Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization Haduvio to treat serious neurologically mediated conditions. It includes treatment of chronic pruritus associated with prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis, and levodopa-induced dyskinesia in patients with Parkinson’s disease. The company was founded by Thomas R. Sciascia and Jennifer L. Good in March 2011 and is headquartered in New Haven, CT.
相关临床试验
30
14 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2011
进行中（未招募）
14
46.7%
已完成
13
43.3%
招募中
2
6.7%
Unknown
1
3.3%
暂无批准数据
- Trevi Therapeutics has secured an FDA End-of-Phase 2 meeting scheduled for the first quarter of 2026 to discuss the regulatory pathway for Haduvio in treating chronic cough in idiopathic pulmonary fibrosis patients. - The company plans to initiate a Phase 3 program for chronic cough in IPF patients and a Phase 2b trial for refractory chronic cough, both in the first half of 2026. - Haduvio is the first investigational therapy to demonstrate statistically significant reduction in cough frequency across both IPF chronic cough and refractory chronic cough patient populations. - The therapy addresses significant unmet medical needs, with approximately 150,000 U.S. IPF patients and 2-3 million refractory chronic cough patients currently lacking FDA-approved treatments.
- Trevi Therapeutics reported a third quarter net loss of $11.8 million while advancing its chronic cough drug Haduvio toward Phase 3 clinical trials for multiple indications. - The company successfully completed a substantial funding round that extends its cash runway through 2028, addressing near-term liquidity concerns and supporting pivotal trial operations. - Trevi is actively engaging with the FDA to finalize pivotal trial design for chronic cough indications, including idiopathic pulmonary fibrosis and refractory chronic cough. - The strengthened financial position reduces dilution risks in the short term, though the company remains dependent on favorable regulatory feedback and successful late-stage clinical results.
- Trevi Therapeutics will present data from Phase 2a RIVER trial of nalbuphine ER for refractory chronic cough at the European Respiratory Society Congress 2025 through two poster presentations. - The company's Phase 2b CORAL trial results for chronic cough in idiopathic pulmonary fibrosis patients will be featured in an oral presentation at CHEST 2025 Annual Meeting. - Nalbuphine ER represents the first investigational therapy to demonstrate statistically significant reduction in cough frequency for both IPF chronic cough and refractory chronic cough patients. - The drug targets opioid receptors as a kappa agonist and mu antagonist, addressing conditions affecting approximately 2-3 million U.S. patients with refractory chronic cough and 150,000 patients with IPF.
- Stifel investment bank has increased its price target for Trevi Therapeutics (TRVI) from $8 to $12, maintaining a Buy rating as the company approaches key trial data readout. - Haduvio, Trevi's mixed opioid drug, has demonstrated effectiveness in treating idiopathic pulmonary fibrosis-related chronic cough (IPF-CC), a condition resistant to other treatments. - The company's Phase 2b study for Haduvio in IPF-CC patients continues on track, with topline data expected in the first half of 2025.
- Leerink Partners analyst maintains a Buy rating for Trevi Therapeutics with a $7.00 price target, citing Haduvio's potential in treating idiopathic pulmonary fibrosis (IPF) cough. - The upcoming Phase 2a RIVER study for refractory chronic cough (RCC) is anticipated to deliver positive results, potentially strengthening the company's market position. - IPF cough indication presents a clear commercial pathway with possible orphan drug designation, while expansion into RCC market faces competitive challenges requiring strong efficacy data.
- Trevi Therapeutics' Phase 2b CORAL trial evaluating Haduvio for chronic cough in IPF patients has reached 75% enrollment, indicating strong progress. - The trial, involving 160 patients across 10 countries, is assessing the efficacy of three Haduvio doses versus placebo over six weeks. - Top-line data from the CORAL trial is anticipated in the first half of 2025, offering hope for a potential first-in-class treatment. - A prior Phase 2a trial demonstrated Haduvio's significant reduction in cough frequency in IPF patients, supporting further investigation.
• Trevi Therapeutics' oral nalbuphine showed statistically significant lower "Drug Liking" compared to IV butorphanol in a human abuse potential (HAP) study. • The study assessed three doses of oral nalbuphine (81mg, 162mg, 486mg) against IV butorphanol and placebo in recreational drug users. • Secondary endpoints were consistent with the primary endpoint, with no serious adverse events reported during the study. • These results support nalbuphine's potential as a non-scheduled option for chronic cough without the abuse risks of traditional opioids.
- Trevi Therapeutics' Phase 2b CORAL trial for chronic cough in IPF reaches 50% enrollment; sample size re-estimation results are expected in December 2024. - Dosing is complete in the Human Abuse Potential (HAP) study for Haduvio, with topline results also anticipated in December 2024. - The Phase 2a RIVER trial for refractory chronic cough has reached its planned sample size, with topline results expected in Q1 2025.
