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Trevi Therapeutics, Inc. (Nasdaq: TRVI) is a late-stage biopharmaceutical company devoted to addressing chronic pruritic conditions and chronic cough through its investigational therapy, Haduvio™ (oral nalbuphine ER). Haduvio is an oral extended-release formulation of nalbuphine, a synthetic opioid with a dual mechanism of action: as a ĸ-opioid receptor agonist and µ-opioid receptor antagonist. This unique mechanism has shown promise in clinical trials for reducing symptoms associated with chronic cough, particularly in idiopathic pulmonary fibrosis (IPF), refractory chronic cough (RCC), and prurigo nodularis, a dermatologic condition characterized by pruriginous lesions.
Trevi is advancing various pruritic conditions through clinical development, including prurigo nodularis, which currently has no approved therapies in the US or EU. The company's lead indication involves extensive studies and trials, such as the recent Phase 2b/3 PRISM (Pruritus Relief through Itch-Scratch Modulation) trial, which demonstrated Haduvio's efficacy and safety over 52 weeks.
In the chronic cough segment, Trevi's Haduvio is undergoing trials like the Phase 2a RIVER study for RCC and the Phase 2b CORAL trial for chronic cough in IPF. The RIVER trial is a double-blind, placebo-controlled study evaluating Haduvio's impact on 24-hour cough frequency, while the CORAL trial investigates three dose levels of Haduvio against a placebo in IPF patients, assessing endpoints like cough frequency reduction and quality of life improvements.
Trevi's innovative approach aims to provide relief where current treatments fail, supported by promising clinical data and ongoing trials. The company's commitment to addressing unmet medical needs is reflected in its thorough and transparent communication with investors and stakeholders, ensuring that all developments are promptly shared, including financial results and future plans.
For more detailed information on Trevi Therapeutics, its clinical trials, and its forward-looking statements, visit TreviTherapeutics.com and follow the company on Twitter and LinkedIn.
Trevi Therapeutics (TRVI) reported updates on its clinical trials and financial results for Q3 2020. The PRISM trial for Haduvio, targeting severe pruritus, has surpassed halfway enrollment with approximately 190 subjects. The company aims to complete enrollment by Q3 2021 and report data by Q4 2021. In a phase 2 trial for chronic cough in IPF, new patient enrollment has resumed post COVID-19. As of September 30, 2020, Trevi's cash position was $53.3 million, expected to fund operations into H1 2022, with a Q3 net loss of $7.4 million.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced its participation in the Stifel 2020 Virtual Healthcare Conference on November 17, 2020, at 10:00 a.m. ET. The management will provide a company overview and conduct virtual investor meetings. Interested parties can access a live webcast of the presentation on Trevi's website, with an archived replay available for 30 days post-conference. Trevi Therapeutics focuses on developing Haduvio™, an investigational oral formulation of nalbuphine, aimed at treating serious neurologically mediated conditions like chronic pruritus.
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.
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