Trevi Therapeutics Q1 2024 Financial Results and Business Updates

Trevi Therapeutics, Inc., a clinical-stage biopharmaceutical company based in New Haven, Connecticut, has reported its financial results for the first quarter of 2024 and provided updates on its ongoing clinical trials. The company is focused on developing Haduvio™ (oral nalbuphine ER) for treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).

Trevi reiterated its timeline for the Phase 2a RIVER trial, which targets RCC. This study, involving around 60 participants, has all its sites activated, and data is expected in the latter half of 2024. Similarly, the Phase 2b CORAL trial, aiming to treat chronic cough in IPF with about 160 participants, continues to enroll patients, with topline results expected in the first half of 2025. Additionally, the Human Abuse Potential (HAP) study is 75% enrolled, with data anticipated in the second half of 2024.

Jennifer Good, President and CEO of Trevi Therapeutics, expressed satisfaction with the current state of their clinical trials and emphasized the significance of the chronic cough market in both IPF and RCC, where there are currently no approved therapies in the U.S. Good highlighted the potential of Haduvio's central and peripheral mechanisms of action to offer a meaningful treatment option for patients.

Trevi has also received FDA clearance for an Investigational New Drug (IND) application, allowing them to proceed with a Phase 1b trial to evaluate respiratory physiology in IPF patients with varying disease severities. This trial is scheduled to start in the third quarter of 2024.

Financially, Trevi ended the first quarter of 2024 with $72.8 million in cash, cash equivalents, and marketable securities, indicating a cash runway extending into 2026. Research and Development (R&D) expenses rose to $8.8 million from $5.0 million in the same period in 2023, primarily due to costs associated with the Phase 2b CORAL trial, Phase 2a RIVER trial, and HAP trial. General and Administrative (G&A) expenses increased to $3.1 million from $2.6 million due to higher costs in IT, finance staffing, and professional fees. Other income was $1.0 million, down from $1.2 million in the previous year. Consequently, the net loss for the first quarter of 2024 was $10.9 million, compared to $6.4 million in the same period of 2023.

Trevi announced it would host a live conference call and webcast to discuss these updates. The company also plans to participate in several upcoming events, including the Citizens JMP Life Sciences Conference, ATS 2024 International Conference, and the 2024 BIO International Convention.

Trevi Therapeutics is primarily developing Haduvio for chronic cough in IPF and RCC. This investigational therapy is a dual κ-opioid receptor agonist and μ-opioid receptor antagonist, acting both centrally and peripherally to potentially provide a synergistic antitussive effect. Chronic cough in IPF can significantly impact patients' quality of life and may lead to disease progression or even death. Current treatment options offer minimal relief, and there is a substantial unmet need for effective therapies. RCC affects up to 10% of adults, and Haduvio could potentially help those suffering from moderate to severe chronic cough.

Haduvio's development continues under the premise that there are currently no approved therapies for either IPF-associated chronic cough or RCC in the U.S. The safety and efficacy of Haduvio have not yet been evaluated by regulatory authorities.