Trevi Therapeutics Completes Enrollment for Phase 2b CORAL Trial of Haduvio in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough
Trevi Therapeutics (NASDAQ: TRVI) has completed enrollment in its Phase 2b CORAL trial of Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Topline results are expected in the first half of 2025.
The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in approximately 160 IPF patients with chronic cough over a 6-week period. The study includes a 2-week titration period followed by 4 weeks of fixed dosing.
The primary endpoint measures the relative change in 24-hour cough frequency at Week 6 versus baseline, using an objective cough monitor. Secondary endpoints include patient-reported outcome measures for cough.
According to James Cassella, Chief Development Officer, chronic cough significantly impacts IPF patients, and current treatments are often ineffective, creating a substantial unmet need. Results will help determine optimal doses for the pivotal Phase 3 program.
Trevi Therapeutics (NASDAQ: TRVI) ha completato l'arruolamento nel suo trial di Fase 2b CORAL per Haduvio™ (nalbuphine ER orale) nel trattamento della tosse cronica in pazienti affetti da fibrosi polmonare idiopatica (IPF). I risultati preliminari sono attesi nella prima metà del 2025.
Il trial CORAL sta valutando tre dosi di Haduvio (27mg, 54mg e 108mg due volte al giorno) rispetto al placebo in circa 160 pazienti con IPF e tosse cronica per un periodo di 6 settimane. Lo studio include un periodo di titolazione di 2 settimane seguito da 4 settimane di dosaggio fisso.
Il principale obiettivo misura il cambiamento relativo nella frequenza della tosse in 24 ore alla settimana 6 rispetto al basale, utilizzando un monitor oggettivo della tosse. Gli obiettivi secondari includono misure di esito riportate dai pazienti riguardo alla tosse.
Secondo James Cassella, Chief Development Officer, la tosse cronica ha un impatto significativo sui pazienti con IPF e i trattamenti attuali sono spesso inefficaci, creando un sostanziale bisogno non soddisfatto. I risultati aiuteranno a determinare le dosi ottimali per il programma cruciale di Fase 3.
Trevi Therapeutics (NASDAQ: TRVI) ha completado la inscripción en su ensayo de Fase 2b CORAL para Haduvio™ (nalbufina ER oral) para tratar la tos crónica en pacientes con fibrosis pulmonar idiopática (FPI). Se esperan resultados preliminares en la primera mitad de 2025.
El ensayo CORAL está evaluando tres dosis de Haduvio (27mg, 54mg y 108mg dos veces al día) frente a placebo en aproximadamente 160 pacientes con FPI y tos crónica durante un periodo de 6 semanas. El estudio incluye un periodo de titulación de 2 semanas seguido de 4 semanas de dosificación fija.
El objetivo primario mide el cambio relativo en la frecuencia de tos de 24 horas en la semana 6 en comparación con la línea base, utilizando un monitor objetivo de tos. Los objetivos secundarios incluyen medidas de resultado reportadas por los pacientes para la tos.
Según James Cassella, Director de Desarrollo, la tos crónica impacta significativamente a los pacientes con FPI y los tratamientos actuales son a menudo ineficaces, creando una necesidad insatisfecha considerable. Los resultados ayudarán a determinar las dosis óptimas para el programa crucial de Fase 3.
Trevi Therapeutics (NASDAQ: TRVI)는 Haduvio™ (경구용 날부핀 ER)의 만성 기침 치료를 위한 2b상 CORAL 시험의 등록을 완료했습니다. 특발성 폐섬유증 (IPF) 환자에서의 만성 기침 치료를 위한 것입니다. 주요 결과는 2025년 상반기에 발표될 예정입니다.
CORAL 시험은 약 160명의 만성 기침 환자를 대상으로 Haduvio의 세 가지 용량(27mg, 54mg 및 108mg)을 위약과 비교하여 6주 동안 평가하고 있습니다. 이 연구는 2주간의 용량 조정 기간과 4주간의 고정 용량 투여 기간을 포함합니다.
주요 목표는 6주차에 24시간 기침 빈도의 상대적 변화를 기준선과 비교하여 측정하며, 객관적인 기침 모니터를 사용합니다. 2차 목표는 기침에 대한 환자 보고 결과 측정입니다.
James Cassella, 최고 개발 책임자에 따르면, 만성 기침은 IPF 환자에게 상당한 영향을 미치며, 현재의 치료법은 종종 효과가 없어서 상당한 충족되지 않은 필요를 초래합니다. 결과는 3상 주요 프로그램을 위한 최적의 용량을 결정하는 데 도움이 될 것입니다.
Trevi Therapeutics (NASDAQ: TRVI) a terminé l'inscription de ses participants à l'essai CORAL de Phase 2b pour Haduvio™ (nalbuphine ER orale) visant à traiter la toux chronique chez des patients atteints de fibrose pulmonaire idiopathique (FPI). Les résultats préliminaires sont attendus dans la première moitié de 2025.
L'essai CORAL évalue trois doses de Haduvio (27mg, 54mg et 108mg deux fois par jour) par rapport à un placebo chez environ 160 patients atteints de FPI avec toux chronique sur une période de 6 semaines. L'étude comprend une période de titration de 2 semaines suivie de 4 semaines de dosage fixe.
L'objectif principal mesure le changement relatif de la fréquence de toux sur 24 heures à la semaine 6 par rapport à la ligne de base, en utilisant un moniteur de toux objectif. Les objectifs secondaires incluent des mesures des résultats rapportées par les patients concernant la toux.
Selon James Cassella, directeur du développement, la toux chronique a un impact significatif sur les patients atteints de FPI, et les traitements actuels sont souvent inefficaces, créant un besoin non satisfait considérable. Les résultats aideront à déterminer les doses optimales pour le programme clé de Phase 3.
Trevi Therapeutics (NASDAQ: TRVI) hat die Rekrutierung für seine Phase 2b CORAL-Studie zu Haduvio™ (orale Nalbufin ER) zur Behandlung von chronischem Husten bei Patienten mit idiopathischer Lungenfibrose (IPF) abgeschlossen. Die ersten Ergebnisse werden in der ersten Hälfte des Jahres 2025 erwartet.
Die CORAL-Studie bewertet drei Dosen von Haduvio (27mg, 54mg und 108mg zweimal täglich) im Vergleich zu Placebo bei etwa 160 IPF-Patienten mit chronischem Husten über einen Zeitraum von 6 Wochen. Die Studie umfasst eine 2-wöchige Titrationsphase, gefolgt von 4 Wochen mit fester Dosierung.
Das primäre Ziel misst die relative Veränderung der Hustenfrequenz über 24 Stunden in Woche 6 im Vergleich zur Ausgangsbasis unter Verwendung eines objektiven Hustenschreibers. Sekundäre Endpunkte umfassen von Patienten berichtete Ergebnisse zum Husten.
Laut James Cassella, Chief Development Officer, hat chronischer Husten erhebliche Auswirkungen auf IPF-Patienten, und die derzeitigen Behandlungen sind oft ineffektiv, was einen erheblichen ungedeckten Bedarf schafft. Die Ergebnisse werden helfen, die optimalen Dosen für das entscheidende Phase-3-Programm zu bestimmen.
- Completed enrollment in Phase 2b CORAL trial for Haduvio
- Topline results expected in first half of 2025
- Addressing significant unmet need for IPF patients with chronic cough
- Successful completion positions company for potential Phase 3 program
- Results not yet available to confirm efficacy
- Still in Phase 2b, requiring successful Phase 3 trials before potential approval
- Competition from other treatments in development for IPF-related cough
Insights
Trevi Therapeutics has reached a significant clinical milestone with the completion of enrollment in its Phase 2b CORAL trial for Haduvio in idiopathic pulmonary fibrosis (IPF) patients with chronic cough. This development maintains the company's timeline for topline data delivery in H1 2025, positioning Trevi at a important juncture in its clinical development strategy.
The trial's design is robust, evaluating three dose levels (27mg, 54mg, and 108mg twice daily) against placebo in approximately 160 IPF patients over a 6-week period. The primary endpoint focuses on objectively measured changes in 24-hour cough frequency, supplemented by patient-reported outcomes as secondary endpoints.
Haduvio (nalbuphine ER) works as a dual-acting opioid receptor modulator, functioning as both a mu opioid receptor antagonist and a kappa opioid receptor agonist. This unique mechanism provides a scientific rationale for addressing the neurological pathways involved in chronic cough without the respiratory depression risks associated with traditional opioids.
The IPF chronic cough market represents a significant opportunity with approximately 140,000 IPF patients in the US, of whom roughly 85% suffer from chronic cough. With no FDA-approved treatments specifically for IPF-related cough, Haduvio could potentially command premium pricing in this high-unmet-need indication.
From a financial perspective, this milestone reduces operational risk in Trevi's lead program. The company reported $94.8 million in cash and investments as of their last quarterly report, providing runway into 2026 – comfortably beyond this important data readout. Positive results could significantly impact Trevi's $395 million market capitalization, potentially triggering partnership discussions or enabling favorable financing terms for Phase 3 development.
The competitive landscape remains relatively sparse, with few advanced-stage competitors specifically targeting IPF-related cough. This provides Trevi with a potential first-mover advantage if Haduvio demonstrates efficacy. Previous encouraging data from Trevi's Phase 2 trial in refractory chronic cough provides some validation for Haduvio's mechanism in cough suppression, though success in the IPF population isn't guaranteed.
While enrollment completion is positive, investors should recognize that the critical value inflection point remains the topline data readout. The 6-week treatment duration suggests data cleaning and analysis will occupy much of the remaining time until the H1 2025 readout, with few interim catalysts expected.
Topline results continue to be expected in the first half of 2025
"The completion of enrollment in the Phase 2b CORAL trial is a significant milestone in the development of Haduvio for patients with idiopathic pulmonary fibrosis suffering from chronic cough," said James Cassella, Chief Development Officer of Trevi Therapeutics. "Chronic cough has a significant impact on IPF patients, and its persistent physical effects may worsen a patient's overall health. Current off-label treatments and antifibrotics are often ineffective against chronic cough, leaving a substantial unmet need. The results from this study will help us determine the optimal doses of Haduvio to move into our pivotal Phase 3 program. We look forward to reporting topline data in the first half of this year."
Phase 2b IPF Chronic Cough Trial Design (CORAL):
The CORAL trial is a double-blind, randomized, placebo-controlled, parallel-arm trial evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) compared to placebo in IPF patients with chronic cough over a 6-week period. Approximately 160 IPF patients with chronic cough were randomized 1:1:1:1 to one of three Haduvio doses or placebo with an initial 2-week titration period to the target dose followed by 4 weeks of fixed dosing. The primary efficacy endpoint for the trial is the relative change in 24-hour cough frequency at the end of Week 6 versus baseline for Haduvio compared to placebo, as measured with an objective cough monitor. The trial will also explore secondary endpoints, including patient reported outcome measures for cough.
About Idiopathic Pulmonary Fibrosis Chronic Cough
Chronic cough is highly prevalent in IPF patients, impacting up to
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), which are opioid receptors that play a key role in controlling cough hypersensitivity. Nalbuphine is not currently scheduled by the
Refractory chronic cough affects approximately 2-3 million adults in the
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's expectation of reporting topline data from Trevi's Phase 2b CORAL trial in the first half of 2025. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties regarding the success and timing of Trevi's product candidate development activities, including its ongoing clinical trials, uncertainties regarding Trevi's ability to execute on its strategy, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission and in subsequent filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
carlsonj@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
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