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Trevi Therapeutics Announces Positive Outcome from Sample Size Re-estimation Resulting in No Change to the Current Sample Size for the Phase 2b CORAL Trial in Idiopathic Pulmonary Fibrosis Patients with Chronic Cough
Thursday, 12th December at 7:30 am
Independent Data Monitoring Statistician reaffirmed current sample size to remain at N=160
The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025
NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160). The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025.
Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">
The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment. Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater. The other two potential pre-specified outcomes of the SSRE analysis were an increase in the sample size or futility.
Thursday, 12th December at 7:30 am
Independent Data Monitoring Statistician reaffirmed current sample size to remain at N=160
The trial has reached 75% of the targeted enrollment, and topline results continue to be expected in the first half of 2025
NEW HAVEN, Conn., Dec. 12, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (NASDAQ: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the positive outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in IPF patients with chronic cough, which requires no change to the current sample size for the trial (N=160). The trial has reached 75% of the targeted enrollment, and topline results from the full trial continue to be expected in the first half of 2025.
Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)" alt="Trevi Therapeutics, Inc. www.trevitherapeutics.com (PRNewsfoto/Trevi Therapeutics, Inc.)">
The SSRE analysis was conducted on the highest dose (108mg twice daily) in the trial after 50% of the initial targeted trial enrollment, or 80 patients, completed the six weeks of treatment. Based on the SSRE analysis, it was recommended that the CORAL trial should continue as planned to maintain the pre-specified conditional power of 80% or greater. The other two potential pre-specified outcomes of the SSRE analysis were an increase in the sample size or futility.
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