Release Date: February 05, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide more details on the feedback from the end of Phase 2 meeting, particularly regarding the potential size and comparator arms for the Phase 3 studies? A: Brian Lian, President and CEO, stated that the Phase 3 program will conform to guidance requiring at least 4,500 participants. There will be two studies: one in obese subjects and another in obese subjects with type 2 diabetes, targeting a 52-week treatment window. Further details on doses and other specifics will be provided upon trial initiation.
Q: Why was the timing for the start of the Phase 3 obesity study narrowed to the second quarter of 2025? A: Brian Lian explained that the adjustment was primarily logistical, related to the production of clinical materials. With better visibility on production timelines, they could focus the start window more precisely. Everything is proceeding according to plan.
Q: Are the Phase 3 studies going to be standard weight loss studies, and how long will it take to recruit patients? A: Brian Lian confirmed that the primary endpoint will be a change in body weight, with glycemic endpoints included in the diabetes study. The recruitment timeline cannot be provided yet as it depends on study initiation and enrollment queue.
Q: Will the monthly dosing for the subcutaneous formulation be included in the Phase 3 study and eventually in the label? A: Brian Lian mentioned that the long-term goal is to include monthly dosing in the label, though it's too early to determine if it will be in the initial NDA. The study will explore transitioning from weekly to monthly dosing to assess weight maintenance.
Q: For the Phase 2 oral VENTURE trial, why is the dose range broad, and is the highest dose realistic for pursuit? A: Brian Lian stated that the broad dose range is to evaluate if lower doses continue to show efficacy over a longer period. The highest dose tested in Phase 1 was well tolerated, and they are comfortable exploring slightly higher doses.
Q: What are the expectations for the 13-week weight loss in the VENTURE oral Phase 2 study, and can you comment on the cost of goods sold? A: Brian Lian indicated it's too early to predict 13-week weight loss outcomes. Regarding cost of goods sold, it's premature to discuss specifics, but they aim for a profitable product.
Q: Is there an update on the manufacturing agreement, and why is it taking time to finalize? A: Brian Lian noted that discussions are ongoing to enable the launch of a substantial commercial product. Progress is being made, and more information will be shared at the appropriate time.
Q: Regarding the amylin program, what needs to be completed for IND submission this year? A: Brian Lian stated that all IND-enabling work, particularly toxicology studies, needs to be completed to enable an IND filing this year.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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