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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, Inc. (Nasdaq: TRVI) announced a conference call on March 17, 2022, at 4:30 p.m. ET to review its Q4 and full year 2021 financial results. The company is focused on developing Haduvio (nalbuphine ER) for treating serious conditions. Currently, Trevi is conducting Phase 2b/3 trials for chronic pruritus linked to prurigo nodularis and a Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis patients. Haduvio has been granted Fast Track designation by the FDA for its proposed use.
Trevi Therapeutics (TRVI) announced positive interim results from its Phase 2 CANAL trial of Haduvio in chronic cough patients with idiopathic pulmonary fibrosis (IPF). The trial showed a 52% placebo-adjusted reduction in daytime cough events, achieving statistical significance (p<0.0001). Based on these results, the company will halt recruitment and focus on advancing Haduvio into the next development phase. Trevi plans to report full trial data in Q3 2022, indicating a potential breakthrough for IPF patients suffering from chronic cough.
Trevi Therapeutics (Nasdaq: TRVI) announced the completion of enrollment for its Phase 2b/3 PRISM trial, which evaluates Haduvio™ (nalbuphine ER) for chronic pruritus associated with prurigo nodularis (PN). The company anticipates releasing top-line data in Q2 2022. The trial involves around 360 subjects and aims to establish the efficacy of Haduvio in providing relief from severe itching. The FDA has granted Fast Track designation for this investigational therapy, facilitating expedited development and review.
Trevi Therapeutics (TRVI) announced significant upcoming updates regarding its clinical trials. An interim statistical update for the Phase 2 CANAL trial, evaluating Haduvio for chronic cough in idiopathic pulmonary fibrosis (IPF) patients, is expected in Q1 2022. Additionally, enrollment in the Phase 2b/3 PRISM trial for pruritus related to prurigo nodularis will conclude by January 31, 2022. These trials are pivotal, as there are currently no approved treatments for these conditions, underscoring the urgent need for effective therapies.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, will participate in several virtual conferences in January 2022. These include the 11th Annual LifeSci Partners Corporate Access Event (Jan 5-7), Dermatology Summit (Jan 7), H.C. Wainwright BIOCONNECT (Jan 10-13), and Biotech Showcase 2022 (Jan 10-12, Jan 17-19). Jennifer Good, CEO, will join a panel discussing therapeutic development for itch at the Dermatology Summit. Trevi develops Haduvio™, an investigational therapy for serious conditions like chronic pruritus and chronic cough, with ongoing clinical trials for these indications.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced that Dr. Bill Forbes will present at the 5th Annual Dermatology Drug Development Summit on November 18, 2021, in Boston, MA. The presentation will focus on Nalbuphine ER, an investigational therapy aimed at treating pruritus associated with prurigo nodularis. Trevi is conducting Phase 2b/3 trials for Haduvio, targeting chronic conditions mediated through opioid receptors. Haduvio has received Fast Track designation from the FDA for its proposed use in reducing pruritus severity.
Trevi Therapeutics, Inc. (TRVI) reported its financial results for Q3 2021, highlighting a net loss of $7.3 million, a slight improvement from $7.4 million in Q3 2020. As of September 30, 2021, the company had cash and equivalents of $29.3 million. The Phase 2b/3 PRISM trial for Haduvio in chronic pruritus is 90% enrolled, with top-line data expected in 1H 2022. Additionally, Trevi raised $14.8 million post-quarter to support ongoing operations. The company emphasizes the large market potential for its investigational therapy targeting severe itch and chronic cough.
Trevi Therapeutics (Nasdaq: TRVI) announced that its senior leadership will participate in a virtual fireside chat and host investor meetings at the Stifel 2021 Virtual Healthcare Conference on November 15, 2021, with a presentation scheduled for 4 p.m. ET. The event will feature Jennifer Good (President and CEO), Lisa Delfini (CFO), and Bill Forbes (CDO). Investors can access a live webcast on Trevi's website, and an archived replay will be available for 30 days post-conference. Trevi is focused on developing Haduvio, an investigational therapy for serious neurologically mediated conditions.
Trevi Therapeutics (Nasdaq: TRVI) will host a conference call and live audio webcast on November 10 at 4:30 p.m. ET to discuss its Q3 2021 financial results and provide a corporate update. Trevi focuses on developing Haduvio™ (nalbuphine ER) for serious neurological conditions, conducting Phase 2b/3 trials for chronic pruritus and Phase 2 trials for chronic cough in idiopathic pulmonary fibrosis patients. Haduvio has received Fast Track designation by the FDA for prurigo nodularis, although its safety and efficacy are yet to be evaluated.
Trevi Therapeutics (Nasdaq: TRVI) announced that Dr. Bill Forbes, Chief Development Officer, will present at the 11th World Congress on Itch on October 22-23, 2021. The session will focus on the challenges in itch research and the drug development perspective. Trevi is developing Haduvio (nalbuphine ER) for serious neurologically mediated conditions, including chronic pruritus and chronic cough. Haduvio has received Fast Track designation from the FDA for prurigo nodularis. The company aims to address unmet medical needs in itch management.
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