业绩总结 - Haduvio在IPF患者中实现了显著的疗效，108 mg BID剂量组相较基线的变化为-60.2%（p<0.0001）[12] - 54 mg BID剂量组的基线变化为-53.4%（p<0.0001），27 mg BID剂量组为-47.9%（p<0.01）[12] - 大多数Haduvio患者的客观咳嗽频率减少超过50%[12] - 试验显示，Haduvio在第2周就开始显著降低咳嗽频率[12] - 试验的主要终点是第6周相较安慰剂的24小时咳嗽频率的相对变化[26] 用户数据 - 85%的IPF患者存在慢性咳嗽，且该病患者的预期寿命为3-5年[11] - 该研究为多中心随机、双盲、安慰剂对照的4组剂量范围研究，共有165名患者参与[30] - 在54 mg BID和108 mg BID剂量组中观察到咳嗽严重程度的统计学显著降低[46] - 54 mg BID组和108 mg BID组的患者报告的咳嗽频率相较于基线的平均绝对变化分别为-3.17和-3.00[47] - 54 mg BID组和108 mg BID组的患者在基线时的咳嗽频率分别为6.79和6.60[47] 安全性与不良事件 - Haduvio的安全性与之前的研究一致，因不良事件导致的停药率在Haduvio组为5.6%，安慰剂组为5.0%[12] - 试验中未发生死亡事件，安慰剂组的严重不良事件发生率为10%，而活性剂量组为1.6%[48] - 治疗相关的不良事件在安慰剂组和活性剂量组的分布相似，分别为5.0%和5.6%[48] - 在活性剂量组中，恶心的发生率为33.6%，呕吐为20.8%[51] 未来展望 - 公司计划在2025年下半年请求FDA进行阶段2结束会议，并在2026年上半年启动阶段3研究[12] - Haduvio在IPF慢性咳嗽患者中显示出显著的剂量相关咳嗽频率降低[54] - 预计将在2025年下半年请求与FDA的阶段2结束会议，并准备启动阶段3项目[74] - 目前美国没有FDA批准的治疗IPF患者慢性咳嗽的疗法[64]

Haduvio met the primary endpoint with statistically-significant reductions in 24-hour cough frequency across all dose groups (108 and 54 mg BID p<0.0001; 27 mg BID p<0.01); a -43.3% placebo-adjusted change from Baseline was achieved at the 108 mg BID dose group  Patients saw a rapid reduction in 24-hour cough frequency at Week 2, the first time point measuredHaduvio was generally well-tolerated at all doses; discontinuation rates due to adverse events were similar in the Haduvio and placebo groups, 5.6% and ...

公司动态 - 公司将于2025年6月2日美国东部时间上午8:30举行电话会议和网络直播，分享Haduvio™在特发性肺纤维化(IPF)慢性咳嗽患者中的2b期CORAL试验的顶线结果 [1] - 电话会议可通过拨打电话(877) 870 4263(美国国内)或(412) 317 0790(国际)参与，无需接入码 [2] - 网络直播将包含音频和演示幻灯片，活动结束后30天内可在公司网站观看回放 [2] 产品研发 - Haduvio™(口服纳布啡缓释剂)是公司正在研发的用于治疗IPF慢性咳嗽和难治性慢性咳嗽(RCC)的研究性疗法 [4] - Haduvio™是目前唯一在IPF慢性咳嗽和RCC患者临床试验中显示出咳嗽频率统计学显著降低的研究性疗法 [4] - Haduvio™作为κ激动剂和μ拮抗剂(KAMA)，通过作用于咳嗽反射弧的中枢和外周，靶向在控制慢性咳嗽中起关键作用的阿片受体 [4] - 纳布啡目前未被美国缉毒局列为管制药物 [4] 疾病背景 - 慢性咳嗽在IPF患者中非常普遍，影响高达85%的IPF人群 [3] - 美国约有140,000名IPF患者 [3] - IPF慢性咳嗽患者每天咳嗽次数可达1,500次，严重影响患者的社会、身体和心理生活质量 [3] - 目前尚无获批的治疗IPF慢性咳嗽的疗法，现有的超说明书用药方案对患者益处有限 [3]

NEW HAVEN, Conn., May 29, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced that senior management will be participating in the following conferences in June.American Cough ConferenceJune 6 – 7, 2025, Dulles, VirginiaOral Presentat ...

NEW HAVEN, Conn., May 20, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and in patients with refractory chronic cough (RCC), today announced additional analyses from the Phase 2a RIVER trial of Haduvio for the treatment of patients with RCC (N=66). In March 2025, the Company announced positive t ...

Trevi Therapeutics Inc (TRVI) Q1 2025 Earnings Call May 08, 2025 04:30 PM ET Speaker0 Good afternoon, and welcome to the Trevy Therapeutics First Quarter twenty twenty five Earnings Conference Call. At this time, all participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. Various remarks that management makes during this conference call about the company's future expectations, plans and prospects constitut ...

Trevi Therapeutics Inc (TRVI) Q4 2024 Earnings Call March 18, 2025 04:30 PM ET Company Participants Jennifer Good - Co-Founder, CEO, President & DirectorLisa Delfini - Chief Financial OfficerMayank Mamtani - Senior Managing DirectorAnnabel Samimy - Managing DirectorRyan Deschner - Vice President - Equity ResearchBrandon Folkes - Managing Director - Equity Research Conference Call Participants None - AnalystLeland Gershell - MD & Senior Biotechnology AnalystSerge Belanger - Senior Analyst Operator Good after ...