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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 its participation in the Alliance Global Partners' Virtual Biotech & Specialty Pharma Conference on October 13, 2021. The company focuses on the development of Haduvio (nalbuphine ER) to treat serious neurologically mediated conditions. Currently, Trevi is conducting a Phase 2b/3 clinical trial for chronic pruritus related to prurigo nodularis and a Phase 2 trial for chronic cough in idiopathic pulmonary fibrosis patients. The investigational therapy has received Fast Track designation from the FDA for moderate to severe pruritus reduction.
Trevi Therapeutics (TRVI) announced a private placement with a healthcare-focused institutional investor, raising approximately $11.8 million. The agreement involves the sale of 2,373,201 shares of common stock and accompanying warrants, priced at $1.62 per share, as well as pre-funded warrants. The company plans to use the proceeds to advance its investigational therapy, Haduvio™, targeting neurologically mediated conditions such as chronic pruritus and chronic cough. The private placement is expected to close on October 4, 2021.
Trevi Therapeutics (Nasdaq: TRVI) reported Q2 2021 financial results, revealing a net loss of $9.8 million, a significant increase from a net loss of $7.4 million in Q2 2020. As of June 30, 2021, Trevi had $36.4 million in cash, down from $45.0 million at the end of 2020. Approximately 80% of participants have enrolled in the Phase 2b/3 PRISM trial for Haduvio, with top-line data expected in 1H 2022. The company is also progressing in its CANAL trial for chronic cough, and recently expanded its management team.
Trevi Therapeutics (Nasdaq: TRVI) has appointed Lisa Delfini as Chief Financial Officer and Danine Summers as Vice President of Medical Affairs. Delfini, with 30 years of experience, will oversee financial operations and capital activities. Summers, an accomplished Medical Affairs executive, will focus on educating healthcare professionals regarding Haduvio’s data and development. Both appointments are expected to strengthen Trevi's leadership as it advances its Phase 2b/3 PRISM trial and Phase 2 CANAL trial for Haduvio, aimed at treating serious neurologically mediated conditions.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) will host a conference call and audio webcast on August 12, 2021, at 4:30 p.m. ET to discuss its financial results for the quarter ending June 30, 2021 and provide a corporate update. The company is focused on developing Haduvio (nalbuphine ER) for serious neurologically mediated conditions, currently conducting Phase 2b/3 clinical trials for chronic pruritus associated with prurigo nodularis and Phase 2 trials for chronic cough in idiopathic pulmonary fibrosis patients.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced that CEO Jennifer Good will present at the 2021 BIO Digital conference on June 10-11 and June 14-18. Haduvio™ (nalbuphine ER), Trevi's investigational therapy for serious neurologically mediated conditions, is currently undergoing Phase 2b/3 trials for chronic pruritus and Phase 2 trials for chronic cough. The presentation is available to registered attendees from 9am ET June 10 until the conference ends on June 18, with an archived replay accessible for 30 days via Trevi's website.
Trevi Therapeutics (Nasdaq: TRVI) reported its Q1 2021 financial results on May 13, 2021, highlighting key advancements in its clinical trials. The company has enrolled approximately 255 subjects in the PRISM trial for moderate to severe pruritus in prurigo nodularis and received FDA Fast Track designation for this indication. With a cash position of $41.6 million, Trevi expects to fund operations through Q2 2022. The net loss reported for Q1 2021 was $8.4 million, a slight decrease compared to $8.5 million in the same period last year.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) will host a conference call on May 13, 2021, at 4:30 p.m. ET to discuss its Q1 2021 financial results and provide a corporate update. The company is developing Haduvio™ (nalbuphine ER) for serious neurologically mediated conditions, including chronic pruritus associated with prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis patients. Haduvio is currently undergoing Phase 2b/3 clinical trials. An archived replay of the conference call will be available on Trevi's website.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) will participate in the 20th Annual Needham Virtual Healthcare Conference on April 14, 2021, with a presentation at 2:15 p.m. ET. The company focuses on developing Haduvio™ (nalbuphine ER) for serious neurologically mediated conditions. Investors can access a live webcast on the company's website, along with an archived replay available for 30 days post-conference. Trevi is conducting clinical trials for Haduvio targeting chronic pruritus, chronic cough in idiopathic pulmonary fibrosis, and levodopa-induced dyskinesia.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced its Q4 2020 and annual financial results, reporting a net loss of $9.5 million for Q4 and $32.8 million for the year. R&D expenses rose to $22.3 million, driven by clinical trial activities. The company is progressing in its Phase 2b/3 PRISM trial, expecting to complete enrollment of 360 subjects by Q3 2021, with top-line data anticipated in Q4 2021. As of December 31, 2020, Trevi had $45 million in cash, expected to fund operations into Q2 2022.
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