8-K: Trevi Therapeutics' CORAL Trial Sample Size Re-estimation Confirms No Change Needed, Topline Results Expected in First Half of 2025

Trevi Therapeutics announced that the sample size re-estimation for its Phase 2b CORAL trial in idiopathic pulmonary fibrosis patients with chronic cough requires no change to the current sample size, with topline results expected in the first half of 2025.

Summary

• Trevi Therapeutics has completed a planned sample size re-estimation (SSRE) for its ongoing Phase 2b CORAL trial, which is studying a treatment for chronic cough in patients with idiopathic pulmonary fibrosis.
• The SSRE analysis was conducted after 50% of the initial targeted trial enrollment, or 80 patients, completed six weeks of treatment using the highest dose of 108mg twice daily.
• The analysis concluded that no change to the current sample size of 160 patients is needed to maintain the pre-specified conditional power of 80% or greater.
• The trial has reached 75% of the targeted enrollment.
• Topline results from the full trial are still expected in the first half of 2025.

Sentiment

Score: 7

Explanation: The document conveys a positive update on the clinical trial progress, with no negative surprises. The trial is proceeding as planned, and the timeline for results remains on track. However, there are inherent risks in clinical trials, which temper the overall sentiment.

Positives

• The SSRE analysis confirmed that the trial can proceed as planned without needing to increase the sample size, saving time and resources.
• The trial is progressing well, having reached 75% of its targeted enrollment.
• The timeline for topline results remains on track for the first half of 2025.

Risks

• The success of the trial is not guaranteed, and positive data from the SSRE analysis may not predict the results of later clinical trials.
• There are uncertainties regarding the company's ability to execute its strategy.
• Regulatory authorities may have different views on the data from the clinical trials.
• The company's business plans and objectives are subject to risks and uncertainties.

Future Outlook

Topline results from the full CORAL trial are expected in the first half of 2025.

Management Comments

• The company announced the positive outcome from the planned sample size re-estimation for the ongoing Phase 2b CORAL trial.

Industry Context

This announcement is relevant to the pharmaceutical industry, specifically companies developing treatments for respiratory diseases like idiopathic pulmonary fibrosis and chronic cough. The successful completion of the SSRE is a positive step in the clinical development process.

Comparison to Industry Standards

• The Phase 2b trial design and the use of sample size re-estimation are common practices in the pharmaceutical industry to optimize trial efficiency and reduce risk.
• Other companies developing treatments for idiopathic pulmonary fibrosis and chronic cough include Boehringer Ingelheim, Roche, and Galapagos, which are also conducting clinical trials with similar endpoints.
• The 80% conditional power target is a standard benchmark for clinical trial design, indicating a reasonable probability of detecting a treatment effect if one exists.

Stakeholder Impact

• Shareholders will view this as a positive update on the company's clinical development program.
• Patients with idiopathic pulmonary fibrosis and chronic cough may benefit from the potential treatment being developed.
• Employees of Trevi Therapeutics will continue to work on the clinical trial and related activities.

Next Steps

• The company will continue to enroll patients in the CORAL trial to reach the target of 160 patients.
• The company will analyze the data from the full trial and report topline results in the first half of 2025.

Key Dates

Keywords

Trevi Therapeutics, CORAL trial, idiopathic pulmonary fibrosis, chronic cough, sample size re-estimation, clinical trial, Haduvio, Phase 2b