Release Date: February 12, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: In the phase two target trial, what gives you confidence that the SBP reduction seen in the 12 patients can be extrapolated to phase 3? A: Jon Congleton, CEO: We looked at both in-office and 24-hour ambulatory measurements. Despite some subjects having baseline blood pressure below goal, the totality of evidence across different doses gave us confidence in the 50 mg QD dose for 24-hour blood pressure control.
Q: For the OSA trial, will improvement in the apnea hypopnea index be primarily due to fluid volume reduction, or would non-genomic effects contribute? A: David Rodman, CMO: The mechanism is primarily volume shifts, which cause fluid redistribution that obstructs the airway. Non-genomic effects like inflammation may also contribute, but the primary mechanism is volume-related.
Q: Given your guidance for Advance and Launch readout timelines, is there more refined guidance on when each will be presented? A: Jon Congleton, CEO: We continue to guide Advance-HTN for March and Launch-HTN for mid-first half of this year. Depending on when we get the top line results, we may do a corporate announcement in conjunction with the ACC meeting.
Q: What are your expectations around safety and tolerability for the upcoming pivotal readouts? A: Jon Congleton, CEO: Aldosterone synthase inhibitors reduce plasma aldosterone, affecting multiple pathways. We expect a more modest impact on potassium compared to MRAs, which often lead to hyperkalemia.
Q: Could you discuss the threshold for hyperkalemia rates in Advance and Launch, and how diuretics might impact these rates? A: Jon Congleton, CEO: A hyperkalemia rate of 5% or less is viewed favorably. Diuretics, which are potassium-wasting, could offset the modest rise in potassium seen with aldosterone synthase inhibitors.
Q: How do you expect the treatment effects observed with lorundrostat in the pivotal studies to differ, given the slight differences between trials? A: Jon Congleton, CEO: It's hard to predict, but Advance-HTN is a more rigorous study with confirmed uncontrolled or resistant hypertension, potentially enriched for aldosterone-dependent hypertension. Launch-HTN is confirmatory to Target-HTN.
Q: How do you view the threshold for hyperkalemia rates in Advance and Launch, and what needs to be shown to be differentiated in the clinic? A: David Rodman, CMO: The FDA focuses on benefit-risk rather than p-values. Ensuring patients take their thiazides improves benefit-risk by increasing response and decreasing potassium.
Q: Can you speak more about the mechanism expectations for ASI benefit in obstructive sleep apnea patients? A: David Rodman, CMO: The goal is to address resistant hypertension driven by hypoxia. The drug targets aldosterone-dependent mechanisms, potentially reducing arrhythmias and improving blood pressure control.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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