Sleep Apnea Syndromes

STOCKHOLM, SE / ACCESSWIRE / April 4, 2024 / AlzeCure Pharma (STO:ALZCUR)(FRA:AC6) AlzeCure Pharma AB (publ) (FN STO:ALZCUR), a pharmaceutical company that develops a broad portfolio of small molecule candidate drugs for diseases affecting the central nervous system, with projects in both Alzheimer's disease and pain, today announced that its Annual Report for 2023 has been published. "2023 continued to be positive and eventful for AlzeCure Pharma. During the year, we presented positive proof-ofmechanism (POM) results from our Phase II clinical study with ACD440 for the treatment of neuropathic pain. Further, we chose a new candidate drug for our Alzheimer's project, Alzstatin, and we also published new preclinical data for our clinical drug candidate NeuroRestore ACD856, which supports neuroprotective and disease-modifying effects. This advancement is highly relevant for treatment of Alzheimer's and other neurodegenerative diseases. We were also granted patents for ACD856 in additional territories, such as in Europe and Japan, further strengthening our business development opportunities. Furthermore, we have now also selected a drug candidate in our TrkA-NAM project, ACD137. It is both motivating and gratifying that we are keeping up the pace as we continue to deliver new data that strengthen our position," says Martin Jönsson, CEO of AlzeCure Pharma. The Annual Report is attached as a PDF and is available on the company's website, For more information, please contact Martin Jönsson, CEO Tel: +46 707 86 94 43 martin.jonsson@alzecurepharma.com About AlzeCure Pharma AB (publ) AlzeCure® is a Swedish pharmaceutical company that develops new innovative drug therapies for the treatment of severe diseases and conditions that affect the central nervous system, such as Alzheimer's disease and pain - indications for which currently available treatment is very limited. The company is listed on Nasdaq First North Premier Growth Market and is developing several parallel drug candidates based on three research platforms: NeuroRestore®, Alzstatin® and Painless. NeuroRestore consists of two symptomatic drug candidates where the unique mechanism of action allows for multiple indications, including Alzheimer's disease, as well as cognitive disorders associated with traumatic brain injury, sleep apnea and Parkinson's disease, as well as for depression treatment. The Alzstatin platform focuses on developing disease-modifying and preventive drug candidates for early treatment of Alzheimer's disease and comprises two drug candidates. Painless is the company's research platform in the field of pain and contains two projects: ACD440, which is a drug candidate in the clinical development phase for the treatment of neuropathic pain, and TrkA-NAM, which targets severe pain in conditions such as osteoarthritis. AlzeCure aims to pursue its own projects through preclinical research and development through an early clinical phase, and is continually working on business development to find suitable outlicensing solutions, alternatively partnership, with other pharmaceutical companies. FNCA Sweden AB is the company's Certified Adviser. For more information, please visit . Attachments Alzecure AR 2023 ENG Final SOURCE: AlzeCure Pharma View the original press release on accesswire.com

The Centers for Medicare & Medicaid Services' previous changes to payments haven't been enough to stem the tide of declining patient access to supplemental oxygen that continues to grow nationwide, particularly in rural and underserved areas. Nationwide, an estimated 1.5 million Americans rely on supplemental oxygen to help treat and manage a range of respiratory and pulmonary conditions and disorders, from severe asthma and pneumonia to sleep apnea, chronic obstructive pulmonary disease and cystic fibrosis. That’s why recent challenges in the availability and delivery of supplemental oxygen are so alarming for patients living with pulmonary and respiratory disease as well as their loved ones.  In response, a bipartisan group of lawmakers in the U.S. Congress—led by Sens. Bill Cassidy, R-Louisiana, Mark Warner, D-Virginia, and Amy Klobuchar, D-Minnesota, in the Senate; and Reps. David Valadao, R-California, Julia Brownley, D-California, Larry Bucshon, M.D., R-Illinois, and Adrian Smith, R-Nebraska, in the House—introduced the Supplemental Oxygen Access Reform (SOAR) Act (S. 3821/ H.R. 7829), bipartisan legislation to help improve patient access to life-sustaining supplemental oxygen therapy. Bipartisan lawmakers in the House are considering this legislation as well. Just as a doctor may prescribe varying dosage levels or forms of a medication to treat different patients based on their individual needs, there are several different forms of and ways to deliver supplemental oxygen, each with its own strengths and limitations. Since supplemental oxygen was added to Medicare’s competitive bidding program, claims for all forms of oxygen have dropped drastically, with no major changes in respiratory disease rates or patterns to explain such a significant decrease. In the pulmonary health community, this has raised red flags. Recognizing harm to patient access, the Centers for Medicare & Medicaid Services previously made some minor updates to supplemental oxygen payments by establishing new payment classes. However, these weren’t enough to stem the tide of declining patient access to supplemental oxygen that continues to grow nationwide, particularly in rural and underserved areas. Even Medicare has acknowledged these access issues and continues to monitor the impact of its payment policy.  Now, with more than three years of the pandemic exacerbating these access issues, Medicare beneficiaries are struggling to get the necessary oxygen and equipment they need. In turn, limited access to supplemental oxygen is preventing patients with a range of health conditions from achieving optimal outcomes and living the highest quality of life possible based on their diagnosis.  That is why comprehensive oxygen reform is urgently needed for patients, caretakers, healthcare providers and communities—and why the SOAR Act (S. 3821/H.R. 7829) is such a welcome development. This bill—endorsed by several patient organizations—will help increase and ensure patient access to supplemental oxygen and respiratory therapy to protect and improve health and quality of life. Among many much-needed reforms, this bill would remove supplemental oxygen and related equipment from the Medicare competitive bidding program. Instead, it would establish new, separate payment rates and methodologies for both non-liquid and liquid oxygen that better reflect patients’ needs and differences in oxygen modality.  The SOAR Act would also help protect and expand Medicare beneficiaries’ access to respiratory therapists by creating a new add-on for their services to the supplemental oxygen rate. This small but important change would make it easier and more affordable for patients struggling with a range of pulmonary and respiratory disorders to access and benefit from the care only trained respiratory therapists can offer to patients during treatment and recovery. Additionally, by directing Medicare to move toward a standardized, electronic template for documenting medical necessity for supplemental oxygen, this much-needed and long-overdue solution would help simplify and streamline the unnecessarily long and complicated process of retroactively reviewing a patient’s medical record to prove medical necessity. This change, along with the establishment of a Medicare beneficiary bill of rights, would further increase access and reduce delays in care that can undermine patient outcomes. The access issues patients and providers are experiencing with supplemental oxygen will only increase unless Congress takes decisive action to reform Medicare’s oxygen payment policies. Congress should seize this opportunity and pass the SOAR Act. Dan Starck is the interim chair of the Council for Quality Respiratory Care, a coalition of the nation’s leading home oxygen therapy providers and manufacturing companies.

CAMBRIDGE, Mass., April 03, 2024 (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, including its lead oral treatment candidate AD109, today announced the company will participate in the 23rd Annual Needham Virtual Healthcare Conference taking place virtually on April 8-11, 2024. Apnimed’s management will participate in a fireside chat on April 10 from 12:45 pm to 1:25 pm ET and will be available for one-on-one virtual meetings during the conference. Investors can view the webcast of the presentation using this link. A replay will be available after the conference on the Apnimed website events page. About AD109AD109 has the potential to be the first oral pharmacologic that could both treat the underlying nighttime airway obstruction and hypoxia that characterize OSA, as well as improve the daytime consequences of OSA, such as fatigue. 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. AD109 combines Apnimed’s novel selective antimuscarinic (aroxybutynin) with a selective norepinephrine reuptake inhibitor (atomoxetine). AD109 targets key neurological pathways in OSA that activate upper airway dilator muscles to maintain an open airway during sleep. AD109 has the potential to become a safe, effective, and convenient treatment for OSA, addressing some of the key limitations of approved treatments that can be poorly tolerated (e.g., CPAP and oral devices) and/or invasive (e.g., surgery or implanted devices). AD109 has been granted Fast Track designation by the FDA and is currently in Phase 3. About Obstructive Sleep ApneaObstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 50 million Americans, though underdiagnosis continues to be a serious problem and the number of affected Americans may be far greater. OSA is characterized by partial or complete upper airway closure that occurs during sleep, which can cause dramatic reductions in overnight oxygen saturation and often leads to poor sleep, and in the long term, has been shown to exacerbate hypertension, diabetes, cardiovascular disease, and stroke. Additionally, OSA can impair work productivity, reduce daytime functional abilities, and lower quality of life. Sleep-related muscular relaxation driven by the central nervous system is the key neurologic mechanism that causes OSA. In patients with OSA, a reduction in neuromuscular control of the upper airway during sleep leads to a corresponding relaxation of the upper airway dilator muscles. The vast majority of diagnosed patients are prescribed positive air pressure therapy devices such as continuous positive airway pressure, or CPAP, but many patients are dissatisfied with these mechanical nighttime devices and fewer than half are compliant long term, leaving a significant population untreated, undertreated and at risk. Some OSA patients are overweight or obese, and sustained weight loss can reduce the severity of airway collapse and some symptoms. However, even substantial weight loss has not been shown to be curative in most patients or reduce the need for treatments that help maintain an open airway during sleep. About ApnimedApnimed is a clinical-stage pharmaceutical company working to transform the treatment of sleep apnea based on a simple idea – patients with obstructive sleep apnea could benefit from treatment with a safe and effective oral medication dosed once daily at bedtime. Apnimed’s lead development program, AD109, targets the neurologic control of upper airway muscles to maintain an open airway during sleep. Based in Cambridge, Mass., the company is developing a portfolio of novel pharmacologic therapies for sleep apnea and related disorders. Apnimed has a pipeline of novel, oral pharmacologic programs including several that are part of a partnership with Shionogi & Co., Ltd. in our Shionogi-Apnimed Sleep Science, LLC Joint Venture. Learn more at apnimed.com or follow us on X and LinkedIn. Media Contact:Amanda BreedingScientPRamanda@scientpr.com Investor Contact:Wendy GabelKendall Investor Relationswgabel@kendallir.com