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Trevi Therapeutics, Inc. reports news on its clinical-stage biopharmaceutical development of Haduvio, an oral extended-release formulation of nalbuphine, for chronic cough in patients with idiopathic pulmonary fibrosis, non-IPF interstitial lung disease, and refractory chronic cough. Company updates commonly cover clinical trial results and plans, FDA interactions, medical-conference presentations, intellectual property, and the investigational status of Haduvio.
Trevi also reports financing and corporate updates tied to its development strategy, including common stock offerings, quarterly financial results, cash runway commentary, and participation in healthcare investor events.
Trevi Therapeutics (Nasdaq: TRVI) announces a conference call on November 11, 2020, at 4:30 p.m. ET to discuss Q3 2020 financial results and provide a corporate update. The call can be accessed by phone or via a live audio webcast on the company's website. Haduvio™ (nalbuphine ER), the company's lead drug, is being developed for serious neurologically mediated conditions, including chronic pruritus and levodopa-induced dyskinesia. Currently, Trevi is conducting a Phase 2b/3 trial, PRISM, for patients with severe pruritus.
Trevi Therapeutics, Inc. (TRVI) has resumed patient screening for its Phase 2 trial of Haduvio for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) after a pause due to COVID-19. The trial aims to enroll 60 subjects and investigate the efficacy of nalbuphine ER in reducing cough frequency. Additionally, the Phase 2b/3 PRISM trial for Haduvio in severe pruritus has reached 50% enrollment, with expectations to finish by Q3 2021 and report data by Q4 2021. The regulatory approval for protocol amendments enhances patient safety during the pandemic.
Trevi Therapeutics Updates Management Team
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced key appointments to enhance its clinical development and commercialization strategies for Haduvio™. Shashank Rohatagi, Ph.D. becomes Vice President of Pharmacology; Farrell Simon, Pharm.D. leads U.S. marketing; and Katherine S. Takaki, Ph.D. oversees global regulatory affairs. Dr. Rohatagi brings extensive regulatory experience, Dr. Simon has a strong commercial background from Pfizer, and Dr. Takaki has a proven record in regulatory strategy. Together, they aim to advance Haduvio’s development for serious conditions.
Trevi Therapeutics, a clinical-stage biopharmaceutical company focused on Haduvio (nalbuphine ER), announced its presentation at the 2020 H.C. Wainwright Global Investment Conference on September 16, 2020, at 3:00 p.m. ET. The presentation will outline the company’s development of Haduvio for conditions like chronic pruritus and chronic cough. A live webcast will be available on their website, with an archived version accessible for 30 days.
Trevi Therapeutics (Nasdaq: TRVI) announced a positive outcome in its PRISM trial following a sample size re-estimation, increasing target enrollment from 240 to 360 subjects. With COVID-19 restrictions lifted, patient enrollment has accelerated, and approximately 155 subjects have been recruited. The company secured a $14 million term loan to support operations into the first half of 2022. For Q2 2020, Trevi reported a net loss of $7.4 million, with cash and cash equivalents at $44.2 million, down from $57.3 million at year-end 2019.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) will participate in the virtual 2020 BTIG Biotechnology Conference on August 10, 2020. Management will engage in a fireside chat at 11:00 a.m. ET, and virtual investor meetings will be hosted. Attendees can access a live webcast on the company’s website, with an archive available for 30 days post-conference. Trevi focuses on developing Haduvio™ (nalbuphine ER) for treating chronic pruritus, chronic cough in idiopathic pulmonary fibrosis patients, and levodopa-induced dyskinesia. Currently, it is in a Phase 2b/3 clinical trial for severe pruritus.
Trevi Therapeutics (Nasdaq: TRVI) has announced the recommendation from its Data Monitoring Committee to continue the PRISM trial for Haduvio (nalbuphine ER) with an expanded enrollment from 240 to 360 subjects. This decision follows a sample size re-estimation analysis, maintaining the trial's statistical power. Approximately 140 subjects have already enrolled, with completion expected by Q3 2021. Haduvio, aimed at treating severe pruritus in prurigo nodularis, shows promise as a treatment option and is not classified as a controlled substance in the U.S. and most of Europe.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced the election of Dominick C. Colangelo to its Board of Directors. Colangelo brings over 20 years of executive management experience, including leadership roles at Eli Lilly and as President of Vericel. His expertise in corporate development and product commercialization is expected to support Trevi's strategic initiatives. Trevi focuses on developing nalbuphine ER for conditions like chronic pruritus and levodopa-induced dyskinesia. The company is conducting a Phase 2b/3 PRISM trial for severe pruritus.
Trevi Therapeutics (Nasdaq: TRVI) announced that its management will present at the 2020 BMO Capital Markets Prescriptions for Success Healthcare Conference on June 23, 2020, at 11:30 a.m. ET. The event will include a virtual fireside chat and investor meetings. The company focuses on developing nalbuphine ER for treating serious conditions such as chronic pruritus and cough related to idiopathic pulmonary fibrosis. An archived webcast of the presentation will be available on the company's website for 30 days post-conference.