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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 (NASDAQ: TRVI) announced participation in several investor events in May 2023. The events include the Aegis Virtual Conference from May 2-4, where senior management will present on May 3, and the American Thoracic Society's Respiratory Innovation Summit from May 19-20, with a presentation on May 20. Additionally, Trevi will be featured at the Yale Innovation Summit from May 31 to June 1. The focus of Trevi Therapeutics is on Haduvio™, an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and other conditions. Haduvio aims to provide a novel treatment through an oral formulation of nalbuphine. Trevi's leadership, including President and CEO Jennifer Good, will address investors at these key events.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced participation in the 22nd Annual Needham Virtual Healthcare Conference on April 17, 2023, at 11:00 a.m. ET. Key executives, including Jennifer Good (CEO), Lisa Delfini (CFO), and David Clark (CMO), will engage in a fireside chat. They will also hold investor meetings during the conference. Trevi is developing the investigational therapy Haduvio™ (oral nalbuphine ER) for chronic cough related to idiopathic pulmonary fibrosis and prurigo nodularis. A live webcast will be available on the company's website, with an archived replay accessible for 30 days post-event. Haduvio is a mixed receptor agonist and antagonist, targeting cough mediation. Safety and efficacy evaluations are pending regulatory review.
Trevi Therapeutics (TRVI) announced its fourth quarter and full-year 2022 financial results, reporting a net loss of $5.5 million for Q4, down from $8.5 million in Q4 2021. Total operating expenses decreased to $6.7 million, driven by lower R&D costs of $4.3 million. As of December 31, 2022, Trevi had $120.5 million in cash and marketable securities, which supports operations into 2026. The company plans multiple trial initiations for its investigational therapy Haduvio in chronic cough and prurigo nodularis in 2023, with FDA discussions ongoing. The full data from the Phase 2b/3 PRISM trial is expected in Q2 2023.
Trevi Therapeutics (Nasdaq: TRVI) announced a conference call scheduled for March 16, 2023, at 4:30 p.m. ET to discuss its fourth quarter and full-year financial results for 2022. The company, focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough associated with idiopathic pulmonary fibrosis (IPF) and prurigo nodularis, encourages participation via phone or webcast. Haduvio is a mixed μ-opioid receptor antagonist and κ-opioid receptor agonist, with safety and efficacy not yet evaluated by regulatory authorities. More information can be accessed from their official website.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) announced a key milestone on March 7, 2023, as the USPTO granted a notice of allowance for the patent covering its investigational therapy Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). This patent is expected to be Orange Book-listable with an expiration in 2039, enhancing Trevi's intellectual property portfolio. Currently, there are no approved treatments for chronic cough in IPF, affecting approximately 140,000 patients in the U.S. Haduvio is a mixed opioid receptor therapy that aims to address this significant health issue.
Trevi Therapeutics (NASDAQ: TRVI) announced its participation in several upcoming conferences in March 2023. The events include the Frazier/Fenwick Winter Investor Event from March 7-10, the Oppenheimer 33rd Annual Healthcare Conference on March 13-15 with a corporate presentation on March 13 at 4:00 p.m. ET, and BIO-Europe Spring on March 20-22 (in-person) and March 28-30 (virtual). Trevi is focused on Haduvio™ (oral nalbuphine ER) for chronic cough treatment in adults with idiopathic pulmonary fibrosis and prurigo nodularis, reporting positive results from its Phase 2 CANAL trial.
Trevi Therapeutics (Nasdaq: TRVI) will present at the Emerging Growth Conference on February 22, 2023, at 10:50 a.m. ET. The presentation will focus on its investigational therapy Haduvio™ (oral nalbuphine ER) targeting chronic cough in adults with idiopathic pulmonary fibrosis (IPF) and prurigo nodularis. Senior leadership, including Jennifer Good, David Clark, and Farrell Simon, will engage in a Q&A session following the presentation. Interested parties can register for the event and access the live webcast on Trevi’s website, with an archived replay available post-event.
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