-- LunAIRo Compares AD109 to Placebo Over 6 and 12 Months in People with OSA who Are Intolerant of or Refuse Positive Airway Pressure (PAP) Therapy, the Current Standard of Care -- -- Second registrational Phase 3 study, SynAIRgy, to begin enrollment in 4th quarter -- CAMBRIDGE, Mass., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Apnimed, Inc., a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, today announced the first patient dosed in its LunAIRo Phase 3 study designed to examine the efficacy and safety of AD109 (aroxybutynin/atomoxetine) compared to placebo at six-months and one year.

--LunAIRo将AD109与安慰剂进行了6个月和12个月的OSA患者比较，这些患者不能耐受或拒绝气道正压通气（PAP）治疗，这是目前的护理标准-第二次注册3期研究，SynAIRgy，开始注册第四季度-马萨诸塞州剑桥市，2023年9月21日（全球新闻报道）-Apnimed，Inc。，一家临床阶段制药公司专注于开发用于治疗阻塞性睡眠呼吸暂停（OSA）和相关疾病的口服药物疗法，今天宣布第一名患者在其LunAIRo 3期研究中服用，旨在检查AD109（aroxybutynin）的疗效和安全性。/阿托西汀）与安慰剂相比，为期6个月和1年。

AD109 has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy. “There is an urgent need for new treatment options for people with OSA, particularly those who cannot tolerate currently available therapies,” said Sanjay Patel, M.D., primary investigator in the LunAIRo clinical study and Director, UPMC Comprehensive Sleep Disorders Clinical Program in Pittsburgh, Pennsylvania.

AD109有可能成为OSA患者不耐受或拒绝使用气道正压通气（PAP）治疗的第一次夜间口服药物治疗。LunAIRo临床研究的主要研究人员和宾夕法尼亚州匹兹堡UPMC综合睡眠障碍临床项目主任Sanjay Patel博士说：“迫切需要为OSA患者提供新的治疗方案，特别是那些不能耐受现有疗法的患者。”。

“It's vital to discover and test alternative treatments for people with OSA to potentially help improve their quality of life both at night and during the day. Based on the results, AD109 has the potential to be a major game changer in how we treat OSA.” Currently, fewer than half of the people using PAP therapy are compliant long-term, leaving many people at risk from the consequences of untreated OSA, including a higher risk for stroke and heart attack.

“发现和测试OSA患者的替代疗法至关重要，可能有助于改善他们在夜间和白天的生活质量。根据结果​​，AD109有可能成为我们如何治疗OSA的主要游戏改变者。”目前，使用巴氏治疗的人中不到一半是长期依从的，使许多人面临未经治疗的OSA后果的风险，包括中风和心脏病发作的风险较高。

“LunAIRo and SynAIRgy, our second registrational study expected to begin enrollment in the fourth quarter, represent the largest ever prosp.

“我们的第二项注册研究LunAIRo和SynAIRgy预计将于第四季度开始注册，这是有史以来规模最大的prosp。