Release Date: August 08, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Trevi Therapeutics Inc (TRVI, Financial) is making significant progress in its clinical trials for chronic cough and idiopathic pulmonary fibrosis (IPF), with several data readouts expected by year-end.
- The company has bolstered its team by hiring Dr. Meg Garin, who has experience in progressing clinical development, to oversee the RIVER trial.
- The Phase 2a RIVER trial in refractory chronic cough (RCC) is progressing well, with approximately 80% of subjects enrolled and data expected in the fourth quarter of this year.
- Trevi Therapeutics Inc (TRVI) has a strong cash position with $69.5 million in cash, cash equivalents, and marketable securities, providing a runway into 2026.
- The company is conducting supportive studies, including a human abuse potential study and a respiratory physiology study, to inform the development path forward for Haduvio in chronic cough conditions.
Negative Points
- Trevi Therapeutics Inc (TRVI) reported a net loss of $12.4 million for the second quarter of 2024, an increase from a net loss of $7.1 million in the same quarter of 2023.
- Research and development expenses increased significantly to $10 million during the second quarter of 2024, compared to $5.8 million in the same quarter of 2023.
- There is an imbalance in the enrollment of subjects between the two stratification arms in the RIVER trial, which may require keeping the study open longer to balance the arms.
- The company faces challenges in maintaining premium pricing for Haduvio in RCC while optimizing its value without cannibalizing the IPF market.
- The potential for regulatory challenges exists, particularly concerning the human abuse potential study and the scheduling of nalbuphine ER.
Q & A Highlights
Q: When designing the RIVER trial for chronic cough, did you use different powering assumptions for the different severity groups?
A: (David Clark, Chief Medical Officer) The primary endpoint in RIVER is the total population N of 60, and the same assumptions for effect size were made for the subgroup analyses.
Q: Can you confirm the scheduling status of nalbuphine and any expectations for a dose response in the human abuse potential study?
A: (Jennifer Good, President, CEO) Nalbuphine is unscheduled by the DEA and has been for decades. We expect it to remain unscheduled based on existing data. The human abuse potential study is a formality to meet current standards.
Q: Could you comment on the enrollment expectations for the respiratory physiology study and the doses being evaluated?
A: (David Clark, Chief Medical Officer) The study uses the same doses as RIVER and CORAL, up to 108 mg BID. We start with the same IPF population as CORAL and may expand to include sleep-disordered breathing subtypes.
Q: How does the potential outcome of the RCC trial impact your plans for IPF?
A: (Jennifer Good, President, CEO) IPF remains our lead indication due to its severe unmet need. We may position Haduvio as a third-line therapy in RCC to maintain premium pricing, but this will depend on the data.
Q: What are the differences between the Phase 2a RIVER and CANAL trials?
A: (David Clark, Chief Medical Officer) The RIVER trial capped the dose at 108 mg BID and increased the washout period to three weeks. Unlike CANAL, RIVER collects weekly objective cough data.
Q: What are your expectations for the human abuse potential (HAP) study outcome?
A: (Jennifer Good, President, CEO) A positive outcome would show no dose-dependent likability. We expect nalbuphine to be less likable than comparators, which should strengthen our position with the FDA.
Q: Can you provide an overview of the current patent coverage for nalbuphine and its applicability to IPF and RCC?
A: (Jennifer Good, President, CEO) We have method of treatment patents issued through 2039 for IPF cough, with additional applications that could extend protection to 2041 or 2043. RCC falls under the same umbrella, and we will file claims based on RIVER study data.
Q: How large is the treatable patient population for RCC in the US?
A: (Jennifer Good, President, CEO) We estimate about 2 to 3 million treatable patients in the US, out of roughly 7 million diagnosed, who are seeking treatment and not receiving proper care.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
