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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), a clinical-stage biopharmaceutical company, will present at two significant events in May 2022. The LifeSci Partners Immunology & Inflammation Symposium is scheduled for May 11, featuring Jennifer Good (President and CEO) and Dr. Bill Forbes (CDO). Additionally, Trevi will participate in the H.C. Wainwright Global Investment Conference from May 23-26, with a virtual presentation on May 24. Trevi is developing Haduvio (nalbuphine ER) for treating chronic pruritus in prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, will participate in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, from 10:15 a.m. to 10:55 a.m. EDT. CEO Jennifer Good and Dr. Bill Forbes will discuss the investigational therapy Haduvio for treating pruritus in prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis. The event will be available via live webcast on the company’s website, with an archived replay accessible for 30 days.
Trevi recently reported significant results from its CANAL trial, showing a 77% reduction in daytime cough frequency.
Trevi Therapeutics (Nasdaq: TRVI) announced a private placement to raise approximately $55 million through the sale of 4,580,526 shares at $1.90 each and pre-funded warrants at $1.899. The funds will support the clinical development of Haduvio for chronic cough in idiopathic pulmonary fibrosis (IPF) and for working capital. The deal, led by Frazier Life Sciences and Venrock Healthcare Capital Partners, is expected to close around April 11, 2022, pending customary conditions. The shares are unregistered under the Securities Act and will be resold upon effective registration.
Trevi Therapeutics (TRVI) announced its participation in the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022. The fireside chat, featuring CEO Jennifer Good and CDO Bill Forbes, will take place from 8:00 a.m. to 8:40 a.m. EDT. The discussion will highlight findings from the Phase 2 CANAL trial, where Haduvio showed a 77% reduction in daytime cough frequency in patients with idiopathic pulmonary fibrosis. Additionally, top-line data from the Phase 2b/3 PRISM trial for pruritus in prurigo nodularis is anticipated in the second quarter of 2022.
Trevi Therapeutics (TRVI) announced a webinar on March 30, 2022, focusing on chronic cough in idiopathic pulmonary fibrosis (IPF) patients. Dr. William Forbes will discuss the challenges faced by IPF patients, including a lack of approved treatments for chronic cough, which affects up to 85% of the 130,000 estimated US patients. Trevi will present recent positive interim results from its Phase 2 CANAL trial of Haduvio (nalbuphine ER) aimed at addressing chronic cough in IPF. The webinar will also include a live Q&A session.
Trevi Therapeutics (Nasdaq: TRVI) has announced significant updates regarding its clinical trials and financial performance. The Phase 2 CANAL trial for Haduvio™ in treating chronic cough in idiopathic pulmonary fibrosis (IPF) showed a highly significant reduction in cough events (p < 0.0001), leading to early enrollment closure. Additionally, enrollment in the Phase 2b/3 PRISM trial for pruritus due to prurigo nodularis is complete, with top-line results expected by Q2 2022. For Q4 2021, Trevi reported a net loss of $8.5 million and had cash reserves of $36.8 million as of December 31, 2021.
Trevi Therapeutics concludes early enrollment for its Phase 2 CANAL trial, focusing on chronic cough in idiopathic pulmonary fibrosis (IPF). The trial's interim analysis revealed a statistically significant 77.3% reduction in daytime cough frequency with Haduvio™ (nalbuphine ER) compared to 25.7% with placebo (p<0.0001). A total of approximately 40 subjects were enrolled. Full efficacy and safety results are anticipated in Q3 2022, following the successful interim findings.
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.
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