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Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with Hypertension
– Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30-50% of adults with hypertension, both conditions associated with
About this update from Mineralys Therapeutics, Inc.
[{"type":"text","content":"– Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30-50% of adults with hypertension, both conditions associated with excess morbidity and mortality – – Obstructive sleep apnea represents Mineralys’ third precision, targeted indication for lorundrostat, further expanding its market potential in aldosterone-driven diseases – – Initiation of the trial anticipated in the first quarter of 2025 – RADNOR, Pa., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by dysregulated aldosterone, today 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 st...