Release Date: March 06, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Following your meeting with the FDA, are there any specific callouts that they've guided for in the phase 3 trial design? A: Janet Hammond, Chief Development Officer: The FDA is fully aligned with our approach of conducting two open-label phase 3 trials. They did not have any substantive comments regarding the trial's conduct, and the open-label design is agreed upon given the drug properties and population studied.
Q: What can we expect in terms of the scope of your phase 2 readout later this half? A: Arantxa Horga, Chief Medical Officer: We expect to present additional data this summer at the EASL conference in May, including details on safety and other protocol specifics.
Q: For the phase 3 program, do you have an estimated number of cirrhotic patients across the two trials? A: Janet Hammond, Chief Development Officer: We aim for just over 10% of the trial population to be cirrhotic patients. While the number of cirrhotic patients has declined globally, we have set targets rather than absolute numbers, allowing some flexibility.
Q: Is there an ability to adjust the number of cirrhotic patients if the trial shows lower or higher enrollment? A: Janet Hammond, Chief Development Officer: Yes, we have flexibility in our targets. We aim to enroll enough patients to justify including this population in our label, but there are no absolute requirements.
Q: Regarding the modeling on slide 16, if plotted with EUSA, would you expect those lines to be right-shifted for EUSA across the non-cirrhotic population? A: Jean-Pierre Sommadossi, CEO: The model was developed by Dr. Alan Pearson from Los Alamos, and similar approaches have been validated and published for other direct antiviral therapies for HCV.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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