Release Date: February 26, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What gives you confidence that you enrolled the correct proportion of patients for each score in the in front study to see a clear separation between litizinumab and placebo? Was there a cap for any of these patient populations? A: Saraswati Kenkare-Mitra, President and Head of Research and Development, explained that they intentionally targeted an early symptomatic population of FTD granulin with a distribution of 0.5 to 2 on the global score. They capped the CDR2s early in the trial to avoid enrolling too many patients who were further progressed and might not respond as well to treatment. They also collected data from a small cohort of at-risk participants for sensitivity analysis.
Q: Is there any read-through from the in front three study to AL 101, given the shared progranulin targeting? A: Saraswati Kenkare-Mitra stated that while both programs involve progranulin, they target different mechanisms. The in front three study focuses on normalizing progranulin levels in FTD granulin patients, while AL 101 aims to be protective against Alzheimer's disease. They believe the biomarkers and clinical outcomes used in the in front study will serve well in AL 101 trials.
Q: Can you highlight some key differences between your blood-brain barrier platform and others, such as Denali or Roche? A: Gary Romano, Chief Medical Officer, noted that Alector's ABC technology is versatile and tunable, allowing for optimization of efficacy and safety. It can be adapted for different types of therapeutic cargos, providing a flexible platform for various applications, including antibodies and proteins.
Q: How have you optimized the trial design for in front 3 to ensure the best chance of showing efficacy? A: Saraswati Kenkare-Mitra explained that they focused on enrolling symptomatic subjects and adjusted their primary analysis based on new data from observational studies. They also ensured a diverse geographic enrollment to capture a representative patient population.
Q: Can you compare and contrast your approach to FTD with other programs in clinical development? A: Saraswati Kenkare-Mitra highlighted that their approach with litizinumab involves normalizing progranulin levels, which has shown positive effects on biomarkers and disease progression in phase 2 studies. They believe their method of targeting the underlying pathophysiology offers a promising therapeutic option compared to other approaches.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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