Trevi Therapeutics Q3 2024 Financial Results and Business Updates

Trevi Therapeutics, Inc., a biopharmaceutical company focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), has announced its financial results for the third quarter of 2024, along with business updates. The company completed the enrollment for the Phase 2a RIVER trial aimed at treating RCC in October 2024, with the topline results expected in the first quarter of 2025. Furthermore, Trevi has reached the halfway mark in patient enrollment for the Phase 2b CORAL trial focusing on chronic cough in IPF patients, expecting sample size re-estimation outcomes in December 2024.

Jennifer Good, the President and CEO of Trevi Therapeutics, expressed optimism about the progress made in their clinical programs. She highlighted the potential of Haduvio’s mechanism to address the unmet needs and market opportunities in both chronic cough conditions. Haduvio operates on the cough reflex arc both centrally and peripherally as a kappa agonist and mu antagonist, which are opioid receptors crucial for managing cough hypersensitivity.

During the third quarter, Trevi also completed dosing in the Human Abuse Potential (HAP) study, with results anticipated in December 2024. The company announced the appointment of James V. Cassella, Ph.D., as Chief Development Officer, adding to their executive team.

Financially, Trevi ended the third quarter with $65.5 million in cash, cash equivalents, and marketable securities, providing an expected cash runway into the second half of 2026. The company reported an increase in research and development expenses to $11.2 million, compared to $6.3 million during the same period in 2023. This rise was mainly attributed to higher clinical development costs for the ongoing trials and personnel-related expenses. General and administrative expenses also witnessed a slight increase to $2.9 million from $2.7 million in the previous year, primarily due to stock-based compensation expenses. Consequently, Trevi reported a net loss of $13.2 million for the third quarter, up from $7.7 million in the same period in 2023.

The company plans to participate in upcoming events such as the Stifel 2024 Healthcare Conference in November and the Piper Sandler 36th Annual Healthcare Conference in December.

Trevi Therapeutics is actively developing Haduvio for chronic cough in IPF and RCC. Chronic cough is notably prevalent among the approximately 140,000 IPF patients in the U.S., with up to 85% experiencing this condition. Chronic cough can significantly impact patients, leading to disease progression, increased risk of mortality, or necessitating lung transplants. It also diminishes the patients’ quality of life socially, physically, and psychologically. Currently, there are no approved treatments for chronic cough in IPF in the U.S., with existing options providing minimal relief.

Refractory chronic cough affects about 2-3 million adults in the U.S., caused by cough reflex hypersensitivity in both central and peripheral nerves. It is highly disruptive and can lead to complications such as urinary incontinence in females, sleep disruption, and social embarrassment, imposing significant social and economic burdens. Haduvio is being developed to treat moderate to severe RCC, and there are no approved therapies for RCC in the U.S. as well.

Trevi is proposing Haduvio as the trade name for oral nalbuphine ER, though its safety and efficacy have not yet been evaluated by any regulatory authority. The company continues to focus on advancing its clinical trials and achieving milestones that could lead to significant breakthroughs in treating chronic cough conditions.