Obstructive Sleep Apnea treatment
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Mineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
Globenewswire· 2025-09-30 12:00
Core Insights - Mineralys Therapeutics has completed enrollment in its Phase 2 EXPLORE-OSA trial for lorundrostat, targeting patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension, with top-line results expected in Q1 2026 [1][2] - The trial aims to address the significant unmet need for effective treatments for patients suffering from OSA and hypertension, as current options are limited and often ineffective [2][3] - Lorundrostat is a selective aldosterone synthase inhibitor designed to reduce aldosterone levels, which are linked to hypertension and related comorbidities [8][9] Company Overview - Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing treatments for hypertension, chronic kidney disease (CKD), and OSA, driven by dysregulated aldosterone [9] - The company is based in Radnor, Pennsylvania, and was founded by Catalys Pacific [9] Trial Details - The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover study evaluating the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe OSA and hypertension [3] - Participants will receive 50 mg of lorundrostat or placebo, with the primary efficacy endpoint being the change in apnea-hypopnea index (AHI) after four weeks of treatment [3] Disease Context - OSA affects nearly one billion people globally, with 425 million cases classified as moderate-to-severe, and around 80% of adults with OSA remain undiagnosed [4] - Hypertension is a major health issue, contributing to over 685,000 deaths in the U.S. in 2022, with an estimated economic burden of $219 billion in 2019 [6] Market Opportunity - Between 30-50% of adults with hypertension have OSA, and this figure rises to 70-80% in those with resistant hypertension (rHTN) [5] - There is a significant opportunity for lorundrostat to address the needs of patients with both hypertension and OSA, particularly given the limitations of current treatment options [2][5]
Nyxoah Provides an Update on Expanded Middle East Presence
Globenewswire· 2025-09-23 20:10
Core Insights - Nyxoah is expanding its presence in the Middle East with new centers in Dubai, Kuwait, and Abu Dhabi, following the first successful Genio® implant in the region in September 2025 [2][4]. Company Overview - Nyxoah is a medical technology company focused on developing innovative solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio system, a leadless and battery-free hypoglossal neurostimulation therapy [5][6]. - The Genio system received its European CE Mark in 2019 and has undergone successful IPOs on Euronext Brussels and NASDAQ [6]. Market Expansion - The Middle East is identified as a significant and growing market for Nyxoah, with the company partnering with leading healthcare institutions to enhance access to the Genio solution for OSA patients who cannot tolerate CPAP [3][4]. - The expansion into Kuwait and Abu Dhabi is part of Nyxoah's strategy to broaden its commercial footprint and improve patient outcomes in the region [4].