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For the first time, patients with alcohol use disorder will receive the company's unique and proprietary psychedelic - MEAI Feb. 23, 2024 -- Clearmind Medicine Inc. (Nasdaq, CSE: CMND), (FSE: CWY) (“Clearmind” or the "company"), a biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, is pleased to announce it has received approval from the Ministry of Health of Israel to commence its phase I/IIa clinical trial for alcohol use disorder (AUD) patients using the company's proprietary MEAI-based (5-methoxy-2-aminoindane) CMND-100 oral capsule. "We are thrilled to receive approval to commence our phase I/IIa clinical trial for our lead drug candidate, CMND-100, which has been shown to be safe and effective in preclinical studies. This is the most important milestone for the company to date and marks our transition to a clinical- stage pharmaceutical company. The Clearmind team has been working tirelessly on the research and development of a novel treatment to the global epidemic of alcoholism. We are eager to continue our work with patients in need of help,” said Dr. Adi Zuloff-Shani, CEO of Clearmind Medicine. “Our non-hallucinogenic, psychedelic solution could be the answer to the tremendous global need for groundbreaking, dedicated and effective treatments for addictions." The clinical trial is a multinational, multi-center, single and multiple dose tolerability, safety and pharmacokinetic study of CMND-100 in healthy volunteers and AUD subjects. The Israeli study will be led by Prof. Mark Weiser, M.D., head of the Psychiatric Division at the Sheba Medical Center in the Tel Aviv suburb of Ramat Gan. The company intends to have two additional sites in the United States for the phase I/IIa clinical trial, at the Yale School of Medicine’s Department of Psychiatry and the Johns Hopkins University School of Medicine. The primary endpoint of the clinical trial is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics of single and repeated doses of CMND-100 in healthy subjects and those with AUD. The secondary endpoint is to evaluate preliminary efficacy of CMND-100 in reduction of drinking patterns and cravings in individuals with moderate-to-severe AUD. Oral capsules will be administered and subjects treated by these oral capsules will report their drinking patterns and cravings for alcohol during the clinical trial. The active ingredient in CMND-100 is MEAI, an innovative, psychoactive and non-hallucinogenic molecule that has been reported to reduce the desire to consume alcoholic beverages, while exerting a slight euphoric alcohol-like experience. MEAI was found to interact with the serotonergic receptors 5-HT1a and 5-HT2a. The serotonergic system is considered to play a key role in the regulation of alcohol intake, reward, preference, and dependence. MEAI was also found to interact with the alpha-2-adrenergic receptors α2A, α2B and α2C, as well as the plasma membrane monoamine transporters for dopamine (DAT), norepinephrine (NET) and serotonin (SERT). These receptors and transporters are believed to participate in mediating alcohol drinking behavior and could constitute important molecular targets for interventions that target drugs subject to abuse, such as alcohol. Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of fifteen patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio. Shares of Clearmind are listed for trading on Nasdaq and the Canadian Securities Exchange under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY.” The content above comes from the network. if any infringement, please contact us to modify.

-- New Post-Hoc Analysis of MARIPOSA Data on Estimating OSA Endotypes from theOxyhemoglobin Saturation Signal in Patients Dosed with AD109 for 1 Month -- Exploratory Trial on the Impact of Investigational Combination AD113 on OSA Severity and Blood Pressure in Hypertensive Patients CAMBRIDGE, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic therapies for the treatment of obstructive sleep apnea (OSA) and related disorders, announced that a post-hoc analysis of data from the MARIPOSA Phase 2b trial, an efficacy, safety and dose-finding study for AD109 (aroxybutynin/atomoxetine) of one-month duration, will be featured at a poster presentation at the European Respiratory Society’s (ERS) International Congress 2023 in Milan, Italy. A second poster will also be presented on a small exploratory, proof-of-concept trial for another potential compound, AD113 (atomoxetine/mineralocorticoid receptor antagonist), exploring OSA severity and blood pressure in hypertensive patients. “ERS 2023 is an opportunity to share the latest data on our investigational oral treatments for obstructive sleep apnea with respiratory experts from around the globe,” said Larry Miller, MD, Chief Executive Officer of Apnimed. “We are excited to be on the forefront of moving the science forward for potential pharmacologic options for OSA to support the millions of people around the world who are unable or unwilling to use currently available treatments.” Presentation Details: POSTER:PA1280Session:145 - Basic and clinical science in sleep breathing disorders: a bidirectional relationshipTime: Sunday, September 10, 12:30-14:00 CESTLocation:Allianz MiCo, PS-6 in poster areaPresenter:Luigi Taranto Montemurro, MD, Chief Scientific Officer, Apnimed POSTER:PA3597Session:355 - From basic to translational sleep breathing disordersTime: Monday, September 11, 16:00- 17:30 CESTLocation:Allianz MiCo, PS-5 in poster areaPresenter: Ludovico Messineo, MD, PhD, Associate Professor ASN, Harvard Medical School About AD109AD109 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. It is a potential 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 current standard of care 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. About Obstructive Sleep Apnea Obstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 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. 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 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. 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

CAMBRIDGE, Mass., Aug. 30, 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, including its lead oral treatment candidate AD109, announced today the company will be participating in several investor conferences in September 2023. Please see additional details below: Citi 18th Annual BioPharma Conference: September 7, 2023, taking place at the Four Seasons Hotel, Boston, MA. Lawrence Miller, MD, CEO will participate in a fireside chat from 10:30-11:15 AM ET in the Aujourd’hui Room. The event is open to all conference attendees. Baird Global 2023 Healthcare Conference: September 12, 2023, taking place at the InterContinental New York Barclay, NY. Barry Wohl, CBO will present from 11:25-11:55 AM ET in Session IV, Morgan Suite and participate in 1x1 meetings. 2023 Cantor Fitzgerald Global Healthcare Conference: September 28, 2023, taking place at the InterContinental New York Barclay, NY. Barry Wohl, CBO, will present from 9:10-9:40 AM ET in Track 4 and participate in 1x1 meetings. A live webcast may be accessed using the following link: https://wsw.com/webcast/cantor19/apni/2082696. Interested parties may also access the webcast on the “Events” section of the company website at: apnimed.com/events. About AD109 AD109 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. It is a potential 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 current standard of care 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. About Obstructive Sleep ApneaObstructive Sleep Apnea is one of the most common and serious sleep disorders. It is estimated to affect more than 45 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. 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 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. In January 2023, Apnimed raised $79.75M in a Series C extension for a total of $208 M since the company's inception and is financed by a strong syndicate of biotech investors. 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