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Trevi Therapeutics Q1 2025: Unraveling Contradictions in Clinical Trial Timelines and Study Impacts
Generated by AI AgentEarnings Decrypt
Monday, May 19, 2025 9:19 am ET1min read
Powered discontinuation rate for the CORAL trial, timeline for respiratory physiology study, respiratory physiology study timeline, and HAP study status and impact are the key contradictions discussed in Therapeutics' latest 2025Q1 earnings call.
Positive Clinical Trial Results:
- reported significant results from the Phase 2a RIVER trial in refractory chronic cough (RCC) patients, with Haduvio meeting the primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a P value of less than 0.0001.
- The positive outcomes are due to Haduvio's central and peripheral mechanism, which addresses cough hypersensitivity at the brain level and shows a broader effect across different cough counts compared to other peripheral-only therapies.
Completing Enrollment for Phase 2b CORAL Trial:
- Trevi Therapeutics completed enrollment in the Phase 2b CORAL trial for the treatment of chronic cough in IPF patients, with approximately 160 patients enrolled in 10 countries and across 60 sites.
- The completion of enrollment is part of the company's strategy to advance its development program for both chronic cough conditions of IPF and RCC.
FDA Guidance and Collaboration:
- Trevi received clear guidance from the FDA through a Type C request, with the FDA meeting their goal date and providing responses on a technical matter in the development program.
- The timely and effective communication from the FDA is crucial for Trevi to continue its development programs, and the new leadership is expected to prioritize this aspect of the FDA's role.
Strategic Partnership and Commercialization:
- Trevi Therapeutics is engaged in strategic conversations with potential partners for commercialization in Europe and Japan, while preparing to handle US operations independently.
- This strategy is based on the company's data-driven approach and its readiness to handle commercialization without a straight acquisition.
Positive Clinical Trial Results:
- reported significant results from the Phase 2a RIVER trial in refractory chronic cough (RCC) patients, with Haduvio meeting the primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a P value of less than 0.0001.
- The positive outcomes are due to Haduvio's central and peripheral mechanism, which addresses cough hypersensitivity at the brain level and shows a broader effect across different cough counts compared to other peripheral-only therapies.
Completing Enrollment for Phase 2b CORAL Trial:
- Trevi Therapeutics completed enrollment in the Phase 2b CORAL trial for the treatment of chronic cough in IPF patients, with approximately 160 patients enrolled in 10 countries and across 60 sites.
- The completion of enrollment is part of the company's strategy to advance its development program for both chronic cough conditions of IPF and RCC.
FDA Guidance and Collaboration:
- Trevi received clear guidance from the FDA through a Type C request, with the FDA meeting their goal date and providing responses on a technical matter in the development program.
- The timely and effective communication from the FDA is crucial for Trevi to continue its development programs, and the new leadership is expected to prioritize this aspect of the FDA's role.
Strategic Partnership and Commercialization:
- Trevi Therapeutics is engaged in strategic conversations with potential partners for commercialization in Europe and Japan, while preparing to handle US operations independently.
- This strategy is based on the company's data-driven approach and its readiness to handle commercialization without a straight acquisition.
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