Jan. 8, 2025 — Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases, has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The Company anticipates initiating the trial in the first quarter of 2025.
“We are pleased to announce the OSA clinical development program for lorundrostat. This program aligns with our strategy to develop lorundrostat in conditions driven by dysregulated aldosterone, with poor cardiovascular outcomes and few treatment options,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We believe suppression of aldosterone production by lorundrostat has the potential to reduce the nocturnal hypertension driving adverse cardiovascular outcomes. In addition, lorundrostat is anticipated to reduce the severity of upper airway obstruction and associated OSA symptoms such as daytime sleepiness and cognitive impairment.”
“Obstructive sleep apnea carries significant physiological and psychological impacts on health. Along with trouble sleeping, excessive daytime sleepiness and snoring from repetitive upper airway closure, patients frequently experience significant surges in blood pressure overnight contributing to the daytime hypertension that most are struggling to control,” stated Reena Mehra, MD, MS, a sleep disorders researcher and physician and new member of the Mineralys Scientific Advisory Board. “We designed the OSA trial in collaboration with a group of thought leaders in sleep apnea treatment in order to incorporate state-of-the-art technology, register sites with expertise in sleep medicine, and pinpoint the right participants to ensure high-quality data that are reflective of real-world unmet needs facing these patients. I look forward to conducting this innovative trial with Mineralys and our academic partners over the coming months.”
The planned Phase 2 clinical trial is a placebo-controlled, crossover study to evaluate the safety and efficacy of lorundrostat 50mg taken once daily in the evening in approximately 40 subjects with moderate-to-severe OSA. Subjects will be at least 18 years old, with a BMI ≥27 kg/m2, and the trial will be conducted across approximately 40 sites.
The key objective of this trial is to validate the hypothesis that lorundrostat both alleviates the severity of upper airway obstruction and reduces nocturnal hypertension. The primary outcome measure is absolute change in the frequency of apnea-hypopnea episodes. The key secondary objective is to quantify blood pressure throughout the night using continuous BP monitoring during performance of a standard sleep study without the benefit of CPAP. Standard patient reported outcomes, specific to OSA will also be assessed.
The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials, and support its corporate operations through the first quarter of 2026.
Additional information is available at https://mineralystx.com/.
December 19, 2024 
