Release Date: March 13, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you explain the impact of measuring the absolute change in steroid reduction from baseline to week 48 versus the previous method of average cumulative steroid dose? A: Sanjay Shukla, President and CEO, explained that the change simplifies the analysis by focusing on the starting and ending doses, potentially maximizing the steroid delta observed. The trial remains over 90% powered to show a statistically significant steroid reduction compared to placebo.
Q: What is the level of interest in the Expanded Access Program (EAP) among trial participants? A: Sanjay Shukla noted robust interest in the EAP, although participation is limited by local regulatory requirements in some countries. The company remains blinded to treatment assignments, but the interest suggests positive interim signals.
Q: Why was the statistical analysis plan for steroid reduction changed, and what should we look for in the baseline demographics at the ATS conference? A: Sanjay Shukla stated that the change was based on FDA feedback for a more simplified assessment. At the ATS conference, investors should focus on the average prednisone dose and background immunomodulator use to understand the patient profile.
Q: How does the trial design account for patients mid-taper at week 48, and what does this mean for the primary endpoint measurement? A: Sanjay Shukla explained that the trial design includes a trailing average of 28 days to account for patients mid-taper, ensuring a more accurate measure of the change from baseline.
Q: What are the expectations for the interim data from the scleroderma ILD study, and how might it guide future directions? A: Sanjay Shukla highlighted the focus on skin pathology as a high bar for improvement. Positive results could open opportunities for Esofiamide in other systemic diseases, potentially expanding its application beyond lung conditions.
Q: Can you discuss the potential for steroid reduction without therapeutic intervention in the EAP? A: Sanjay Shukla mentioned that the EAP could reveal whether long-term treatment induces remission beyond managing active inflammation, providing insights into the drug's durability and market potential.
Q: What is the current manufacturing readiness for potential early commercialization? A: Sanjay Shukla confirmed that significant investments have been made to ensure commercial readiness, transitioning from clinical to commercial-grade partners to meet potential demand upon successful trial outcomes.
Q: How does the company plan to use data from the EAP in the BLA submission, and will there be significant data available before submission? A: Sanjay Shukla stated that while the EAP data is not part of the trial database, it could provide valuable insights if investigators choose to publish findings. The company aims to maintain BLA timelines without delay.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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