A phase 2 trial will evaluate the drug’s potential to reduce upper airway obstruction and nocturnal hypertension in patients with moderate-to-severe OSA.

Summary: Mineralys Therapeutics has received FDA clearance for a phase 2 clinical trial of lorundrostat, a drug designed to address moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The trial aims to assess lorundrostat’s ability to reduce upper airway obstruction and nocturnal hypertension, conditions linked to poor cardiovascular outcomes. The placebo-controlled study will enroll approximately 40 participants and utilize advanced sleep monitoring technology to gather data on its safety and efficacy.

Key Takeaways:

  1. FDA Clears Trial for Dual-Targeting Drug: The phase 2 trial will explore lorundrostat’s efficacy in addressing both moderate-to-severe OSA symptoms and nocturnal hypertension.
  2. Study Design: The trial will employ a crossover, placebo-controlled approach and continuous blood pressure monitoring during sleep studies to assess the drug’s impact on sleep and cardiovascular health.
  3. Focus on Unmet Needs: By addressing OSA and hypertension, lorundrostat targets two interconnected conditions with few effective treatment options, aiming to improve outcomes for patients struggling with both disorders.

Mineralys Therapeutics Inc, a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease, and other diseases driven by dysregulated aldosterone, announced that the US Food and Drug Administration 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,” says Jon Congleton, chief executive officer of Mineralys Therapeutics, in a release. “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.”

Evaluating Safety and Efficacy of Lorundrostat

The planned phase 2 clinical trial is a placebo-controlled, crossover study to evaluate the safety and efficacy of lorundrostat 50 mg 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 the 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 blood pressure monitoring during the performance of a standard sleep study without the benefit of CPAP. Standard patient-reported outcomes, specific to OSA will also be assessed.

“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,” says Reena Mehra, MD, MS, a sleep disorders researcher and physician and new member of the Mineralys Scientific Advisory Board, in a release. “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 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.

ID 73745697 © Vchalup | Dreamstime.com