Contradictions Unveiled: Trevi Therapeutics' Q4 2024 Earnings Call Reveals Key Challenges in CORAL Study and Treatment Strategy

These are the key contradictions discussed in Trevi Therapeutics' latest 2024Q4 earnings call, specifically including: Sample Size Re-estimation (SSRE) in the CORAL Study, Patient Population and Treatment Strategy, Dose Optimization, and Placebo Response Expectation in IPF Studies:



Clinical Data and Trial Success:
- Trevi Therapeutics reported positive results from its Human Abuse Potential (HAP) study, with reduced drug liking compared to butorphanol for both 162 mg and 81 mg nalbuphine doses.
- The company successfully completed enrollment and expects data from the Phase 2b CORAL trial in IPF chronic cough patients by Q2 2025.
- The RIVER trial in refractory chronic cough (RCC) met its primary endpoint, demonstrating a significant reduction in 24-hour objective cough frequency.
- These successes are attributed to the high quality of the trials, effective trial designs, and the unique mechanism of action of Haduvio.

Financial Performance:
- Trevi reported a net loss of $11.4 million for Q4 2024, compared to $7.8 million in the same period last year.
- R&D expenses increased to $9.3 million in Q4 2024, driven by higher clinical trial costs and personnel-related expenses.
- The company's cash position grew to $107.6 million, including a $50 million offering completed post positive data readouts.
- The increase in R&D expenses is primarily due to expanded clinical trials, while the cash position reflects successful fundraising efforts.

Market Strategy and Product Positioning:
- Trevi plans to develop Haduvio as a treatment for treatment failure RCC patients following off-label therapies.
- The company intends to focus on patients who have exhausted available treatment options, representing a high unmet need.
- They anticipate that RCC patients would try P2X3 antagonists first, followed by Haduvio if the P2X3 antagonist proves ineffective.
- This strategy capitalizes on the high unmet need in the RCC market and leverages the company's unique mechanism of action to address the limitations of existing treatments.