Release Date: November 06, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Trevi Therapeutics Inc (TRVI, Financial) has made significant progress in its clinical development plans, particularly in chronic cough and idiopathic pulmonary fibrosis (IPF) trials.
- The company has a strong cash position with $65.5 million in cash equivalents and marketable securities, providing a cash runway into the second half of 2026.
- Trevi Therapeutics Inc (TRVI) has successfully completed enrollment in its RCC trial and is on track with its IPF cough trial, with key data readouts expected in the near future.
- The addition of James Cassella as Chief Development Officer brings extensive experience in CNS drug development, which is expected to be invaluable for late-stage development and regulatory approval processes.
- The company is conducting a human abuse potential study to align with FDA guidance, which could support an unscheduled designation for nalbuphine if approved for chronic cough.
Negative Points
- Trevi Therapeutics Inc (TRVI) reported a net loss of $13.2 million for the third quarter of 2024, an increase from the $7.7 million loss in the same quarter of 2023.
- Research and development expenses have significantly increased, reflecting the high costs associated with ongoing clinical trials.
- The company faces challenges in the competitive landscape, with continued failures of competitor products in disease modification trials for IPF and RCC.
- There is uncertainty regarding the outcome of the human abuse potential study and its impact on the drug's scheduling status.
- The sample size re-estimation in the IPF cough trial could lead to an increase in the number of patients required, potentially delaying results and increasing costs.
Q & A Highlights
Q: Can you clarify your expectations for Butorphanol drug liking in the half study and what evidence supports that? Also, what do you want to see from nalbuphine in the half study to support an unscheduled designation?
A: James Cassella, Chief Development Officer, explained that the study is designed to assess the relative abuse liability of nalbuphine compared to Butorphanol, which is known to be abused. The primary endpoint is the VAS drug liking scale. The study aims to show Butorphanol differentiates from placebo by at least 15 points and to determine if nalbuphine has a lower relative abuse potential. The absolute abuse potential of nalbuphine will also be assessed against placebo, with a preset margin of 11 points. The results will contribute to the overall package for FDA review.
Q: Regarding the SSRE in the IPF cough trial, would there be a fixed increase in sample size if needed, or would it be variable?
A: Jennifer Good, President and CEO, stated that the sample size could increase from the original 160 to a maximum of 400, based on the actual data and conditional probability determined by the SSRE. It is not a fixed increase but a sliding scale based on the findings.
Q: In the RCC trial, are the two arms of different degrees of coughers balanced?
A: James Cassella confirmed that while the trial aimed to stratify patients by cough count, the enrollment was cut off before complete balancing. This does not impact the overall analysis, which is based on the total number of participants, not subgroups. The data will still be sufficient for future statistical analysis and planning.
Q: What are the next steps after receiving the half trial results? Will it go directly to the FDA or be part of a larger meeting?
A: Jennifer Good indicated that the results would be submitted to the FDA and discussed in the end-of-phase-two meeting for the IPF trial. The half study results will be part of the NDA process but do not gate future efficacy studies.
Q: What is the timeline for the DEA to make a decision on scheduling once the half results are in? Also, what dose level of Butorphanol is being used?
A: Jennifer Good explained that the DEA process typically occurs at the end of the NDA review, if at all. The Butorphanol dose is a 6 mg infusion over an hour, designed to mimic the inhaled version on the market, as agreed with the FDA.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
