Conference call and webcast to be held at 4:30 p.m. ETNEW HAVEN, Conn., March 11, 2025 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will host a conference call and live audio webcast on Tuesday, March 18, 2025, at 4:30 p.m. E ...

On Monday, Trevi Therapeutics, Inc. TRVI reported topline results from its Phase 2a RIVER trial of Haduvio (oral nalbuphine ER) for the treatment of patients with refractory chronic cough (N=66).Haduvio met the primary endpoint with a statistically significant reduction in the objective 24-hour cough frequency of 67% from baseline and 57% on a placebo-adjusted basis.Haduvio demonstrated a statistically significant reduction in 24-hour cough frequency of 66% in the severe cough (20+ coughs/hour) subgroup and ...

Haduvio met the primary endpoint with a statistically-significant reduction (p<0.0001) in 24-hour cough frequency with a 57% placebo-adjusted change from baseline Haduvio showed similar efficacy in patients with moderate or severe cough counts (p<0.0001) Haduvio is the first and only therapy to show a statistically-significant reduction in chronic cough across both RCC and IPF patientsPatient reported and other secondary outcomes were statistically significant and consistent with the primary endpointCompany ...

Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [4][6] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [4] Industry Context - Refractory chronic cough (RCC) affects approximately 2-3 million patients in the U.S. and has no approved therapies, defined as a cough lasting over 8 weeks despite treatment for underlying conditions [3] - Chronic cough is prevalent in IPF patients, impacting up to 85% of this population, with around 140,000 IPF patients in the U.S. [5] - The condition can lead to significant social and economic burdens, including sleep disruption and social embarrassment [3] Upcoming Events - The company will hold a conference call and live webcast on March 10, 2025, at 8:30 a.m. ET to share topline results from the Phase 2a RIVER trial of Haduvio in patients with RCC [1][2]

Core Insights - Trevi Therapeutics, Inc. is focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5][6][7] - The company will participate in several investor conferences in March 2025 to present its corporate strategy and updates [2][3][4] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company [5] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [5] - Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency [5] Market Context - Chronic cough affects up to 85% of the 140,000 U.S. IPF patients, with patients coughing up to 1,500 times daily, leading to significant health complications [6] - There are no approved therapies for chronic cough in IPF patients, and current off-label treatments offer minimal benefits [6] - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing various complications and significant social and economic burdens [7]

Core Insights - Trevi Therapeutics has completed enrollment in its Phase 2b CORAL trial for Haduvio, targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF), with topline results expected in the first half of 2025 [1][2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER) for chronic cough in IPF and refractory chronic cough (RCC) [5] - Haduvio functions as a kappa agonist and mu antagonist, acting on the cough reflex arc to manage cough hypersensitivity [5] Clinical Trial Details - The CORAL trial is a double-blind, randomized, placebo-controlled study evaluating three doses of Haduvio (27mg, 54mg, and 108mg) against placebo over a 6-week period, involving approximately 160 IPF patients [3] - The primary efficacy endpoint is the relative change in 24-hour cough frequency at the end of Week 6 compared to baseline, measured with an objective cough monitor [3] Market Need - Chronic cough affects up to 85% of the IPF population, with around 140,000 IPF patients in the U.S., leading to significant health impacts and a high frequency of coughing [4] - There are currently no approved therapies for chronic cough in IPF patients, highlighting a substantial unmet medical need [4] Refractory Chronic Cough Context - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing various complications and significant social and economic burdens [6]

Core Insights - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [3][4]. Company Overview - Trevi Therapeutics is developing Haduvio™, which acts as a kappa agonist and mu antagonist (KAMA) targeting cough hypersensitivity through opioid receptors [3]. - The investigational therapy is not currently scheduled by the U.S. Drug Enforcement Agency [3][6]. Market Need - Chronic cough affects up to 85% of the 140,000 U.S. patients with IPF, leading to severe impacts on quality of life and potential disease progression [4]. - There are no approved therapies for chronic cough in IPF, and current off-label treatments offer minimal benefits [4]. - Refractory chronic cough impacts approximately 2-3 million adults in the U.S., causing significant social and economic burdens [5]. Upcoming Events - Trevi's senior management will attend several investor conferences in February 2025, including: - Piper Sandler Biopharma Mogul Summit (February 2-4, 2025) [2] - Oppenheimer Healthcare 2025 Winter CEO & Investor Summit (February 3-6, 2025) [2] - Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conference (February 11-12, 2025) with a corporate presentation on February 11 [2].

Core Viewpoint - Trevi Therapeutics, Inc. (TRVI) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - For the fiscal year ending December 2024, Trevi Therapeutics is expected to earn -$0.49 per share, reflecting a 69% decrease from the previous year's reported number [9]. - Over the past three months, the Zacks Consensus Estimate for Trevi Therapeutics has increased by 0.7%, indicating a positive trend in earnings estimates [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, as shown by earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which subsequently affects stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Trevi Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [11].

Core Viewpoint - Trevi Therapeutics, Inc. has announced a public offering of 12,500,000 shares of its common stock at a price of $4.00 per share, aiming to raise total proceeds of $50 million before expenses [1] Group 1: Offering Details - The offering is fully underwritten and is expected to close on December 17, 2024, subject to customary closing conditions [1] - The shares are being sold under a shelf registration statement filed with the SEC, which was declared effective on August 15, 2023 [3] - The final terms of the offering will be disclosed in a prospectus supplement to be filed with the SEC [3] Group 2: Investor Participation - The financing includes participation from both new and existing investors, such as Adage Capital Partners LP, Frazier Life Sciences, and others [2] - Leerink Partners, Stifel, and Oppenheimer & Co. are acting as joint book-running managers for the offering, with Needham & Company as the lead manager [2] Group 3: Company Overview - Trevi Therapeutics is a clinical-stage biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC) [5] - Haduvio acts on the cough reflex arc as a kappa agonist and mu antagonist, targeting opioid receptors involved in cough hypersensitivity [5]

Core Viewpoint - Trevi Therapeutics announced positive results from a human abuse potential study of oral nalbuphine, indicating lower "Drug Liking" compared to butorphanol, supporting its potential as a treatment for chronic cough in idiopathic pulmonary fibrosis and refractory chronic cough [1][2][5]. Study Results - The HAP study was a randomized, double-blind, placebo-controlled trial involving recreational drug users, assessing the peak effect for "Drug Liking" on a 100-point visual analog scale [2][8]. - Statistically significant lower "Drug Liking" was observed for oral nalbuphine doses of 81mg and 162mg compared to 6mg IV butorphanol, with p-values of p<0.0001 and p=0.0008 respectively [3]. - The mean Emax for "Drug Liking" was 71.2 for 81mg and 74.5 for 162mg oral nalbuphine, compared to 82.3 for butorphanol [3]. Secondary Endpoints - Secondary endpoints showed that oral nalbuphine also had higher scores for "Take Drug Again" and lower scores for "I Feel High" and "I Feel Good" compared to butorphanol, indicating a favorable profile [4]. - No serious adverse events were reported during the study, reinforcing the safety profile of oral nalbuphine [4]. Company Insights - Trevi Therapeutics is focused on developing Haduvio (oral nalbuphine ER) for chronic cough in patients with idiopathic pulmonary fibrosis and refractory chronic cough, addressing significant unmet medical needs [1][9]. - The company plans to report data from ongoing studies for chronic cough, emphasizing the potential of nalbuphine to meet health needs without the risks associated with traditional opioids [5][6]. Market Context - Chronic cough affects approximately 140,000 patients with idiopathic pulmonary fibrosis in the U.S., with a significant percentage experiencing debilitating symptoms [10]. - Refractory chronic cough impacts 2-3 million adults in the U.S., leading to various complications and a lack of approved therapies [11].