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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 plans to present its investigational therapy Haduvio™ at two major investor conferences in February 2023. The BIO CEO & Investor Conference will take place from February 6-9, with Trevi’s presentation scheduled for February 7 at 10:45 a.m. ET. The SVB Securities Global Biopharma Conference follows from February 13-16, where a presentation is set for February 14 at 11:20 a.m. ET. Trevi Therapeutics, trading under the symbol TRVI, is developing Haduvio for chronic cough and prurigo nodularis, having reported promising Phase 2 trial results for chronic cough in patients with idiopathic pulmonary fibrosis.
Trevi Therapeutics (Nasdaq: TRVI) announced significant business updates on Jan. 5, 2023, highlighting the progression of its investigational therapy, Haduvio™. Aiming to treat chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and prurigo nodularis, Trevi is preparing for several clinical studies in 2023, including a Phase 2 dose-ranging study and a Phase 1b respiratory physiology study. The company is also conducting a human abuse liability study and will request an End-of-Phase 2 meeting with the FDA. Trevi will participate in key conferences starting January 9, 2023.
Trevi Therapeutics (Nasdaq: TRVI) will present at the Biotech Showcase 2023 on January 10, 2023, at 3:00 p.m. PT. This event coincides with the 12th Annual LifeSci Partners Corporate Access Event, held from January 9-11, 2023, in San Francisco, CA. Trevi is focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough and prurigo nodularis. Positive results from the Phase 2 CANAL trial for chronic cough related to idiopathic pulmonary fibrosis have prompted Trevi to prioritize further clinical development in this area.
Trevi Therapeutics has appointed David Clark, MD, MRCP, as the new Chief Medical Officer to advance the development of Haduvio™, an oral investigational therapy for chronic cough related to idiopathic pulmonary fibrosis. Dr. Clark brings over 25 years of experience in clinical development and has previously led clinical teams at several biopharmaceutical companies. He will play a critical role in executing Trevi's clinical strategies, supported by the insights from prior CMO Thomas Sciascia, who transitions to Chief Science Officer.
Trevi Therapeutics (TRVI) reported its Q3 2022 financial results, highlighting a net loss of $8.3 million, up from $7.3 million year-over-year, largely due to increased R&D expenses of $5.8 million. The clinical-stage biopharmaceutical firm announced significant progress in its Phase 2 CANAL trial for Haduvio, showing a 75.1% reduction in cough frequency in IPF patients, backed by statistically significant data. Trevi ended the quarter with approximately $126 million in cash and equivalents, poised to fund further development.
Trevi Therapeutics (Nasdaq: TRVI) announced participation in the Stifel 2022 Healthcare Conference on November 16, 2022, from 3:35 p.m. to 4:05 p.m. EDT. CEO Jennifer Good and CFO Lisa Delfini will be present for a fireside chat discussing their investigational therapy Haduvio™ for chronic cough. A live audio webcast will be available on their website, with an archive accessible post-event. Trevi focuses on developing Haduvio, which has shown positive results in Phase 2 trials for chronic cough associated with idiopathic pulmonary fibrosis (IPF).
Trevi Therapeutics, a clinical-stage biopharmaceutical company, will host a conference call on November 10, 2022, at 4:30 p.m. ET to discuss its Q3 2022 financial results and provide a corporate update. The focus will be on its investigational therapy, Haduvio, for chronic cough conditions. The company has completed a Phase 2 trial for Haduvio's efficacy in treating chronic cough linked to idiopathic pulmonary fibrosis (IPF) and aims to target further development in chronic cough conditions including IPF and refractory chronic cough.
Trevi Therapeutics (Nasdaq: TRVI) announced statistically significant data from its Phase 2 CANAL trial of Haduvio (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF). The trial demonstrated a 76.1% reduction in 24-hour cough frequency for nalbuphine ER subjects versus 25.3% for placebo (p<0.0001). Key secondary endpoints also showed significant improvement. The results will be presented at the British Thoracic Society's Winter Meeting in London on November 23, 2022. Chronic cough affects over a million patients globally, highlighting the importance of effective treatments.
Trevi Therapeutics announced the pricing of its underwritten public offering of common stock and pre-funded warrants, aiming to raise approximately $50 million. The offering is led by SVB Securities, Stifel, and Oppenheimer & Co. and expected to close on September [__], 2022, pending customary conditions. The shares are sold under a shelf registration statement filed with the SEC. Trevi’s investigational therapy, Haduvio, addresses chronic cough in idiopathic pulmonary fibrosis and prurigo nodularis, with the offering intended to bolster its clinical development efforts.
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