Trevi Therapeutics, Inc. reports news on its clinical-stage biopharmaceutical development of Haduvio, an oral extended-release formulation of nalbuphine, for chronic cough in patients with idiopathic pulmonary fibrosis, non-IPF interstitial lung disease, and refractory chronic cough. Company updates commonly cover clinical trial results and plans, FDA interactions, medical-conference presentations, intellectual property, and the investigational status of Haduvio.
Trevi also reports financing and corporate updates tied to its development strategy, including common stock offerings, quarterly financial results, cash runway commentary, and participation in healthcare investor events.
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 (p0.0001). 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 (p0.0001). 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.