Latest news with #Apnimed
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
Yahoo
08-04-2025
- Business
- Yahoo
Apnimed doses first subject in trial for sleep apnoea with central component
US-based Apnimed has dosed the first subject in the multi-centre Phase IIA RESTEADY trial of SASS-001, an oral drug combo for sleep apnoea with a central component. SASS-001 is a combination of selective P2X3 receptor antagonist, sivopixant, and another compound. The randomised, controlled, dose-escalation, double-blind, parallel-arm trial is intended for underserved individuals with this condition. It aims to enrol about 60 subjects at up to ten clinical sites in the US. Subjects are set to be randomised to a dose-escalating arm of the therapy or a placebo arm. They will take part in the trial for a ten-week period, with study measures including sleep-clinic polysomnography as well as at-home sleep assessments. SASS-001 comes from Apnimed's joint venture (JV) with Shionogi, named Shionogi-Apnimed Sleep Science (SASS), as its first clinical-stage asset. The JV aims at expediting the discovery, preclinical and clinical development of pharmacologic solutions for addressing the pathology of sleep apnoea and other sleep-related conditions. Apnimed CEO Larry Miller said: 'With the first patient dosed in the Phase IIA RESTEADY trial, both Apnimed and SASS have reached an important milestone – the advancement of a scientific hypothesis to clinical development. 'Today's announcement represents the combined efforts of the Apnimed and Shionogi teams, highlighting their respective strengths in sleep medicine drug development and drug discovery.' In parallel, AD109, the company's clinical programme, is advancing after the enrolment conclusion in its Phase III trials, LunAIRo and SynAIRgy, with these trials' top-line data expected in the second and third quarters of this year, respectively. AD109 is under evaluation in obese and non-obese adults with mild, moderate, and severe obstructive sleep apnoea (OSA). In May 2023, the company reported positive outcomes from the MARIPOSA Phase IIb trial of AD109 for the treatment of OSA. "Apnimed doses first subject in trial for sleep apnoea with central component" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
08-04-2025
- Business
- Yahoo
Apnimed doses first subject in trial for sleep apnoea with central component
US-based Apnimed has dosed the first subject in the multicentre Phase IIA RESTEADY trial of SASS-001, an oral drug combo for sleep apnoea with a central component. SASS-001 is a combination of selective P2X3 receptor antagonist, sivopixant, and another compound. The randomised, controlled, dose-escalation, double-blind, parallel-arm trial is intended for underserved individuals with this condition. It aims to enrol about 60 subjects at up to ten clinical sites in the US. Subjects are set to be randomised to a dose-escalating arm of the therapy or a placebo arm. They will take part in the trial for a ten-week period, with study measures including sleep-clinic polysomnography as well as at-home sleep assessments. SASS-001 comes from Apnimed's joint venture (JV) with Shionogi, named Shionogi-Apnimed Sleep Science (SASS), as its first clinical-stage asset. The JV aims at expediting the discovery, preclinical and clinical development of pharmacologic solutions for addressing the pathology of sleep apnoea and other sleep-related conditions. Apnimed CEO Larry Miller said: 'With the first patient dosed in the Phase IIA RESTEADY trial, both Apnimed and SASS have reached an important milestone – the advancement of a scientific hypothesis to clinical development. 'Today's announcement represents the combined efforts of the Apnimed and Shionogi teams, highlighting their respective strengths in sleep medicine drug development and drug discovery.' In parallel, AD109, the company's clinical programme, is advancing after the enrolment conclusion in its Phase III trials, LunAIRo and SynAIRgy, with these trials' top-line data expected in the second and third quarters of this year, respectively. AD109 is under evaluation in obese and non-obese adults with mild, moderate, and severe obstructive sleep apnoea (OSA). In May 2023, the company reported positive outcomes from the MARIPOSA Phase IIb trial of AD109 for the treatment of OSA. "Apnimed doses first subject in trial for sleep apnoea with central component" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
