Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023 [25] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [25][26] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in the same period in 2023, mainly due to increased stock-based compensation [26] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [26][27] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies on Human Abuse Potential, the CORAL study in chronic cough patients with IPF, and the RIVER study in patients with refractory chronic cough [6][20] - The RIVER trial met its primary endpoint with a statistically significant reduction in 24-hour objective cough frequency, achieving a p-value of less than 0.0001% [17] Market Data and Key Metrics Changes - The RIVER study targets a patient population of approximately 2 million to 3 million in the US suffering from refractory chronic cough, which currently has no approved therapies [16] - The company plans to focus on patients who have failed prior therapies, addressing a significant unmet need in the market [18] Company Strategy and Development Direction - The company aims to develop Haduvio as a first-in-class therapy for chronic cough conditions, with a focus on both IPF and RCC [23][24] - Plans include preparing for an End-of-Phase 2 meeting with the FDA by the end of 2025 to discuss pivotal program designs and safety databases [21] - The company intends to release more data from the RIVER trial at upcoming medical conferences, indicating a proactive approach to stakeholder engagement [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the potential of Haduvio to address significant unmet needs in chronic cough conditions [6][23] - The company remains optimistic about the upcoming data readouts and the potential for Haduvio to be positioned as a best-in-class therapy [23] Other Important Information - The company expects cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance to be updated as trial designs are finalized [28] - The current fully diluted shares outstanding are approximately 137 million, including about 10 million stock options [29] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in enrollment statistics [33][34] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management clarified that the study includes a two-week titration period, and previous studies indicated a placebo effect ranging from 15% to 23% [42][43] Question: How will the RCC patient population be split between P2X3 and Haduvio? - Management indicated that Haduvio would be positioned as a second or third-line therapy for patients who have failed P2X3 treatments, addressing a significant unmet need [46][48] Question: What exploratory metrics are expected at the time of the IPF chronic cough readout? - Management confirmed that key secondary endpoints will include the EXACT-2 and CS-VAS metrics, but specifics on additional secondary endpoints were not provided [82] Question: Will the next RCC trial have any changes in inclusion criteria? - Management stated that the inclusion criteria will remain similar to the previous study, focusing on patients with a minimum level of cough [60]

Financial Data and Key Metrics Changes - For Q4 2024, the company reported a net loss of $11.4 million, compared to a net loss of $7.8 million in Q4 2023, indicating a deterioration in financial performance [17] - R&D expenses increased to $9.3 million in Q4 2024 from $6.5 million in Q4 2023, primarily due to higher clinical trial costs [17] - G&A expenses rose to $2.9 million in Q4 2024 from $2.4 million in Q4 2023, mainly due to increased stock-based compensation and personnel-related expenses [17] - As of December 31, 2024, cash, cash equivalents, and marketable securities totaled $107.6 million, bolstered by a $50 million offering completed in December [18] Business Line Data and Key Metrics Changes - The company achieved three positive data readouts in 2024, including studies related to chronic cough patients with IPF and refractory chronic cough [3][4] - The Human Abuse Potential Study showed statistically significant lower drug liking compared to butorphanol, supporting the drug's profile [6] - The Sample Size Re Estimation analysis confirmed the original sample size of 160 patients for the Phase 2b study in IPF chronic cough, allowing the company to stay on track for enrollment [8] Market Data and Key Metrics Changes - The RIVER trial in patients with refractory chronic cough showed a 57% placebo-adjusted change from baseline with a p-value of less than 0.0001, indicating strong efficacy [11] - The company is targeting a subsegment of the refractory chronic cough population, focusing on patients who have failed prior therapies, which represents a significant unmet need [12] Company Strategy and Development Direction - The company plans to develop HEDUVO in serious chronic cough conditions, positioning it as a first-in-class therapy in IPF and potentially best-in-class across chronic cough indications [15] - The next steps include preparing for an end-of-Phase 2 meeting with the FDA for the IPF program and developing a protocol for the next RCC study [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the execution of clinical trials and the positive data readouts, which are expected to drive future growth [3][4] - The company anticipates cash burn of approximately $12 million to $14 million per quarter in Q1 and Q2 of 2025, with guidance remaining unchanged for cash runway into the second half of 2026 [18][19] Other Important Information - The company plans to present more data at upcoming conferences, including the American Thoracic Society meeting in May and the European Respiratory Society Congress in September [14][15] - The company is actively planning for the next steps in the development of HEDUVO, with a focus on both IPF and RCC [12] Q&A Session Summary Question: Could you speak about the patients enrolled in the CORAL study? - Management confirmed that no changes were made to the study protocol or sites after the sample size estimation, maintaining consistency in the patient population [22][23] Question: Can you comment on the discontinuation rate in the CORAL study? - The discontinuation rate remained in single digits throughout the study, indicating stability in patient retention [24] Question: What are the placebo response expectations for the IPF chronic cough Phase 2 study? - Management indicated that the placebo effect has been well-behaved in prior studies, with conservative assumptions around the expected effect size [29] Question: How will the RCC patient population be split between P2X3 and HEDUVO? - The company plans to target treatment failure patients, suggesting that HEDUVO will be considered after P2X3 therapy fails [33] Question: What secondary endpoints will matter most for driving HEDUVO prescriptions? - Management highlighted the importance of linking secondary endpoints to the primary endpoint of objective cough severity, with quality of life metrics also being considered [80]

Trevi Therapeutics Inc (TRVI) Q4 2024 Earnings Call March 18, 2025 04:30 PM ET Company Participants Jennifer Good - Co-Founder, CEO, President & DirectorLisa Delfini - Chief Financial OfficerMayank Mamtani - Senior Managing DirectorAnnabel Samimy - Managing DirectorRyan Deschner - Vice President - Equity ResearchBrandon Folkes - Managing Director - Equity Research Conference Call Participants None - AnalystLeland Gershell - MD & Senior Biotechnology AnalystSerge Belanger - Senior Analyst Operator Good after ...

Part I [Business](index=8&type=section&id=Item%201.%20Business) Trevi Therapeutics is a clinical-stage biopharmaceutical company developing Haduvio for chronic cough in IPF, non-IPF ILD, and RCC - The company is a clinical-stage biopharmaceutical firm whose primary focus is the development and commercialization of its sole investigational therapy, **Haduvio (oral nalbuphine ER)**[21](index=21&type=chunk) - Haduvio's target indications are chronic cough in patients with idiopathic pulmonary fibrosis (IPF), chronic cough in patients with non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC)[21](index=21&type=chunk) - Haduvio is an oral extended-release formulation of nalbuphine, functioning as a **kappa-opioid receptor agonist and a mu-opioid receptor antagonist (KAMA)**, and is not a controlled substance in the U.S. and most of Europe[22](index=22&type=chunk) - The company has paused further development of Haduvio for prurigo nodularis to focus its strategy on chronic cough indications[73](index=73&type=chunk) - Trevi has retained worldwide commercial rights for Haduvio and plans to build its own specialty sales force in the U.S., while seeking partners for commercialization outside the U.S.[36](index=36&type=chunk)[99](index=99&type=chunk) [Haduvio Development Programs](index=11&type=section&id=Haduvio%20Development%20Programs) Haduvio development programs focus on chronic cough, with IPF Phase 2b CORAL results expected Q2 2025 and positive RCC Phase 2a RIVER data - Chronic Cough in IPF Program: Enrollment for the Phase 2b CORAL trial was completed in February 2025, with topline results expected in **Q2 2025**. A Phase 3 program is anticipated to start in the **first half of 2026**[26](index=26&type=chunk)[28](index=28&type=chunk) - Refractory Chronic Cough (RCC) Program: The Phase 2a RIVER trial met its primary endpoint, demonstrating a statistically significant **67% reduction** in 24-hour cough frequency from baseline and a **57% placebo-adjusted reduction (p<0.0001)**[33](index=33&type=chunk) - Chronic Cough in non-IPF ILD Program: The company plans to conduct a Phase 2 clinical trial, contingent on positive data from the Phase 2b CORAL trial and discussions with health authorities[31](index=31&type=chunk)[59](index=59&type=chunk) - Human Abuse Potential (HAP) Study: Positive topline results announced in December 2024 showed a statistically significant lower "Drug Liking" for clinical doses of oral nalbuphine compared to 6mg IV butorphanol[35](index=35&type=chunk)[74](index=74&type=chunk) [Competition](index=18&type=section&id=Competition) Trevi Therapeutics faces competition in chronic cough from companies developing treatments for IPF and RCC, alongside off-label therapeutics - For chronic cough in IPF, Haduvio may compete with product candidates from Nerre Therapeutics (orvepitant), Melius Pharma (ME-015), Boehringer Ingelheim (BI 1839100), and Seyltx, Inc. (ifenprodil)[82](index=82&type=chunk) - For RCC, Haduvio faces competition from GSK's camlipixant (a P2X3 antagonist), with other candidates in development by Nocion Therapeutics, Axalbion Therapeutics, Addex Therapeutics, and Seyltx, Inc.[83](index=83&type=chunk)[84](index=84&type=chunk) - The company also anticipates competition from therapeutics not specifically approved for chronic cough, such as benzonatate, opioids, corticosteroids, and neuromodulators[85](index=85&type=chunk) [Intellectual Property and Licensing](index=20&type=section&id=Intellectual%20Property%20and%20Licensing) The company's IP strategy relies on owned and licensed patents, holding an exclusive worldwide license from Endo Pharmaceuticals for Haduvio formulations, but lacks composition of matter patents - The company has an exclusive, worldwide license from Endo Pharmaceuticals to develop and commercialize products incorporating nalbuphine hydrochloride, including Haduvio, with potential milestone payments of up to **$1.1 million** and royalties on net sales[89](index=89&type=chunk)[90](index=90&type=chunk) - As of December 31, 2024, the company owned five U.S. patents and 19 foreign patents, with expiration dates between **2032 and 2039**, and a new U.S. patent for Haduvio's use in IPF patients with hepatic impairment is expected to expire in **2042**[101](index=101&type=chunk) - The intellectual property in-licensed from Endo includes six U.S. patents and four foreign patents related to Haduvio's formulation, expiring between **2026 and 2029**[102](index=102&type=chunk) - The company does not own or exclusively license any composition of matter patents for Haduvio[103](index=103&type=chunk) [Government Regulation](index=22&type=section&id=Government%20Regulation) The company's operations are subject to extensive U.S. and international regulations, requiring multi-phase clinical trials, NDA submission, and post-approval compliance with manufacturing, marketing, and safety reporting - The drug approval process in the U.S. requires completing preclinical studies, filing an IND, and conducting Phase 1, 2, and 3 clinical trials to establish safety and efficacy before submitting an NDA to the FDA[109](index=109&type=chunk)[122](index=122&type=chunk)[123](index=123&type=chunk)[124](index=124&type=chunk) - In the E.U., the new Clinical Trials Regulation (CTR) streamlines the application process for multi-state trials through a single submission via the Clinical Trials Information System[212](index=212&type=chunk) - The U.S. Food and Drug Omnibus Reform Act (FDORA) now requires sponsors to submit a Diversity Action Plan (DAP) for all Phase 3 or pivotal studies to encourage enrollment of diverse patient populations[126](index=126&type=chunk) - Post-approval, the company will be subject to ongoing regulatory requirements, including cGMP for manufacturing, pharmacovigilance, and strict rules on advertising and promotion, with prohibitions on off-label marketing[159](index=159&type=chunk)[163](index=163&type=chunk) [Risk Factors](index=50&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks, including significant financial losses, need for additional capital, dependence on a single product, potential clinical trial failures, competition, reliance on third-party manufacturers, and IP challenges - The company has a history of significant losses, with a net loss of **$47.9 million** in 2024 and an accumulated deficit of **$287.0 million** as of December 31, 2024, expecting to continue incurring losses[246](index=246&type=chunk) - The company will need substantial additional funding, as existing cash, cash equivalents, and marketable securities of **$107.6 million** are expected to fund operations only into the **second half of 2026**[252](index=252&type=chunk)[255](index=255&type=chunk) - The business is entirely dependent on the successful development and commercialization of its sole product candidate, Haduvio; failure or significant delays would substantially harm the company[261](index=261&type=chunk) - The company relies on third parties for manufacturing, including a single supplier (Mallinckrodt) for the active ingredient in Haduvio, posing a significant supply chain risk[329](index=329&type=chunk)[332](index=332&type=chunk) - Haduvio, if approved, will likely carry an opioid class label warning for respiratory depression and faces the risk of being classified as a controlled substance by the DEA, which could restrict its commercial potential[290](index=290&type=chunk)[292](index=292&type=chunk) - The significant number of outstanding warrants could negatively affect the stock price, make future equity financing more difficult, and could entitle warrant holders to a disproportionate share of consideration in a sale of the company[494](index=494&type=chunk)[497](index=497&type=chunk) [Cybersecurity](index=111&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risks through a comprehensive program overseen by the audit committee and a dedicated Cybersecurity Committee, with no material threats currently identified - The audit committee of the board of directors provides direct oversight over cybersecurity risk[521](index=521&type=chunk) - A Cybersecurity Committee, led by a part-time CIO and including the CEO and CFO, meets quarterly to manage cybersecurity risks[522](index=522&type=chunk) - The board of directors has concluded that there are currently no known cybersecurity threats reasonably likely to materially affect the company's business, operations, or financial condition[520](index=520&type=chunk) [Properties](index=111&type=section&id=Item%202.%20Properties) The company's headquarters is located in New Haven, Connecticut, where it leases approximately 12,500 square feet of office space under a lease expiring in February 2028 - The company leases approximately **12,500 square feet** of office space in New Haven, Connecticut for its headquarters[524](index=524&type=chunk) - The current lease expires in **February 2028**, with an option to extend for an additional five years[524](index=524&type=chunk) [Legal Proceedings](index=111&type=section&id=Item%203.%20Legal%20Proceedings) As of the filing date, Trevi Therapeutics, Inc. is not subject to any material legal proceedings - The company is not currently a party to any material legal proceedings[526](index=526&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=113&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Trevi Therapeutics' common stock trades on Nasdaq under "TRVI"; the company has never paid cash dividends and plans to retain earnings for growth - The company's common stock is listed on the Nasdaq Stock Market under the ticker symbol **"TRVI"**[529](index=529&type=chunk) - The company has never declared or paid cash dividends and does not plan to in the foreseeable future, intending to retain all future earnings for business operations and development[530](index=530&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=113&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For 2024, Trevi Therapeutics reported a net loss of **$47.9 million**, up from **$29.1 million** in 2023, driven by increased R&D and G&A expenses, with **$107.6 million** in cash expected to fund operations into H2 2026 Financial Performance Summary (in thousands) | | Year Ended December 31, | | | | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **Change** | | **Research and development** | $39,377 | $23,683 | $15,694 | | **General and administrative** | $12,147 | $10,240 | $1,907 | | **Total operating expenses** | $51,524 | $33,923 | $17,601 | | **Loss from operations** | ($51,524) | ($33,923) | ($17,601) | | **Total other income, net** | $3,583 | $4,826 | ($1,243) | | **Net loss** | **($47,911)** | **($29,065)** | **($18,846)** | - Research and development expenses increased by **$15.7 million (66.3%)** in 2024, primarily due to increased clinical development costs for the Phase 2b CORAL trial, Phase 2a RIVER trial, HAP study, and Phase 1b TIDAL study[560](index=560&type=chunk) - General and administrative expenses increased by **$1.9 million (18.6%)** in 2024, mainly due to higher personnel-related costs, stock-based compensation, IT services, and market research[561](index=561&type=chunk) - As of December 31, 2024, the company had **$107.6 million** in cash, cash equivalents, and marketable securities, which management believes are sufficient to support operations into the **second half of 2026**[546](index=546&type=chunk)[578](index=578&type=chunk) Cash Flow Summary (in thousands) | | Twelve Months Ended December 31, | | | | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **Change** | | **Net cash used in operating activities** | ($38,256) | ($31,710) | ($6,546) | | **Net cash (used in) provided by investing activities** | ($21,528) | $59,428 | ($80,956) | | **Net cash provided by (used in) financing activities** | $61,484 | ($7,910) | $69,394 | [Controls and Procedures](index=124&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2024, management concluded that the company's disclosure controls and internal control over financial reporting were effective at a reasonable assurance level - Management concluded that the company's disclosure controls and procedures were effective as of **December 31, 2024**[592](index=592&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of **December 31, 2024**, based on the 2013 COSO framework[594](index=594&type=chunk) - No changes in internal control over financial reporting occurred during the fourth quarter of 2024 that materially affected, or are reasonably likely to materially affect, these controls[596](index=596&type=chunk) Part III Information for Part III, including details on directors, executive officers, corporate governance, executive compensation, security ownership, and certain relationships and transactions, is incorporated by reference from the company's 2025 Annual Meeting of Stockholders Proxy Statement [Directors, Executive Officers, Corporate Governance, Compensation, and Related Matters](index=125&type=section&id=Items%2010-14) - Information for Items 10, 11, 12, 13, and 14 is incorporated by reference from the registrant's 2025 Annual Meeting of Stockholders Proxy Statement[600](index=600&type=chunk)[601](index=601&type=chunk)[602](index=602&type=chunk)[603](index=603&type=chunk)[604](index=604&type=chunk) Part IV [Exhibits, Financial Statement Schedules](index=127&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section contains the company's Consolidated Financial Statements for 2024 and 2023, and a list of all exhibits filed with the Form 10-K, with all financial statement schedules omitted as not applicable or included elsewhere - This section includes the Consolidated Financial Statements and a list of exhibits filed as part of the Annual Report[606](index=606&type=chunk)[608](index=608&type=chunk) - All financial statement schedules have been omitted because they are not applicable or the required information is already present in the financial statements or accompanying notes[607](index=607&type=chunk) Financial Statements [Consolidated Balance Sheets](index=136&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, Trevi Therapeutics had total assets of **$110.9 million**, up from **$89.4 million** in 2023, driven by increased cash and marketable securities, with total liabilities rising to **$11.3 million** and equity to **$99.6 million** Consolidated Balance Sheets (in thousands) | (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Current Assets** | **$109,428** | **$87,547** | | Cash and cash equivalents | $34,097 | $32,397 | | Marketable securities | $73,525 | $50,574 | | **Total Assets** | **$110,900** | **$89,403** | | **Total Current Liabilities** | **$10,509** | **$5,824** | | Accounts payable | $3,414 | $1,809 | | Accrued expenses | $6,810 | $3,709 | | **Total Liabilities** | **$11,256** | **$6,856** | | **Total Stockholders' Equity** | **$99,644** | **$82,547** | [Consolidated Statements of Comprehensive Loss](index=137&type=section&id=Consolidated%20Statements%20of%20Comprehensive%20Loss) For 2024, the company reported a net loss of **$47.9 million**, or **($0.47)** per share, compared to a net loss of **$29.1 million**, or **($0.29)** per share, in 2023, primarily due to increased R&D expenses Consolidated Statements of Comprehensive Loss (in thousands, except per share data) | (in thousands, except per share data) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $39,377 | $23,683 | | General and administrative | $12,147 | $10,240 | | **Loss from operations** | **($51,524)** | **($33,923)** | | **Net loss** | **($47,911)** | **($29,065)** | | **Basic and diluted net loss per common share** | **($0.47)** | **($0.29)** | | Weighted average common shares outstanding | 101,971,873 | 99,033,373 | [Consolidated Statements of Cash Flows](index=139&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For 2024, net cash used in operating activities was **$38.3 million**, used in investing activities was **$21.5 million**, and provided by financing activities was **$61.5 million**, resulting in a net increase in cash of **$1.7 million** Consolidated Statements of Cash Flows (in thousands) | (in thousands) | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | **Net cash used in operating activities** | **($38,256)** | **($31,710)** | | **Net cash (used in) provided by investing activities** | **($21,528)** | **$59,428** | | **Net cash provided by (used in) financing activities** | **$61,484** | **($7,910)** | | Net increase in cash and cash equivalents | $1,700 | $19,808 | | Cash and cash equivalents at end of period | $34,097 | $32,397 |

Financial Position - As of December 31, 2024, Trevi Therapeutics estimates its cash, cash equivalents, and marketable securities to be $107.6 million[4]. - The company emphasizes that the cash estimate is preliminary and subject to change, pending audit and review[5]. - The company has not yet filed audited financial results for the preliminary cash estimate[5]. - The report indicates that the company is not an emerging growth company under the relevant regulations[3]. Clinical Trials - The Phase 2a RIVER trial for refractory chronic cough has completed patient visits, with topline results expected in Q1 2025[7]. - The Phase 2b CORAL trial in idiopathic pulmonary fibrosis is approximately 80% enrolled, with topline results anticipated in the first half of 2025[8]. - The original sample size for the CORAL trial remains reaffirmed at 160 patients following a positive outcome from a sample size re-estimation analysis[8]. - Forward-looking statements include expectations for clinical trials and cash runway, highlighting inherent risks and uncertainties[9]. Events and Communications - The company is participating in the 14th Annual LifeSci Partners Corporate Access Event from January 13 to 15, 2025[4]. - The press release detailing these updates was issued on January 8, 2025[10].

Announced positive topline data from the Phase 2a RIVER trial in patients with refractory chronic cough (RCC), making Haduvio the first therapy in clinical development to show benefit in patients with chronic cough in idiopathic pulmonary fibrosis (IPF) and RCCCompleted enrollment in the Phase 2b CORAL trial in IPF patients with chronic cough in February 2025, with topline data expected in the second quarter of 2025Announced positive outcome from sample size re-estimation in the Phase 2b CORAL trial, result ...

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]