Trevi Therapeutics Provides Strategic Updates Ahead of Annual LifeSci Partners Corporate Access Event Held During the J.P. Morgan Healthcare Conference
MWN-AI** Summary
Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, recently provided key updates regarding its investigational therapy Haduvio™ (oral nalbuphine ER) during the 15th Annual LifeSci Partners Corporate Access Event, coinciding with the J.P. Morgan Healthcare Conference in San Francisco.
The company announced an End-of-Phase 2 meeting with the FDA scheduled for the first quarter of 2026. This meeting will focus on the clinical development pathway for Haduvio in treating chronic cough associated with idiopathic pulmonary fibrosis (IPF). Following this meeting, Trevi plans to initiate its Phase 3 clinical program targeting this patient demographic in the first half of 2026.
Additionally, Trevi is gearing up to launch a Phase 2b trial aimed at addressing refractory chronic cough (RCC), also planned for the first half of 2026. Jennifer Good, President and CEO of Trevi, expressed enthusiasm about the company’s plans for 2026, highlighting a commitment to advancing Haduvio for patients suffering from debilitating chronic cough conditions.
Chronic cough in patients with IPF and non-IPF interstitial lung disease presents a significant unmet medical need, with FDA-approved therapies currently unavailable. Approximately 150,000 U.S. patients suffer from IPF, of which two-thirds experience uncontrolled chronic cough. Similarly, around 2-3 million Americans are affected by RCC, further illustrating the necessity for effective treatments.
Haduvio aims to provide relief by acting on the cough reflex through both central and peripheral opioid receptors. Trevi Therapeutics is focused on advancing Haduvio's development to alleviate the burdens associated with chronic cough, enhancing the quality of life for patients afflicted by these conditions. The company's updates set an optimistic tone for upcoming clinical milestones.
MWN-AI** Analysis
Trevi Therapeutics, Inc. (TRVI) is positioning itself for potential growth as it accelerates the clinical development of its investigational therapy Haduvio™ for chronic cough in patients suffering from idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). Given that the company has announced a forthcoming End-of-Phase 2 meeting with the FDA and plans for a Phase 2b trial in RCC, investors should monitor these developments closely as they could shape the company’s future trajectory.
The unmet medical need in treating chronic cough related to IPF and RCC is substantial, with millions of patients lacking FDA-approved therapies. Notably, Haduvio is unique in demonstrating significant reductions in cough frequency in clinical trials, which positions it as a potentially pivotal treatment option in a market ripe for innovation. The upcoming discussions with the FDA will be crucial, as clarity on the regulatory pathway can significantly impact investor confidence and stock performance.
Investors should consider the timing of Trevi's clinical initiatives, particularly as they coincide with major healthcare events, such as the J.P. Morgan Healthcare Conference. This timing offers heightened visibility and potential for strategic partnerships that could enhance financial backing for ongoing trials. Additionally, the incoming Phase 2b trial in RCC represents a key milestone that could diversify and strengthen Trevi's pipeline.
However, potential investors should remain aware of inherent risks, including the uncertainty surrounding clinical trial results and regulatory acceptance. Trevi’s capacity to fund its operations and trial commitments will also be critical factors to watch. With a strategic focus on execution in 2026, Trevi could evolve into a significant player within its niche, making it an interesting option for investors looking for exposure to the biopharmaceutical sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
FDA End-of-Phase 2 meeting scheduled to take place in the first quarter of 2026 for the chronic cough program in patients with idiopathic pulmonary fibrosis
Phase 2b refractory chronic cough trial planned to initiate in the first half of 2026
NEW HAVEN, Conn., Jan. 8, 2026 /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), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced strategic updates ahead of its participation in the 15th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, CA, from January 12-14, 2026. This event will be held during the week of the annual J.P. Morgan Healthcare Conference.
"We are excited as we begin 2026 to continue the clinical development of Haduvio in our key chronic cough indications," said Jennifer Good, President and CEO of Trevi Therapeutics. "We have an End-of-Phase 2 meeting scheduled with the FDA, and we hope to align on our development program for the treatment of chronic cough in patients with IPF and then initiate that program. We have also been preparing to initiate a Phase 2b trial in RCC in the first half of this year. We expect that 2026 will be a year of focused execution at Trevi as we work to advance Haduvio a step closer to patients suffering from these debilitating chronic cough conditions."
Key Company Highlights
- Chronic Cough in IPF
- The Company was granted an End-of-Phase 2 meeting by the FDA, scheduled to take place in the first quarter of 2026. This meeting will discuss the clinical development and regulatory pathway for the New Drug Application of nalbuphine ER for the treatment of chronic cough in patients with IPF. Following this meeting, the Company expects to initiate its Phase 3 program of nalbuphine ER in this patient population in the first half of 2026.
- Refractory Chronic Cough
- The Company plans to initiate a Phase 2b trial in patients with RCC in the first half of 2026.
- David Hastings, the new Chief Financial Officer for Trevi Therapeutics, will attend the LifeSci Partners Corporate Access Event along with other members of the senior management team.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.
Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.
RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8?weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, expectations regarding Trevi's sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials; as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Investor Contact?
Jonathan Carlson?
Trevi Therapeutics, Inc.?
(203) 654 3286?
carlsonj@trevitherapeutics.com?
Media Contact?
Rosalia Scampoli?
914-815-1465?
rscampoli@marketcompr.com
SOURCE Trevi Therapeutics, Inc.
FAQ**
What specific outcomes does Trevi Therapeutics Inc. (TRVI) hope to achieve during the upcoming End-of-Phase 2 meeting with the FDA regarding the chronic cough program for IPF patients?
How does Trevi Therapeutics Inc. (TRVI) plan to address the significant unmet need for FDA-approved therapies in chronic cough associated with idiopathic pulmonary fibrosis and non-IPF ILD?
What are the key milestones Trevi Therapeutics Inc. (TRVI) aims to achieve in 2026, particularly concerning the initiation of the Phase 2b trial for refractory chronic cough?
Can Trevi Therapeutics Inc. (TRVI) elaborate on the potential market size and implications for Haduvio™ if it gains FDA approval for chronic cough treatment in IPF and RCC populations?
**MWN-AI FAQ is based on asking OpenAI questions about Trevi Therapeutics Inc. (NASDAQ: TRVI).
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