Release Date: February 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: What supports your view that the 28-day dosing in the atopic dermatitis Phase Ib is enough time to show robust biomarker activity? How have you considered the inclusion/exclusion criteria for that Phase Ib? A: Jared Gollob, Chief Medical Officer, explained that prior dupilumab trials showed clear impacts on Th2 biomarkers and clinical endpoints like EASI and pruritus NRS within four weeks. The 28-day treatment should allow for a clear impact on Th2 biomarkers. The inclusion criteria ensure patients definitely have moderate to severe AD, minimizing placebo effects through rigorous site selection and monitoring.
Q: Why is the Phase 1b designed as a single-arm study without a placebo, especially given the placebo effects seen in other atopic dermatitis studies? A: Nello Mainolfi, CEO, stated that the study aims to demonstrate a robust biomarker profile comparable to dupilumab's four-week data. Biomarkers typically do not move substantially in placebo arms, and a placebo-controlled study would require a larger, longer trial. The focus is on moving quickly to Phase 2b.
Q: How do you plan to assess the bioavailability of KT-621 in tissues of interest, such as skin versus lung tissue? A: Nello Mainolfi, CEO, noted that preclinical data showed KT-621 is highly active at low oral doses and distributes evenly across tissues like blood, skin, spleen, and lungs. The expectation is that this profile will translate to humans, with blood and skin serving as surrogate tissues for measuring degradation.
Q: How will the Phase 1b study help shape the view of KT-621's profile potential, given its short duration and small size? A: Nello Mainolfi, CEO, emphasized that the Phase 1b study aims to demonstrate that STAT6 degradation has a dupilumab-like effect on biomarkers, which is crucial for convincing investigators and patients of the drug's potential. The study is designed to show that the drug is safe, well-tolerated, and effective in reducing biomarkers, setting the stage for Phase 2b studies.
Q: How do you plan to prioritize indications for KT-621 in the Phase 3 development program, given its broad potential? A: Nello Mainolfi, CEO, stated that the focus will be on a path to registration and breadth of opportunities. The initial Phase 3 campaigns will likely prioritize indications like asthma, AD, and potentially COPD, which are significant revenue drivers for similar drugs like dupilumab.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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