[{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Successfully Completes Phase 1 Study in Lead Program for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in Phase 2 Clinical Trial with AD109, Lead Candidate for Treatment of Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 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(OSA)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Alpha Wave Ventures","pharmaFlowCategory":"D","amount":"$79.7 million","upfrontCash":"Undisclosed","newsHeadline":"Apnimed Completes Oversubscribed $79.75 Million Series C Extension Financing to Fund Two Planned Phase 3 Trials of AD109, an Oral Medication with the Potential to Be the First Therapy for Direct Treatment of Obstructive Sleep Apnea (OSA)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Find Clinical Drug Pipeline Developments & Deals by Apnimed
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep Apnea.
The joint venture will initially focus on accelerating the discovery, preclinical and clinical development of novel pharmacologic solutions designed to address the complex pathology of obstructive sleep apnea.
AD109 (atomoxetine) 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.
AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.
AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity.
AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], p=0.003 on AD504.
Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.
AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.
Apnimed’s lead product candidate, AD109, targets the neurologic control and facilitates the activation of the upper airway dilator muscles to maintain an open airway during sleep.
The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage Phase 2 clinical trials.
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