Tourmaline Bio Highlights Cardiovascular Inflammation Focus and Announces Key Clinical and Strategic Updates at Investor Day
Tourmaline Bio (NASDAQ: TRML) announced key updates at its Investor Day, highlighting progress in its cardiovascular inflammation programs. The company's Phase 2 TRANQUILITY trial has exceeded its enrollment target with 143 patients, surpassing the original 120-patient goal. Topline data is expected in Q2 2025.
The company expanded its Cardiovascular Scientific Advisory Board with two new appointments: Dr. Deepak L. Bhatt as Chair and Dr. Dipender Gill. Additionally, Tourmaline nominated abdominal aortic aneurysm (AAA) as a second cardiovascular indication for its drug pacibekitug, with plans for a Phase 2 proof-of-concept trial after TRANQUILITY results.
Regarding its Thyroid Eye Disease program, the initiation of Phase 3 trials will depend on results from the ongoing Phase 2b spiriTED trial, with topline data expected in H2 2025.
Tourmaline Bio (NASDAQ: TRML) ha annunciato aggiornamenti chiave nel suo Investor Day, evidenziando i progressi nei suoi programmi per l'infiammazione cardiovascolare. La fase 2 del trial TRANQUILITY ha superato l'obiettivo di arruolamento con 143 pazienti, superando il target originale di 120 pazienti. I dati preliminari sono attesi nel secondo trimestre del 2025.
L'azienda ha ampliato il suo comitato scientifico consultivo cardiovascolare con due nuove nomine: il Dr. Deepak L. Bhatt come presidente e il Dr. Dipender Gill. Inoltre, Tourmaline ha nominato l'aneurisma aortico addominale (AAA) come seconda indicazione cardiovascolare per il suo farmaco pacibekitug, con piani per un trial di prova di concetto di fase 2 dopo i risultati di TRANQUILITY.
Per quanto riguarda il suo programma sulla malattia tiroidea oculare, l'inizio dei trial di fase 3 dipenderà dai risultati dell'attuale trial di fase 2b spiriTED, con dati preliminari attesi nella seconda metà del 2025.
Tourmaline Bio (NASDAQ: TRML) anunció actualizaciones clave en su Día del Inversor, destacando los avances en sus programas de inflamación cardiovascular. El ensayo de fase 2 TRANQUILITY ha superado su objetivo de inscripción con 143 pacientes, superando la meta original de 120 pacientes. Se esperan datos preliminares en el segundo trimestre de 2025.
La compañía amplió su Consejo Asesor Científico de Cardiología con dos nuevos nombramientos: el Dr. Deepak L. Bhatt como presidente y el Dr. Dipender Gill. Además, Tourmaline nominó el aneurisma aórtico abdominal (AAA) como una segunda indicación cardiovascular para su medicamento pacibekitug, con planes de un ensayo de prueba de concepto de fase 2 después de los resultados de TRANQUILITY.
En cuanto a su programa de Enfermedad del Ojo Tiroideo, el inicio de los ensayos de fase 3 dependerá de los resultados del ensayo en fase 2b spiriTED en curso, con datos preliminares esperados en la segunda mitad de 2025.
투말린 바이오 (NASDAQ: TRML)는 투자자 발표회에서 심혈관염증 프로그램의 진전을 강조하며 주요 업데이트를 발표했습니다. TRANQUILITY 시험의 2상에서 143명의 환자를 모집하여 원래 목표인 120명을 초과했습니다. 주요 데이터는 2025년 2분기에 예상됩니다.
회사는 두 명의 새로운 위원 임명으로 심혈관 과학 자문 위원회를 확장했습니다: Dr. Deepak L. Bhatt가 의장으로, Dr. Dipender Gill이 새로 합류했습니다. 또한 투말린은 약물 pacibekitug의 두 번째 심혈관 적응증으로 복부 대동맥류 (AAA)를 지명했으며, TRANQUILITY 결과 이후 2상 개념 증명 시험을 계획하고 있습니다.
갑상선 안 질환 프로그램과 관련하여 3상 시험 시작은 진행 중인 2b상 spiriTED 시험의 결과에 따라 다를 것이며, 주요 데이터는 2025년 하반기에 예상됩니다.
Tourmaline Bio (NASDAQ: TRML) a annoncé des mises à jour clés lors de son Investor Day, mettant en avant des progrès dans ses programmes d'inflammation cardiovasculaire. L'essai de phase 2 TRANQUILITY a dépassé son objectif d'inscription avec 143 patients, surpassant l'objectif initial de 120 patients. Les données préliminaires sont attendues au deuxième trimestre de 2025.
L'entreprise a élargi son Conseil Scientifique Consultatif Cardiovasculaire avec deux nouvelles nominations : Dr. Deepak L. Bhatt en tant que président et Dr. Dipender Gill. De plus, Tourmaline a nommé l'aneurysme aortique abdominal (AAA) comme deuxième indication cardiovasculaire pour son médicament pacibekitug, avec des projets pour un essai de preuve de concept de phase 2 après les résultats de TRANQUILITY.
Concernant son programme sur la maladie oculaire thyroïdienne, le début des essais de phase 3 dépendra des résultats de l'essai de phase 2b en cours, spiriTED, avec des données préliminaires attendues au second semestre 2025.
Tourmaline Bio (NASDAQ: TRML) gab auf seinem Investor Day wichtige Aktualisierungen bekannt und hob den Fortschritt seiner Programme zur kardiovaskulären Entzündung hervor. Die Phase-2-Studie TRANQUILITY hat das Rekrutierungsziel mit 143 Patienten überschritten und damit das ursprüngliche Ziel von 120 Patienten übertroffen. Die wichtigsten Daten werden im 2. Quartal 2025 erwartet.
Das Unternehmen hat seinen Wissenschaftlichen Beirat für Kardiologie mit zwei neuen Ernennungen erweitert: Dr. Deepak L. Bhatt als Vorsitzenden und Dr. Dipender Gill. Darüber hinaus nominierte Tourmaline das abdominale Aortenaneurysma (AAA) als zweite kardiovaskuläre Indikation für sein Medikament pacibekitug, mit Plänen für eine Phase-2-Studie nach den TRANQUILITY-Ergebnissen.
In Bezug auf sein Programm zur Augenerkrankung der Schilddrüse wird der Beginn von Phase-3-Studien von den Ergebnissen der laufenden Phase-2b-Studie spiriTED abhängen, wobei die Ergebnisse für die zweite Jahreshälfte 2025 erwartet werden.
- TRANQUILITY trial exceeded enrollment target by 19% (143 vs 120 planned patients)
- Addition of abdominal aortic aneurysm as new indication expands market potential
- Appointment of prominent cardiovascular experts to Scientific Advisory Board strengthens development strategy
- Phase 3 TED program progression contingent on Phase 2b results, indicating uncertainty in pipeline advancement
Insights
The Phase 2 TRANQUILITY trial's over-enrollment to 143 patients (versus 120 planned) strengthens the study's statistical power and demonstrates strong investigator interest. The trial's focus on patients with elevated high-sensitivity C-reactive protein and chronic kidney disease targets a critical intersection of cardiovascular and inflammatory disease.
The expansion into abdominal aortic aneurysm (AAA) represents a strategic opportunity, as AAA currently lacks effective pharmacological treatments. The company's decision to prioritize cardiovascular inflammation over thyroid eye disease (TED) appears scientifically sound, given the larger market opportunity and unmet medical need in cardiovascular disease.
The addition of Dr. Bhatt and Dr. Gill to the Scientific Advisory Board brings valuable expertise in cardiovascular clinical trials and genetic evidence-based drug development, critical for the company's strategic direction in inflammation-driven cardiovascular diseases.
This strategic update reveals a focused approach to maximizing pacibekitug's commercial potential in the lucrative cardiovascular market. The over-enrollment in the TRANQUILITY trial and expansion into AAA indication demonstrate efficient capital allocation and pipeline expansion without additional compound development costs.
The company's pivot to prioritize cardiovascular inflammation over TED shows disciplined resource management and targeting of larger market opportunities. With clear timelines for data readouts in Q2 2025 for TRANQUILITY and H2 2025 for spiriTED, investors have multiple potential value-creating catalysts to monitor.
The high-profile additions to the Scientific Advisory Board enhance the company's credibility in the cardiovascular space and could facilitate future partnerships or clinical trial execution.
– Phase 2 TRANQUILITY trial surpasses enrollment target, with 143 total patients enrolled; topline data expected in second quarter of 2025 –
– Deepak L. Bhatt, MD, MPH, MBA and Dipender Gill, MD, PhD join Cardiovascular Scientific Advisory Board –
– Company nominates abdominal aortic aneurysm as second cardiovascular indication for pacibekitug, expanding development for inflammation-driven cardiovascular disease –
NEW YORK, Dec. 10, 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 is hosting its Investor Day, beginning at 10 a.m. ET, during which it will outline progress across its pipeline and provide updates on its strategic priorities.
“We continue to be laser-focused on our development efforts for pacibekitug in order to maximize the potential of this program,” said Sandeep Kulkarni, MD, Co-Founder and Chief Executive Officer of Tourmaline Bio. “Today’s updates, including the over-enrollment of our TRANQUILITY trial, the expansion of our Cardiovascular Scientific Advisory Board, and the addition of a new indication, reflect the strength of our science, the caliber of our team, and our commitment to redefining standards of care for patients worldwide.”
Phase 2 TRANQUILITY Trial Progress
Tourmaline today is announcing the over-enrollment of its Phase 2 TRANQUILITY trial, which evaluates quarterly and monthly subcutaneous dosing of pacibekitug in patients with elevated high-sensitivity C-reactive protein and chronic kidney disease. A total of 143 patients have been enrolled in the Phase 2 TRANQUILITY trial, as compared to 120 patients originally anticipated. Tourmaline expects to report topline data from this trial in the second quarter of 2025.
The TRANQUILITY trial is the starting point of Tourmaline’s clinical development program for pacibekitug for the potential treatment of atherosclerotic cardiovascular disease (ASCVD) and other cardiovascular diseases. If successful, results from the TRANQUILITY trial are expected to position Tourmaline to be Phase 3-ready for ASCVD.
Expansion of Cardiovascular Scientific Advisory Board (CV SAB)
Tourmaline has expanded its CV SAB with two new appointments:
- Deepak L. Bhatt, MD, MPH, MBA, FACC, FAHA, FESC, MSCAI joins as Chair of the Tourmaline CV SAB. Dr. Bhatt is the Director of the Mount Sinai Fuster Heart Hospital and the Dr. Valentin Fuster Professor of Cardiovascular Medicine at the Icahn School of Medicine at Mount Sinai in New York City. Dr. Bhatt has served as principal investigator for a number of groundbreaking cardiovascular clinical trials, bringing to the CV SAB decades of clinical trial expertise.
- Dipender Gill, MD, PhD is the CEO of Sequoia Genetics and a specialist in leveraging human genetic evidence for drug development. Dr. Gill adds deep translational insight to Tourmaline’s strategic focus.
Indication Expansion in Cardiovascular Inflammation
Tourmaline has nominated abdominal aortic aneurysm (AAA) as an additional indication within its cardiovascular inflammation disease focus for pacibekitug. Tourmaline expects to provide additional details on a planned Phase 2 proof-of-concept trial in AAA after topline results from the Phase 2 TRANQUILITY trial are reported in Q2 2025.
Update on Thyroid Eye Disease (TED) Development Program
In light of Tourmaline’s focus on cardiovascular inflammation, initiation of a Phase 3 trial in TED will be dependent upon results from the ongoing Phase 2b spiriTED trial. Topline data from the Phase 2b spiriTED trial are expected in the second half of 2025; Tourmaline expects to provide additional information on its future development plans in TED at that time.
Investor Day Event Information
Tourmaline’s Investor Day will take place on December 10, 2024, beginning at 10 a.m. ET. To register for Tourmaline’s Investor Day, please click here or visit the Events and Presentations section of Tourmaline’s website. A replay of the webcast will be available on Tourmaline’s website following the event. It is recommended that participants register at least 15 minutes in advance of the event.
About Tourmaline Bio
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 pacibekitug (also referred to as TOUR006). For more information about Tourmaline Bio and pacibekitug, please visit https://www.tourmalinebio.com or follow us on LinkedIn or X.
About Pacibekitug
Pacibekitug (also referred to as TOUR006) 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.
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 and additional details regarding the planning thereof; the timing of future announcements regarding Tourmaline’s development plans and the content of such announcements; the timing of a planned Phase 2 proof-of-concept clinical trial and of Phase 3 clinical trial readiness; and the timing and 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 and clinical 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 and/or current or future target indications; 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 November 7, 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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FAQ
When will Tourmaline Bio (TRML) release TRANQUILITY trial topline data?
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