Why Is Cough-Focused Trevi Therapeutics Stock Skyrocketing On Thursday?
Why Is Cough-Focused Trevi Therapeutics Stock Skyrocketing On Thursday?
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.On Thursday, Trevi Therapeutics, Inc. (NASDAQ:TRVI) announced the outcome from the planned sample size re-estimation (SSRE) for the ongoing Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough, which requires no change to the current sample size for the trial (N=160).
周四，Trevi Therapeutics, Inc. (纳斯达克:TRVI)宣布针对正在进行的20亿CORAL试验的样本量重新评估（SSRE）结果，该试验针对患有慢性咳嗽的特发性肺纤维化（IPF）患者，目前无需更改试验的样本量（N=160）。
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.
CORAL试验是一项双盲、随机、安慰剂对照的平行组试验，评估在有慢性咳嗽的IPF患者中，Haduvio（27mg，54mg和108mg每日两次）三种剂量与安慰剂的比较。
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 (VitaloJAK). The trial will also explore secondary endpoints, including patient-reported outcome measures for cough.
该试验的主要疗效终点是Haduvio与安慰剂相比，在第六周结束时与基线相比24小时咳嗽频率的相对变化，使用客观咳嗽监测仪（VitaloJAK）测量。试验还将探讨次要终点，包括患者报告的咳嗽结果指标。
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.
该试验已达到目标入组的75%，并且预计将在2025年上半年继续获得完整试验的初步结果。
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.
在最初目标试验入组的50%，即80名患者完成六周治疗后，SSRE分析是在试验的最高剂量（108mg每日两次）上进行的。
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.
基于SSRE分析，建议CORAL试验按照计划继续进行，以保持预先指定的80%或更大的条件功效。
The other two potential pre-specified outcomes of the SSRE analysis were increased sample size or futility.
SSRE分析的其他两个潜在预设结果是增加样本量或无效。
"We are pleased that the SSRE outcome supports the continued execution of the CORAL trial with the total number of patients as originally planned," said Jennifer Good, President and CEO of Trevi Therapeutics. "This positive SSRE outcome is reassuring and confirms the key powering assumptions of the trial design. We believe this is additional confirmation of the strong efficacy observed in the Phase 2a CANAL trial in IPF cough..."
Trevi Therapeutics的总裁兼首席执行官Jennifer Good表示：“我们很高兴SSRE结果支持按原计划继续进行CORAL试验的患者总数。这个积极的SSRE结果令人放心，并确认了试验设计的关键功效假设。我们相信这进一步确认了在IPF咳嗽的2a期CANAL试验中观察到的强效。”
Price Action: At last check Thursday, TRVI stock was up 71.50% at $4.27.
价格走势：在周四最后检查时，TRVI股票上涨了71.50%，达到4.27美元。
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译文内容由第三方软件翻译。
