Trevi Therapeutics Announces Additional Analyses of Cough Relief Time from Ph2a CANAL Trial Accepted for Oral Presentation at CHEST 2024
Trevi Therapeutics (Nasdaq: TRVI) announced that additional analyses of cough relief time from their Phase 2a CANAL trial have been accepted for oral presentation at CHEST 2024. The presentation, by Professor Alyn Morice, will cover post-hoc analyses of 38 IPF patients who completed at least one treatment period. Results showed:
1. Significant increase in relief-of-cough time
2. Reduced cough time
3. Reduced cough intensity
These effects were observed in IPF patients treated with nalbuphine ER compared to placebo. The safety profile was consistent with previous trials. Common adverse events included nausea, dizziness, and anxiety. The presentation is scheduled for October 8, 2024, at the CHEST Annual Meeting in Boston.
Trevi Therapeutics (Nasdaq: TRVI) ha annunciato che ulteriori analisi del tempo di sollievo dalla tosse del loro studio di Fase 2a CANAL sono state accettate per una presentazione orale al CHEST 2024. La presentazione, a cura del Professor Alyn Morice, riguarderà le analisi post-hoc di 38 pazienti con FPI che hanno completato almeno un periodo di trattamento. I risultati hanno mostrato:
1. Aumento significativo del tempo di sollievo dalla tosse
2. Riduzione del tempo di tosse
3. Riduzione dell'intensità della tosse
Questi effetti sono stati osservati nei pazienti con FPI trattati con nalbuphina ER rispetto al placebo. Il profilo di sicurezza è stato in linea con studi precedenti. Gli eventi avversi comuni includevano nausea, vertigini e ansia. La presentazione è programmata per l'8 ottobre 2024, durante il Congresso Annuale CHEST a Boston.
Trevi Therapeutics (Nasdaq: TRVI) anunció que análisis adicionales del tiempo de alivio de la tos de su ensayo de Fase 2a CANAL han sido aceptados para presentación oral en CHEST 2024. La presentación, a cargo del Profesor Alyn Morice, cubrirá análisis post-hoc de 38 pacientes con FPI que completaron al menos un período de tratamiento. Los resultados mostraron:
1. Aumento significativo en el tiempo de alivio de la tos
2. Reducción del tiempo de tos
3. Reducción de la intensidad de la tos
Estos efectos fueron observados en pacientes con FPI tratados con nalbuphina ER en comparación con placebo. El perfil de seguridad fue consistente con ensayos previos. Los eventos adversos comunes incluyeron náuseas, mareos y ansiedad. La presentación está programada para el 8 de octubre de 2024, en la Reunión Anual CHEST en Boston.
Trevi Therapeutics (Nasdaq: TRVI)는 기침 완화 시간에 대한 추가 분석이 2a 단계 CANAL 시험에서 CHEST 2024에서 구두 발표로 수락되었다고 발표했습니다. 발표는 Alyn Morice 교수에 의해 진행되며, 38명의 IPF 환자를 대상으로 한 후속 분석을 다룰 것입니다. 결과는 다음과 같습니다:
1. 기침 완화 시간의 유의미한 증가
2. 기침 시간의 감소
3. 기침 강도의 감소
이러한 효과는 플라시보와 비교하여 nalbuphine ER로 치료받은 IPF 환자에서 관찰되었습니다. 안전성 프로필은 이전 시험과 일치했습니다. 일반적인 부작용으로는 메스꺼움, 현기증, 불안이 포함되었습니다. 발표는 2024년 10월 8일 보스턴에서 열리는 CHEST 연례 회의에서 예정되어 있습니다.
Trevi Therapeutics (Nasdaq: TRVI) a annoncé que des analyses supplémentaires sur le temps de soulagement de la toux de leur essai de Phase 2a CANAL ont été acceptées pour une présentation orale au CHEST 2024. La présentation, par le Professeur Alyn Morice, portera sur des analyses post-hoc de 38 patients atteints de FPI ayant terminé au moins une période de traitement. Les résultats ont montré :
1. Augmentation significative du temps de soulagement de la toux
2. Réduction du temps de toux
3. Diminution de l'intensité de la toux
Ces effets ont été observés chez des patients atteints de FPI traités avec nalbuphine ER par rapport au placebo. Le profil de sécurité était cohérent avec les essais précédents. Les effets indésirables courants comprenaient des nausées, des vertiges et de l'anxiété. La présentation est prévue pour le 8 octobre 2024, lors de la Réunion Annuelle CHEST à Boston.
Trevi Therapeutics (Nasdaq: TRVI) gab bekannt, dass zusätzliche Analysen der Hustenlinderungszeit aus ihrer Phase-2a CANAL-Studie zur mündlichen Präsentation bei CHEST 2024 akzeptiert wurden. Die Präsentation, gehalten von Professor Alyn Morice, wird Post-Hoc-Analysen von 38 IPF-Patienten behandeln, die mindestens einen Behandlungszeitraum abgeschlossen haben. Die Ergebnisse zeigten:
1. Signifikanter Anstieg der Hustenlinderungszeit
2. Verkürzte Hustenzeit
3. Verminderte Hustenintensität
Diese Effekte wurden bei IPF-Patienten beobachtet, die mit nalbuphine ER im Vergleich zu Placebo behandelt wurden. Das Sicherheitsprofil entsprach dem vorheriger Studien. Häufige Nebenwirkungen waren Übelkeit, Schwindel und Angst. Die Präsentation ist für den 8. Oktober 2024 auf dem CHEST-Jahrestreffen in Boston geplant.
- Acceptance of additional analyses for oral presentation at CHEST 2024, a significant medical conference
- Positive results showing significant increase in relief-of-cough time and reduced cough time and intensity in IPF patients
- Safety profile consistent with previous trials, indicating no new safety concerns
- Reported adverse events including nausea, dizziness, anxiety, and other side effects
- Results based on post-hoc analyses, which may be considered less robust than pre-planned analyses
Insights
The acceptance of additional analyses from Trevi Therapeutics' Phase 2a CANAL trial for oral presentation at CHEST 2024 is a positive development for the company's chronic cough treatment program. The data, focusing on cough relief in idiopathic pulmonary fibrosis (IPF) patients treated with nalbuphine ER, demonstrates:
- Significant increase in relief-of-cough time
- Reduced cough time
- Reduced cough intensity
These results suggest potential efficacy of Haduvio™ (oral nalbuphine ER) in treating chronic cough in IPF patients. The safety profile appears consistent with previous trials, which is reassuring for ongoing development.
For investors, this presentation represents an important validation of Trevi's approach and could generate increased interest in the company's pipeline. However, it's important to note that this is still early-stage data and further clinical trials will be necessary to confirm these findings and support potential regulatory approval.
The presentation at a prestigious conference like CHEST 2024 also provides valuable exposure for Trevi within the medical community, potentially facilitating future partnerships or collaborations.
Professor Alyn Morice will present an analysis of cough relief in patients with idiopathic pulmonary fibrosis who were treated with nalbuphine ER
The presentation by Professor Alyn Morice, Head of Respiratory Medicine at HYMS and leader of the Hull Cough Clinic, will take place on October 8th and include cough data from 38 IPF patients who completed at least 1 treatment period of the CANAL trial. The presentation covers post-hoc analyses of patients' relief-of-cough duration (any ≥15-minute cough-free period), cough time (total observation time – relief time), and cough intensity (number of coughs during coughing time). The results demonstrated a significant increase in relief-of-cough time, reduced cough time, and reduced cough intensity in IPF patients with nalbuphine ER compared with placebo. The safety results of the trial were generally consistent with the known safety profile of nalbuphine ER from previous trials. The most frequently reported treatment-emergent adverse events with nalbuphine ER treatment were nausea, dizziness, anxiety, constipation, vomiting, dry mouth, headache, somnolence, dyspnea, decreased appetite, fatigue and lethargy.
CHEST 2024
October 6 – 9, 2024,
Session: ILD Abstracts Potpourri
Presentation Date & Time: October 8, 1:51 p.m. – 1:55 p.m. EDT
Location: Convention Center Exhibit Hall, Area 2B
Abstract Accepted for Oral Presentation: Analysis of Relief-Of-Cough in Patients with Idiopathic Pulmonary Fibrosis Treated with Oral Nalbuphine Extended Release
Presenter: Professor Alyn Morice is Head of Respiratory Medicine at HYMS and leader of the Hull Cough Clinic. Registration details: CHEST Annual Meeting
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Haduvio is an extended-release (ER) dual ĸ-opioid receptor agonist and µ-opioid receptor antagonist that works both centrally in the brain as well as peripherally in the lungs and has the potential for a synergistic antitussive effect to treat chronic cough. Parenteral nalbuphine is not scheduled by the
The impact of chronic cough is significant and often leads to a decline in patients' social, physical, and psychological quality of life. In IPF, chronic cough may lead to worsening disease and may be associated with a higher risk of progression, death, or need for lung transplant. There are no approved therapies for the treatment of chronic cough in IPF and current treatment options provide minimal benefit to patients. Chronic cough affects up to
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.
Investor Contact
Katie McManus
Trevi Therapeutics, Inc.
203-304-2499
k.mcmanus@trevitherapeutics.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/trevi-therapeutics-announces-additional-analyses-of-cough-relief-time-from-ph2a-canal-trial-accepted-for-oral-presentation-at-chest-2024-302259142.html
SOURCE Trevi Therapeutics, Inc.
FAQ
What are the key findings from Trevi Therapeutics' (TRVI) CANAL trial presented at CHEST 2024?
When and where will Trevi Therapeutics (TRVI) present their CANAL trial results?
What were the common side effects reported in Trevi Therapeutics' (TRVI) nalbuphine ER trial?
How many patients were included in the analysis of Trevi Therapeutics' (TRVI) CANAL trial?
