CRP, highlighting:
- Objective: To evaluate the hs-CRP-lowering effect, safety, tolerability, and pharmacokinetics of TOUR006 in patients with CKD and elevated hs-CRP.
- Design: A randomized, double-blind, placebo-controlled, multicenter trial involving approximately 120 patients with CKD stage 3 or 4 and hs-CRP ≥2 and <15 mg/L.
- Methods: Participants are stratified by CKD stage and randomized to receive subcutaneous TOUR006 at doses of 50 mg quarterly, 25 mg quarterly, 15 mg monthly, or placebo. The primary pharmacodynamic endpoint is the change in hs-CRP levels. Additional biomarkers being measured include IL-6, lipoprotein(a), oxidized low-density lipoprotein (LDL), and fibrinogen.
- Timeline: The treatment and follow-up periods are 180 days and 185 days, respectively, with the primary completion expected in May 2025.
The Phase 2 TRANQUILITY trial is expected to inform the dosing regimen and design of any future Phase 3 cardiovascular studies in high-risk patients.
Additional meeting information can be found at https://www.aspconline.org/2024congress
About the Phase 2 TRANQUILITY Trial
The Phase 2 TRANQUILITY trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD), including CRP-lowering effect, of quarterly and monthly subcutaneous administration of TOUR006 in patients with elevated high-sensitivity C-reactive protein (hs-CRP) and chronic kidney disease (CKD). The selection of dosing regimens being evaluated in TRANQUILITY was informed by six previously completed Phase 1 and Phase 2 trials of TOUR006 in healthy volunteers and patients with rheumatoid arthritis, Crohn’s disease, or systemic lupus erythematosus as well as PK/PD modeling. For more information on the TRANQUILITY clinical trial, please visit clinicaltrials.gov (NCT06362759).
About TOUR006
TOUR006 is a long-acting, fully human, anti-IL-6 monoclonal antibody with differentiated properties, including a naturally long half-life, low immunogenicity, and high binding affinity to IL-6. TOUR006 has been previously studied in 448 participants, including patients with autoimmune disorders, across six completed clinical trials. Tourmaline is developing TOUR006 in thyroid eye disease and atherosclerotic cardiovascular disease as its first two indications, with additional diseases under consideration.
About Tourmaline
Tourmaline is a late-stage clinical biotechnology company driven by its mission to develop transformative medicines that dramatically improve the lives of patients with life-altering immune and inflammatory diseases. Tourmaline’s lead asset is TOUR006.
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, but are not limited to, expectations regarding the development and potential therapeutic benefits of TOUR006, including the timing of initiation, progress and results of Tourmaline’s current and future clinical trials for TOUR006, and reporting of data therefrom, including the anticipation that topline data from the Phase 2 TRANQUILITY trial will be available in the first half of 2025, and the expectation that such data, if successful, will position Tourmaline to be Phase 3-ready in 2025 for ASCVD and other cardiovascular diseases; and patient population and market opportunities. 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, including the Phase 2 TRANQUILITY trial; 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 May 13, 2024 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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