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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 (NASDAQ: TRVI) announced positive topline results from its Phase 2a RIVER trial evaluating Haduvio for refractory chronic cough (RCC). The trial met its primary endpoint with a 57% placebo-adjusted reduction in 24-hour cough frequency (p0.0001).Key findings include:
- 67% reduction in cough frequency from baseline
- 66% reduction in severe cough subgroup
- 68% reduction in moderate cough subgroup
- 84% of Haduvio patients achieved at least 30% reduction in cough frequency vs 29% for placebo
The trial involved 66 patients in a randomized, double-blind, placebo-controlled crossover study. Significant improvements were observed as early as Day 7 at the lowest dose (27mg BID). Common side effects included constipation, nausea, somnolence, headache, dizziness, and fatigue, with no serious adverse events reported.
Trevi Therapeutics (NASDAQ: TRVI) has scheduled a conference call and webcast for March 10th, 2025, at 8:30 a.m. ET to present topline results from their Phase 2a RIVER trial of Haduvio™. The trial evaluates oral nalbuphine ER for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
The presentation will include audio and slides, accessible via webcast. Participants can join by dialing (877) 870 4263 (domestic) or (412) 317 0790 (international). A 30-day replay will be available on the company's website after the event.
Trevi Therapeutics (Nasdaq: TRVI), focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatments, has announced its participation in three major investor conferences this March.
The schedule includes:
- TD Cowen 45th Annual Health Care Conference (March 3-5) in Boston, featuring a corporate presentation on March 4 at 10:30 AM ET by CFO Lisa Delfini and CCO Farrell Simon
- Leerink Partners Global Healthcare Conference (March 10-12) in Miami, with a presentation on March 12 at 8:00 AM ET by CEO Jennifer Good and CDO James Cassella
- Leerink Partners Mountain Meeting (March 23-26) in Jackson Hole, with CFO Lisa Delfini representing
All events will feature corporate presentations available to in-person attendees.
Trevi Therapeutics (NASDAQ: TRVI) has completed enrollment in its Phase 2b CORAL trial of Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Topline results are expected in the first half of 2025.
The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in approximately 160 IPF patients with chronic cough over a 6-week period. The study includes a 2-week titration period followed by 4 weeks of fixed dosing.
The primary endpoint measures the relative change in 24-hour cough frequency at Week 6 versus baseline, using an objective cough monitor. Secondary endpoints include patient-reported outcome measures for cough.
According to James Cassella, Chief Development Officer, chronic cough significantly impacts IPF patients, and current treatments are often ineffective, creating a substantial unmet need. Results will help determine optimal doses for the pivotal Phase 3 program.
Trevi Therapeutics (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, has announced its participation in three major investor conferences this February. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will be represented by key executives at these events.
The conferences include the Piper Sandler Biopharma Mogul Summit (February 2-4) in Park City, Utah, where CFO Lisa Delfini will attend; the Oppenheimer Healthcare 2025 Winter CEO & Investor Summit (February 3-6) in Vail, Colorado, featuring CEO Jennifer Good; and the Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conference (February 11-12), where Jennifer Good and Chief Development Officer James Cassella will deliver a corporate presentation on February 11 at 9:20 AM ET.
Trevi Therapeutics (NASDAQ: TRVI) provided key updates on its clinical trials and financial position. The company completed patient visits for its Phase 2a RIVER trial in refractory chronic cough (RCC), with topline results expected in Q1 2025. The Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough is approximately 80% enrolled, with results anticipated in H1 2025.
The company recently announced positive outcomes from both the sample size re-estimation analysis of the Phase 2b CORAL trial and their Human Abuse Potential study. Trevi's preliminary estimate indicates cash, cash equivalents, and marketable securities of $107.6 million as of December 31, 2024, providing runway into H2 2026.
Trevi Therapeutics (TRVI) has announced the pricing of an underwritten offering of 12,500,000 shares of common stock at $4.00 per share, aiming to raise $50 million before deducting underwriting costs. The offering, expected to close on December 17, 2024, includes participation from notable investors such as Adage Capital Partners LP, Frazier Life Sciences, and Vivo Capital.
The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis and refractory chronic cough, is conducting the offering through a shelf registration statement previously filed with the SEC. Leerink Partners, Stifel, and Oppenheimer & Co. are serving as joint book-running managers.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from its planned sample size re-estimation (SSRE) for the Phase 2b CORAL trial, confirming no changes needed to the current sample size of 160 patients. The trial, testing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) patients, has reached 75% enrollment, with topline results expected in H1 2025.
The SSRE analysis, conducted on the highest dose (108mg twice daily) after 80 patients completed treatment, supported maintaining the pre-specified conditional power of 80% or greater. The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in IPF patients with chronic cough, with the primary endpoint measuring relative change in 24-hour cough frequency.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from their human abuse potential (HAP) study of oral nalbuphine. The study demonstrated statistically significant lower 'Drug Liking' for clinical doses (81mg and 162mg) compared to 6mg IV butorphanol. The primary endpoint measured peak effect for 'Drug Liking' on a 100-point visual analog scale.
Key findings showed mean Emax 'Drug Liking' scores of 71.2 and 74.5 for 81mg and 162mg oral nalbuphine respectively, compared to 82.3 for butorphanol (p0.0001 and p=0.0008). Secondary endpoints were consistent with primary findings. The supratherapeutic dose (486mg) showed numerically lower but not statistically significant results. No serious adverse events were reported.
Trevi Therapeutics (Nasdaq: TRVI) announced its participation in the Piper Sandler 36th Annual Healthcare Conference, scheduled for December 3-5 in New York. Jennifer Good, President and CEO, will deliver a corporate presentation on December 4, 2024, at 1:00 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will also have its CEO and CFO participate in investor meetings during the event. The presentation and meetings will be accessible to in-person attendees.