RADNOR, PA — Mineralys Therapeutics, Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a Phase 2 clinical trial to evaluate lorundrostat for treating obstructive sleep apnea (OSA) and hypertension. The trial is set to begin in the first quarter of 2025.
The study’s primary aim is to assess whether lorundrostat, a once-daily oral medication, can reduce the frequency of apnea-hypopnea episodes in patients with moderate-to-severe OSA while also providing meaningful reductions in nocturnal hypertension. This novel approach targets dysregulated aldosterone, which plays a central role in driving poor cardiovascular outcomes in these patients.
Chief Executive Officer Jon Congleton emphasized the significance of the program, stating, “This development aligns with our strategy to address cardiovascular conditions influenced by aldosterone dysregulation. Lorundrostat has the potential to reduce both nocturnal blood pressure surges and the severity of airway obstructions that define sleep apnea.”
Patients with OSA often face challenges beyond disrupted sleep, including severe daytime fatigue, cognitive difficulties, and spikes in blood pressure that heighten cardiovascular risks. The planned Phase 2 trial, which will enroll approximately 40 participants across 40 sites, is designed to explore these interconnected health issues in detail. Using advanced technology and continuous blood pressure monitoring during overnight sleep studies, the trial aims to generate high-quality data that could shape future treatments.
Dr. Reena Mehra, a prominent sleep disorders researcher and member of the Mineralys Scientific Advisory Board, highlighted the broader implications of the study. “Obstructive sleep apnea and the associated surges in blood pressure present significant challenges for patients. This trial has been carefully developed to address key gaps in managing the condition, ensuring robust real-world relevance,” she stated.
Participants will take lorundrostat once daily during the evening in a placebo-controlled, crossover design study. Beyond monitoring sleep apnea symptoms, the trial will focus on blood pressure trends and patient-reported outcomes specific to OSA, offering a comprehensive assessment of the medication’s potential benefits.
Mineralys also confirmed that its current financial resources are projected to sustain the company through the first quarter of 2026, enabling it to move forward with its planned trials and operational goals. If successful, lorundrostat could bring new hope to patients struggling with OSA and hypertension, two conditions with significant unmet medical needs.
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