US FDA Nods Mineraly's Phase 2 Trial for Lorundrostat in Hypertension

Mineralys Therapeutics, Inc., a biopharmaceutical company in clinical development concentrating on creating therapies for hypertension, chronic kidney disease (CKD), and other ailments linked to dysregulated aldosterone, revealed that the US Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for a phase 2 clinical trial to assess the impact of lorundrostat in treating individuals with moderate-to-severe obstructive sleep apnoea (OSA) and hypertension. The company expects to commence the trial in the first quarter of 2025.

The upcoming phase 2 clinical trial is a crossover, placebo-controlled study designed to assess the safety and effectiveness of lorundrostat 50mg administered once daily in the evening to around 40 individuals with moderate-to-severe OSA. Participants must be at least 18 years of age, with a BMI of 27 kg/m2, and the study will take place at around 40 locations.

“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.”