Latest news with #Apnimed
Business Upturn
4 days ago
- Health
- Business Upturn
Obstructive Sleep Apnea Clinical Trial Pipeline Expands as 12+ Companies Driving Innovation in OSA Therapeutics
By GlobeNewswire Published on July 16, 2025, 22:00 IST New York, USA, July 16, 2025 (GLOBE NEWSWIRE) — Obstructive Sleep Apnea Clinical Trial Pipeline Expands as 12+ Companies Driving Innovation in OSA Therapeutics | DelveInsight The obstructive sleep apnea (OSA) market is being propelled by the rapid evolution of early detection and diagnostic tools. Technologies like home sleep apnea testing (HSAT), AI-powered applications, and smart wearables are transforming the diagnostic landscape by making it more accessible and user-friendly. These innovations not only reduce the dependency on traditional sleep labs but also facilitate earlier diagnosis and timely intervention. As a result, more patients are entering the treatment pathway, supporting both improved clinical outcomes and sustained market expansion. DelveInsight's 'Obstructive Sleep Apnea Pipeline Insight 2025' report provides comprehensive global coverage of pipeline obstructive sleep apnea therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the obstructive sleep apnea pipeline domain. Key Takeaways from the Obstructive Sleep Apnea Pipeline Report DelveInsight's obstructive sleep apnea pipeline report depicts a robust space with 12+ active players working to develop 14+ pipeline obstructive sleep apnea drugs. active players working to develop pipeline obstructive sleep apnea drugs. Key obstructive sleep apnea companies such as Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, KYORIN Pharmaceutical Co., Shionogi Apnimed Sleep Science , and others are evaluating new obstructive sleep apnea drugs to improve the treatment landscape. and others are evaluating new obstructive sleep apnea drugs to improve the treatment landscape. Promising pipeline obstructive sleep apnea therapies, such as Sulthiame, IHL-42X, Lorundrostat, Retatrutide, BAY2925976, SASS-001, and others, are in different phases of obstructive sleep apnea clinical trials. and others, are in different phases of obstructive sleep apnea clinical trials. In June 2025 , Innovent Biologics, Inc. announced that the first participant had been successfully dosed in a Phase III clinical trial (GLORY-OSA) of Mazdutide , a dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese participants with moderate-to-severe obstructive sleep apnea (OSA) and obesity (BMI ≥ 28 kg/m2). , announced that the first participant had been successfully dosed in a Phase III clinical trial (GLORY-OSA) of , a dual glucagon (GCG) and glucagon-like peptide-1 (GLP-1) receptor agonist, in Chinese participants with and obesity (BMI ≥ 28 kg/m2). In April 202 5, Apnimed announced that the first patient had been dosed in the Phase IIA RESTEADY trial evaluating the novel oral drug combination, SASS-001 , in an underserved population of patients suffering from sleep apnea with a central component. Top-line results from the study are expected in the first half of 2026. SASS-001 represents the first clinical stage asset from Shionogi-Apnimed Sleep Science, LLC (SASS), Apnimed's joint venture with Shionogi & Co., Ltd. (Shionogi). 5, announced that the in the Phase IIA RESTEADY trial evaluating the novel oral drug combination, , in an underserved population of patients suffering from sleep apnea with a central component. Top-line results from the study are expected in the first half of 2026. SASS-001 represents the first clinical stage asset from Shionogi-Apnimed Sleep Science, LLC (SASS), Apnimed's joint venture with Shionogi & Co., Ltd. (Shionogi). In April 2025 , Shionogi & Co., Ltd. announced that it had entered into an agreement with Apnimed, Inc. for the introduction of sulthiame * and a new drug development program. With the conclusion of this agreement, Shionogi acquired a joint ownership interest in the intellectual property rights related to the use of sulthiame in the field of sleep apnea and also in other intellectual property rights related to a different drug development program of Apnimed by paying a one-time fee to Apnimed. , Shionogi & Co., Ltd. announced that it had entered into an with for the introduction of * and a new drug development program. With the conclusion of this agreement, Shionogi acquired a joint ownership interest in the intellectual property rights related to the use of sulthiame in the field of sleep apnea and also in other intellectual property rights related to a different drug development program of Apnimed by paying a one-time fee to Apnimed. In April 2025 , Apnimed announced that it had acquired the intellectual property and exclusive global rights to develop and commercialize sulthiame , a differentiated carbonic anhydrase inhibitor, in the broad field of sleep apnea and sleep-related breathing diseases, from D esitin Arzneimittel GmbH . Apnimed will develop sulthiame with Shionogi & Co. Ltd. through their joint venture, Shionogi-Apnimed Sleep Science (SASS). , announced that it had to develop and commercialize , a differentiated carbonic anhydrase inhibitor, in the broad field of and sleep-related breathing diseases, from D . Apnimed will develop sulthiame with Shionogi & Co. Ltd. through their joint venture, Shionogi-Apnimed Sleep Science (SASS). In April 2025 , Incannex Healthcare Inc. announced that the Company has completed Phase II patient enrollment in the global Phase II/III RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality. , announced that the Company has in the global Phase II/III RePOSA study of IHL-42X for the treatment of Obstructive Sleep Apnea (OSA). IHL-42X is an oral fixed dose combination medicine designed to reduce the incidence of interruptions to breathing during sleep and improve sleep quality. In January 2025, Mineralys Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) had cleared the Company's Investigational New Drug (IND) Application for a Phase II clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. Request a sample and discover the recent advances in obstructive sleep apnea drugs @ Obstructive Sleep Apnea Pipeline Report The obstructive sleep apnea pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Obstructive Sleep Apnea drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the obstructive sleep apnea clinical trial landscape. Obstructive Sleep Apnea Overview Obstructive sleep apnea (OSA) is a sleep disorder marked by repeated episodes of partial or complete blockage of the upper airway during sleep. These episodes cause drops in oxygen levels and frequent awakenings, resulting in fragmented, poor-quality sleep. Common signs include loud snoring, witnessed pauses in breathing, and excessive daytime sleepiness. OSA can have wide-ranging health effects, impairing cardiovascular health, behavior, quality of life, and even driving safety. While other types of sleep-disordered breathing, such as central sleep apnea, upper airway resistance syndrome, and obesity hypoventilation, share some features with OSA, they are distinct conditions and will be discussed separately. The symptoms of OSA vary and can severely impact day-to-day functioning. These include persistent daytime drowsiness, loud snoring, gasping or choking during sleep, morning headaches, dry mouth or sore throat upon waking, difficulty concentrating, mood disturbances such as irritability or depression, high blood pressure, and reduced libido. These manifestations can greatly affect both physical well-being and overall life quality. The underlying cause of OSA involves upper airway obstruction during sleep, mainly due to negative pressure that causes the airway to collapse during inhalation. A key area of concern is the narrowing of the airway in the retropalatal region during exhalation. Obesity is a significant risk factor, with a higher body mass index (BMI) linked to greater airway narrowing. Both structural factors (like airway size) and neuromuscular control contribute to this condition. Understanding how airflow interacts with pressure in collapsible airways is vital to grasping the mechanics of OSA. Additional anatomical and physiological factors also influence the severity of the disorder. Managing OSA requires a personalized and multifaceted approach. For mild-to-moderate cases, lifestyle changes, such as losing weight, maintaining good sleep habits, and avoiding alcohol and sedatives, are important first steps. Continuous positive airway pressure (CPAP) therapy is the most effective treatment for moderate-to-severe OSA, though adherence can be difficult. Alternatives like oral appliances, especially mandibular advancement devices, may help in less severe cases. Surgical options, including uvulopalatopharyngoplasty (UPPP), maxillomandibular advancement (MMA), and hypoglossal nerve stimulation (HNS), may be considered for more severe or treatment-resistant cases. In rare, severe situations, a tracheostomy may be necessary, particularly for patients with significant comorbidities. Ultimately, the best outcomes are achieved through an individualized treatment plan that may combine several strategies to relieve symptoms, improve sleep quality, and enhance overall health. Find out more about obstructive sleep apnea drugs @ Obstructive Sleep Apnea Treatment A snapshot of the Pipeline Obstructive Sleep Apnea Drugs mentioned in the report: Drugs Company Phase MoA RoA AD109 Apnimed III Adrenergic uptake inhibitors; Cholinergic receptor antagonists; Muscarinic receptor antagonists Oral Retatrutide Eli Lilly and Company III Gastric inhibitory polypeptide receptor agonists; Glucagon receptor agonists; Glucagon-like peptide-1 receptor agonists Subcutaneous IHL-42X Incannex Healthcare Ltd II/III Cannabinoid receptor CB2 agonists; Carbonic anhydrase inhibitors Oral Lorundrostat Mineralys Therapeutics Inc. II Aldosterone synthase inhibitors Oral Sulthiame Apnimed II Carbonic anhydrase inhibitors Oral SASS-001 Shionogi Apnimed Sleep Science II Purinergic P2X3 receptor antagonists Oral Learn more about the emerging obstructive sleep apnea therapies @ Obstructive Sleep Apnea Clinical Trials Obstructive Sleep Apnea Therapeutics Assessment The obstructive sleep apnea pipeline report proffers an integral view of the emerging obstructive sleep apnea therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action. Scope of the Obstructive Sleep Apnea Pipeline Report Coverage : Global : Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action : Adrenergic uptake inhibitors, Cholinergic receptor antagonists, Muscarinic receptor antagonists, Cannabinoid receptor CB2 agonists, Carbonic anhydrase inhibitors, Aldosterone synthase inhibitors, Glucagon-like peptide-1 receptor agonists, Purinergic P2X3 receptor antagonists : Adrenergic uptake inhibitors, Cholinergic receptor antagonists, Muscarinic receptor antagonists, Cannabinoid receptor CB2 agonists, Carbonic anhydrase inhibitors, Aldosterone synthase inhibitors, Glucagon-like peptide-1 receptor agonists, Purinergic P2X3 receptor antagonists Key Obstructive Sleep Apnea Companies : Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, KYORIN Pharmaceutical Co., Shionogi Apnimed Sleep Science, and others. : Apnimed, Incannex Healthcare Ltd, Mineralys Therapeutics Inc., Eli Lilly and Company, KYORIN Pharmaceutical Co., Shionogi Apnimed Sleep Science, and others. Key Obstructive Sleep Apnea Pipeline Therapies: Sulthiame, IHL-42X, Lorundrostat, Retatrutide, BAY2925976, SASS-001, and others. Dive deep into rich insights for new obstructive sleep apnea treatments, visit @ Obstructive Sleep Apnea Drugs Table of Contents 1. Obstructive Sleep Apnea Pipeline Report Introduction 2. Obstructive Sleep Apnea Pipeline Report Executive Summary 3. Obstructive Sleep Apnea Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Obstructive Sleep Apnea Clinical Trial Therapeutics 6. Obstructive Sleep Apnea Pipeline: Late-Stage Products (Pre-registration) 7. Obstructive Sleep Apnea Pipeline: Late-Stage Products (Phase III) 8. Obstructive Sleep Apnea Pipeline: Mid-Stage Products (Phase II) 9. Obstructive Sleep Apnea Pipeline: Early-Stage Products (Phase I) 10. Obstructive Sleep Apnea Pipeline Therapeutics Assessment 11. Inactive Products in the Obstructive Sleep Apnea Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the Obstructive Sleep Apnea Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix For further information on the obstructive sleep apnea pipeline therapeutics, reach out @ Obstructive Sleep Apnea Therapeutics Related Reports Obstructive Sleep Apnea Epidemiology Forecast Obstructive Sleep Apnea Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted obstructive sleep apnea epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Obstructive Sleep Apnea Market Obstructive Sleep Apnea Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key obstructive sleep apnea companies, including Apnimed, Eli Lilly and Company, Nyxoah Inc., ICUREsearch, Eisai Inc., Purdue Pharma LP, Desitin Arzneimittel GmbH, Berendo Scientific LLC, Sumitomo Pharma America Inc., Apnex Medical Inc., among others. Sleep Apnea Market Sleep Apnea Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key sleep apnea companies, including Apnimed, Incannex Healthcare, Fujian Shengdi Pharmaceutical, Eli Lilly and Company, RespireRx Pharmaceuticals, Neurim Pharmaceuticals, among others. Sleep Apnea Pipeline Sleep Apnea Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key sleep apnea companies, including Apnimed, Incannex Healthcare, Fujian Shengdi Pharmaceutical, Eli Lilly and Company, RespireRx Pharmaceuticals, Neurim Pharmaceuticals, among others. Sleep Apnea Diagnostic Devices Market Sleep Apnea Diagnostic Devices Market Insights, Competitive Landscape and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key sleep apnea diagnostic devices companies, including Natus Medical Incorporated., SOMNOmedics GmbH, Compumedics Limited, ZOLL Itamar Ltd., Nihon Kohden Corporation, Vyaire., Cleveland Medical Devices Inc., Cadwell Industries Inc., Koninklijke Philips N.V., InMode Aesthetic Solutions, ResMed, Resonea, DeVilbiss Healthcare LLC, Smiths Group Plc. (Smiths Medical), Hemodiaz Life Sciences Private Limited., ActiGraph, LLC., Advin Health Care, Recorders & Medicare Systems Pvt Ltd (RMS), Allengers, EB Neuro S.p.A., among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Forbes
30-06-2025
- Health
- Forbes
First Pill For Obstructive Sleep Apnea Shows Promise In Phase 3 Study
The American Academy of Sleep Medicine has indicated that an estimated 26 percent of adults between ... More the ages of 30 and 70 years have sleep apnea. (Photo: Getty) You could say that it's difficult to mask the challenges that people with obstructive sleep apnea face every day. But if this pill from Apnimed, Inc. eventually gets approved by the U.S. Food and Drug Administration, it could give those OSA sufferers who are having trouble wearing a continuous positive airway pressure mask while sleeping another option. Apnimed recently announced rather eye-opening topline results from the SynAIRgy phase 3 clinical trial of their AD109 pill. A little over half (51.2%) of the study participants who took the once-a-day pill had a reduction in their OSA severity while nearly a quarter (22.3%) experienced achieved complete OSA control. Obstructive Sleep Apnea Affects A Quarter Of The Adult Population More options would probably be a welcome possibility for the over 25 million adults in the U.S. who suffer from OSA, based on the National Healthy Sleep Awareness Project. The American Academy of Sleep Medicine has indicated that an estimated 26 percent of adults between the ages of 30 and 70 years have sleep apnea. That may be an underestimate because people are kind of asleep when they are experiencing signs and symptoms of OSA. It could take someone else trying to share a bed with you to tell you that you are snoring or even gasping for breath when you are asleep. OSA is one type of sleep apnea. Sleep apnea is when you repeatedly stop and start breathing while sleeping. Its important to know if this is happening because breathing is sort of important. Sleep apnea can lead to sleep deprivation, which, in turn, can lead to daytime drowsiness and over the longer term various chronic medical conditions, as I've described previously in Forbes. One such condition is high blood pressure, which in turn can raise the risk of heart disease and stroke. OSA is when the apnea is due to your throat muscles relaxing too much and blocking your airway. That's why one possible sign of OSA is snoring, which can occur when air tries to pass through the narrowed airway. The following illustration shows what can happen to the airway with OSA: (Illustration: Getty) Here Are The Current Treatment Options For Obstructive Sleep Apnea All of the currently available treatment options for OSA are focused on one thing: keep that airway open as much as possible. Changes in sleep position could help. For example, sleeping on your side, particularly the left side, can keep the airway open better than sleeping on your back. the latter can allow your tongue and soft palate to collapse into your airway. One oft-mentioned treatment option is the CPAP mask. The name is a clue to what it does. You wear a mask that will continuously will blow air into your nose or nose and mouth. That air is supposed to provide positive pressure to keep your airways open, sort of like blowing air into one of those balloons that can become a balloon animal. Although a variety of such masks are available, wearing such a mask throughout the night may not necessarily be the most pleasant, comfortable or sexy thing. Another option is some kind of mouthpiece designed to keep the throat open during sleep. Some such devices thrust your lower jaw forward. Other such devices hold your tongue is particular positions. When OSA gets particularly severe, surgery may be needed. This could be surgery to remove excess tissue in the neck that may be blocking the airway or move forward the jaw bones to give more space behind the tongue and soft palate. Life-threatening cases of OSA may even require a tracheostomy, which is when a hole is made in your throat and a breathing tube is inserted there. Now you may have heard about one of the glucagon-like peptide-1 receptor agonists, Zepbound, getting FDA-approval for severe OSA. This would be mainly for folks who have OSA due mainly to obesity. Excess fatty tissue in the neck can indeed predispose you to OSA. Therefore, weight loss can be helpful in reducing OSA. However, many people suffer from OSA do not have excess body weight. For many, it's just the anatomy of the airway and the way the nerves happen to be working or not working that allows too much collapse of the airway. The Apnimed Pill Could Become The First Prescription Pull For Obstructive Sleep Apnea This brings us to how AD109 is supposed to work. The medication is a combo of 2.5 mg of aroxybutynin, a new type of antimuscarinic, and 75 mg atomoxetine, which inhibits the reuptake of the neurotransmitter norepinephrine, thereby increasing the time it spends in between nerves. These work to increase the nerve signals sent through the hypoglossal motor nucleus that control the muscles in the upper airway. The medication has already gone through more than 15 Phase 1 and 2 clinical trials. A Phase 2b clinical trial named MARIPOSA showed that those taking AD109 experienced statistically significant reductions in their AHIs. AHI stands for apnea-hypopnea index, a commonly used measure of how severe sleep apnea is. The AHI is the average number of apneas, which are complete pauses in breathing, and hypopneas, which are partial reductions in breathing, that happen per hour of sleep during a sleep study. Normally, this should be less than five. Having five to 14 such events per hour classifies you as having mild sleep apnea. When this goes up to 15 to 29, it's moderate sleep apnea. The severe range is 30 or more such events per hour. Next up was the SynAIRgy trial, a randomized, double blind, placebo-controlled, parallel-arm of the medication designed to extend for six months. It included 646 adult study participants with OSA who either couldn't tolerate or didn't want to use CPAP. Around half (49.1%) of the study participants were women. At the beginning of the trial, 34.4% had mild OSA, 42.2% moderate and 23.2% severe. Patrick Strollo, Jr., MD, Vice Chair of Medicine for Veteran's Affairs and a Professor of Medicine at the University of Pittsburgh School of Medicine. served as the study chair of SynAIRgy. Strollo described the results so far as 'highly encouraging." At the 26-week mark in the SynAIRgy trial, those taking AD109 every day had on average a 55.6% reduction in their AHI. As mentioned previously, 51.2% actually dropped in sleep apnea disease severity categories with 22.3% going to the no apnea category, namely less than five events per hour. Those taking AD109 also on average had improvements in the amount of oxygen they were getting into their blood via their lungs. There were also no AD109-related serious adverse events with the medication in general being well-tolerated. Topline results from a second Phase 3 clinical trial, LunAIRo, will probably be available by the third quarter of 2025. All of this means that the company is currently on track to submit a New Drug Application for AD109 to the FDA by early 2026. If it reaches the market, AD109 would be the first prescription pill specifically for obstructive sleep apnea—which, again, affects quite a lot of people out there, probably much more than people realize. So don't sleep on what happens next.
Yahoo
21-05-2025
- Business
- Yahoo
Morgan Stanley sees ‘modest' earnings impact to ResMed from Apnimed
Morgan Stanley analyst David Bailey keeps an Overweight rating on ResMed (RMD) with a $286 price target after Apnimed provided topline results as part of its Phase 3 trial for AD109, focused on the treatment of obstructive sleep apnea. Participants treated with AD109 recorded a mean Apnea-Hypopnea Index reduction of 55.6% from baseline, the analyst tells investors in a research note. The firm believes AD109 appears to focus on patients who are unable or refuse to tolerate continuous positive airway pressure, or CPAP. Further, patients who record an AHI less than 10 appear to be those with mild to moderate sleep apnea, the analyst tells investors in a research note. On balance, Morgan Stanley sees a 'modest' potential earnings impact for ResMed based on current data from Apnimed. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks straight to you inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See the top stocks recommended by analysts >> Read More on RMD: Disclaimer & DisclosureReport an Issue Apnimed data brings competitive threat to ResMed, says RBC Capital Resmed's Growth Potential Highlighted by Promising Trial Results and Future Opportunities Buy Rating for Resmed: Positive Phase 3 Trial Results and Market Conditions Boost AD109's Appeal GOOGL, RMD: TipRanks' New AI Analyst Tool Reveals 2 Stocks for Potential Growth ResMed named Sleep Partner of the Qatar Airways British & Irish Lions Tour Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Hans India
20-05-2025
- Health
- Hans India
Wearable sensor can monitor obstructive sleep apnea treatment response
New Delhi: Wearable Pulse Oximeter, Obstructive Sleep Apnea, Sleep Monitoring, Medical Device, Digital Health, Patient Care A wearable pulse oximeter and connected software platform show promise for monitoring obstructive sleep apnea (OSA) and other sleep-related breathing diseases, according to new research released. The device (pulse oximeter), which is cleared for medical use, was designed for comfort and ease of use; a clinical trial found high rates of utilisation by patients. It could be used to track patient response to OSA treatment over time. 'Investigators in our clinical research trials report how useful longitudinal data are to observe night-to-night variability and the response to treatment of OSA,' said Ketan Mehta, head of product and engineering for Connected Wearables at Apnimed. 'One sleep specialist even reported that it may be better to collect one or two channels of data over 25 nights than 25 channels over one night, which is considered the gold standard with in-lab polysomnography,' Mehta added. Wearable sensors like the Oura ring and Apple Watch that measure biometrics during sleep are widely used by consumers, but are not cleared for medical use. At the same time, other medical devices used in sleep studies gather clinically relevant data, but are too cumbersome and costly to use for frequent monitoring. This tool could potentially expand patient access to care through pulmonologists to manage routine sleep apnea in their patients, instead of having to refer them out to a sleep specialist, he added. The device provides a bridge between these two extremes, he said. Worn as a ring, the device offers several key differences from other consumer wearables. Notably, it uses transmittance-based photoplethysmography, which has been shown to be more suitable for the proximal phalanx region, provide better signal-to-noise ratio, and is more effective in low perfusion situations. It also engages in continuous data collection, rather than spot checks, he added. The device connects to an app that users can access from their smartphone, giving patients access to a subset of the same data as their health care providers. 'These data empower both parties to be informed, and they're able to have more meaningful conversations. This offers the opportunity for shared decision making between patient and provider using digital medicine,' Mehta said.
Yahoo
19-05-2025
- Health
- Yahoo
Apnimed Announces Positive Topline Results in the First Landmark Phase 3 Clinical Trial of AD109, an Investigational Once-daily Oral Pill for Obstructive Sleep Apnea
AD109 met the primary endpoint, mean change in apnea-hypopnea index (AHI, p=0.001) at 26 weeks, across a broad range of people with mild, moderate and severe obstructive sleep apnea Study participants treated with AD109 achieved a mean reduction in AHI of 55.6% from baseline and achieved significantly improved oxygenation and reduced disease severity AD109 is a first-in-class, anti-apneic neuromuscular modulator which targets the root cause of OSA by increasing upper airway muscle tone during sleep Apnimed expects topline results in Q3'25 from its second Phase 3 clinical trial, LunAIRo, and plans to submit an NDA to the U.S. FDA for AD109 by early 2026 CAMBRIDGE, Mass., May 19, 2025 /PRNewswire/ -- Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed's lead candidate AD109 (aroxybutynin 2.5mg/atomoxetine 75mg) in adults living with mild, moderate and severe OSA, and across all weight classes. The SynAIRgy trial met its primary endpoint: mean change from baseline in the apnea-hypopnea index (AHI) at 26 weeks compared to placebo (p=0.001). The topline results for the primary and multiple secondary endpoints were similar to the results observed in the previous 4-week MARIPOSA Phase 2b clinical trial. AD109 was generally well-tolerated, and the most common adverse events were consistent with earlier AD109 clinical trials. No serious adverse events related to AD109 were reported in the SynAIRgy trial. An estimated 80 million people in the United States and one billion people worldwide are living with OSA. OSA is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. AD109 is designed to target the neurobiology of the hypoglossal motor nucleus by increasing signals to the upper airway muscles during sleep, leading to the reduction or prevention of upper airway collapse. "Today is a landmark moment for Apnimed and for millions living with OSA who have long struggled with limited treatment options," said Larry Miller, MD, Chief Executive Officer of Apnimed. "The positive results from our Phase 3 SynAIRgy trial bring us closer to realizing our vision of offering a simple, safe, and effective oral drug — one that is grounded in science, driven by unmet need, and centered on people with OSA. We believe these results represent the dawn of a new era in the OSA treatment paradigm. We are deeply grateful to the patients, investigators, and clinical teams whose partnership and commitment made this achievement possible. Importantly, these results increase our confidence in the expected outcome of the second Phase 3 clinical trial, LunAIRo, with topline results expected in Q3'25." Additional Efficacy ResultsIn addition to meeting the primary endpoint, AD109 also demonstrated improvements in other secondary and exploratory endpoints, including: Meaningful improvements in oxygenation as assessed by hypoxic burden (p<0.0001) and oxygen desaturation index (p=0.001) 51.2% of participants treated with AD109 showed a reduction in OSA disease severity category 22.3% of participants treated with AD109 achieved complete OSA disease control (defined as AHI <5 events/hour) "These Phase 3 topline results are highly encouraging and represent the potential for a much-needed innovation in the treatment of OSA," said Patrick Strollo, Jr., MD, study chair of the SynAIRgy clinical trial and Vice Chair of Medicine for Veteran's Affairs at the University of Pittsburgh School of Medicine. "For too long, progress in OSA has been limited, leaving many people with OSA without sustainable treatment options. The results from SynAIRgy suggest that if approved, AD109 could offer a compelling new treatment option — a novel oral drug that targets the neuromuscular root cause of airway obstruction in sleep apnea and holds promise for transforming care for a broad range of patients." "OSA should be considered a top public health priority: it is a serious, common, chronic disease that affects a wide range of people, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity," said Monica Mallampalli, PhD, President and CEO of the Alliance of Sleep Apnea Partners. "There is a vast need for new treatment options. We welcome innovations like this, which are long overdue for our patient community. The SynAIRgy results offer people hope that an oral therapy is on the horizon that could make it easier for them to manage their OSA and reclaim their lives." Advancing AD109Apnimed plans to submit a New Drug Application (NDA) for AD109 to the U.S. Food and Drug Administration (FDA) by early 2026 for regulatory review. The full data for SynAIRgy will be presented at a medical congress later this year and published in a peer-reviewed scientific journal. Apnimed also anticipates the availability of topline data in Q3 2025 from the second Phase 3 LunAIRo trial, a one-year study of AD109 in adults with OSA. About the SynAIRgy StudyThe SynAIRgy study (NCT05813275) was a randomized, double blind, placebo-controlled, parallel-arm six-month clinical trial of AD109, a fixed dose combination of aroxybutynin 2.5mg/atomoxetine 75mg, in participants with OSA who are intolerant of or currently refuse continuous positive airway pressure (CPAP) therapy. The trial enrolled 646 adult participants from 73 centers in the US and Canada. Participants were randomized 1:1 to either AD109 or placebo and instructed to take their assigned treatment once-daily before bedtime. SynAIRgy is the largest Phase 3 clinical trial of a medication to treat OSA. Enrolled participants in SynAIRgy were representative of the real-world patient population, including the diverse demographic composition of the United States and the typical profiles seen in a sleep clinic population. Participants included 49.1% females, multiple racial groups, and varied weight classes spanning healthy weight, overweight, and with obesity. Participants were distributed across OSA severity levels, including mild (34.4%), moderate (42.4%), and severe (23.2%). Participants had symptoms reflective of the OSA patient experience. About AD109AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with obstructive sleep apnea. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI). Their combined pharmacological synergy targets the underlying neuromuscular cause of OSA. AD109 is a once-daily pill taken at bedtime that is designed to lower the complexity of intervention and may help more people benefit from effective, restorative sleep. In a disease characterized by complex and invasive treatment options, AD109 may be a simple solution to help improve oxygenation and health wellbeing for people living with OSA. About Obstructive Sleep ApneaObstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. It is caused by two overlapping mechanisms: neuromuscular dysfunction during sleep and predisposing anatomic abnormalities. OSA affects individuals across all walks of life, impacting both males and females of all age groups, ethnicities, and weight classes, including those with or without obesity. An estimated 80 million people in the United States and one billion people worldwide suffer from OSA. Up to 80% of people living with OSA are undiagnosed and therefore untreated. An individual with OSA can experience hundreds of sleep apnea events in a single night, each one reducing the blood oxygen levels and negatively impacting cellular functions vital to normal health and function. Failure to effectively treat OSA increases the risk of serious long-term health consequences, including cardiovascular disease, neurocognitive impairment, metabolic dysfunction, and early mortality. Yet, the majority of those diagnosed with OSA refuse, abandon, or underutilize treatment. Currently, no available pharmacological treatments directly address the underlying neuromuscular dysfunction that is present in OSA. About ApnimedApnimed is a privately held clinical-stage pharmaceutical company dedicated to transforming the treatment landscape for sleep-related breathing diseases. We believe the introduction of simple, once-nightly oral drugs has the potential to dramatically expand diagnosis and the reach of treatment for people with OSA. OSA, like other common chronic diseases such as diabetes or hypertension, would benefit from having multiple drugs with differing mechanisms to more fully address the heterogeneity of disease pathophysiology. Apnimed envisions a new era where novel oral therapies simplify intervention, expand the reach of diagnosis and treatment, and help more people get the oxygen and restorative sleep needed to thrive. Based in Cambridge, Mass., Apnimed is advancing a robust pipeline of oral pharmaceutical product candidates designed to improve oxygenation in individuals living with OSA and other sleep-related breathing disorders. Our lead candidate, AD109, could become the catalyst for a new oral treatment paradigm for OSA that has been historically limited to cumbersome devices or invasive surgeries. AD109 is currently in Phase 3 clinical trials for the treatment of mild, moderate and severe OSA. Apnimed is also developing several therapies as part of its joint venture with Shionogi & Co., Ltd., Shionogi-Apnimed Sleep Science. Learn more at or follow us on X and LinkedIn. Media Contact: media@ Investor Contact:ir@ View original content to download multimedia: SOURCE Apnimed, Inc. Sign in to access your portfolio
