Trevi Therapeutics Q3 2025 Results: Haduvio Phase 3 Plans for IPF Chronic Cough (2025)

Breaking News: Trevi Therapeutics Unveils Exciting Updates!

A Breath of Hope for Chronic Cough Sufferers

Trevi Therapeutics, a leading biopharmaceutical company, has just released its third-quarter financial results for 2025, along with some groundbreaking business updates. The company is making significant strides in its mission to develop innovative treatments for chronic cough, a condition that severely impacts the quality of life for patients with idiopathic pulmonary fibrosis (IPF) and other respiratory diseases.

But here's where it gets controversial... Trevi's investigational therapy, Haduvio™ (oral nalbuphine ER), has shown promising results in clinical trials, offering a glimmer of hope for patients with no approved therapies available. With a clear path for growth, the company is now preparing to initiate a comprehensive Phase 3 program for chronic cough in IPF patients, scheduled for the first half of 2026.

And this is the part most people miss... Chronic cough is not just an annoying symptom; it can lead to a higher risk of morbidity and mortality. Patients with IPF and non-IPF interstitial lung disease (non-IPF ILD) often experience uncontrolled chronic cough, with some coughing up to 1,500 times a day! This relentless cough can worsen the disease, increase respiratory hospitalizations, and significantly impact patients' overall well-being.

Let's dive into the key updates:

Chronic Cough in IPF:
- Trevi is on track to request an End-of-Phase 2 meeting with the FDA in Q4 2025, followed by the initiation of its Phase 3 program in H1 2026.
- The safety review committee for the TIDAL study, assessing respiratory function and safety in IPF patients, has given the green light to complete enrollment, with no safety concerns identified.
- A successful Phase 1 drug-drug interaction study showed that Haduvio™ can be safely co-administered with standard antifibrotic therapies, opening up new treatment possibilities.
- Topline results from the Phase 2b CORAL trial were presented at the CHEST 2025 Annual Meeting, further supporting the potential of Haduvio™.

Refractory Chronic Cough (RCC):
- Building on the positive Phase 2a RIVER trial results, Trevi plans to initiate a Phase 2b RCC study in H1 2026.
- The RIVER trial results were presented at both the CHEST 2025 Annual Meeting and the ERS Congress 2025, gaining recognition in the scientific community.

Financial Highlights:
- Trevi ended Q3 2025 with a strong cash position of $194.9 million, providing a cash runway into 2028.
- Research and development expenses decreased in Q3 2025 compared to the same period in 2024, primarily due to the completion of certain clinical trials.
- General and administrative expenses increased slightly, mainly attributed to professional fees and personnel-related costs.
- Other Income, net, saw a significant increase, primarily due to higher interest income from invested cash and marketable securities.
- The net loss for Q3 2025 was $11.8 million, an improvement from the net loss of $13.2 million in Q3 2024.

Looking Ahead:
Trevi's management will host a conference call and webcast today at 4:30 p.m. EST to discuss these updates in more detail.

This is an exciting time for Trevi Therapeutics and the patients they aim to serve. With a robust financial position and promising clinical data, the company is well-positioned to make a significant impact on the lives of those suffering from chronic cough.

What are your thoughts on Trevi's progress? Do you think Haduvio™ has the potential to revolutionize the treatment landscape for chronic cough? Share your insights and let's spark a discussion!

Trevi Therapeutics Q3 2025 Results: Haduvio Phase 3 Plans for IPF Chronic Cough (2025)

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