Mineralys Therapeutics (MLYS) Stifel 2024 Healthcare Conference summary

Industry trends and unmet needs

• Growing recognition of underdiagnosed hyperaldosteronism and its link to obesity and resistant hypertension.

• European guidelines now recommend aldosterone testing for all hypertension patients, reflecting a shift in diagnostic focus.

• U.S. specialists are increasingly aware of the aldosterone-obesity connection, though diagnostic practices lag behind Europe.

Clinical program insights

• Target-HTN established proof of concept for lorundrostat, showing significant aldosterone and blood pressure reduction with a favorable safety profile.

• Operational lessons from Target-HTN informed the design and measurement techniques for pivotal studies.

• Advance-HTN targets truly uncontrolled/resistant patients on standardized regimens, while Launch-HTN reflects real-world use among generalists.

• Both pivotal studies require all patients to be on diuretics, leveraging mechanistic synergy for better outcomes.

Study design and endpoints

• Advance-HTN uses 24-hour ambulatory blood pressure monitoring to minimize placebo effect and ensure robust data.

• Launch-HTN employs in-office measurements with rigorous training to reduce variability and placebo response.

• Both studies are powered to detect a 7 mm Hg reduction, with subset analyses for obesity and resistance.

• Two-thirds of Advance-HTN participants have BMI over 30, supporting analysis of obesity-related effects.