Delusions

Copayment and Premium Assistance Available to Eligible Patients with Government Insurance GERMANTOWN, Md., Oct. 28, 2024 /PRNewswire/ -- The HealthWell Foundation®, an independent non-profit charitable organization that provides financial assistance for underinsured Americans, announced today that it has launched a new fund to assist governmentally-insured people living with schizophrenia. Through the fund, HealthWell will provide up to $4,000 in medication copayment or insurance premium assistance to eligible people with household incomes up to 500 percent of the federal poverty level. Schizophrenia is a spectrum of serious neuro-psychiatric brain diseases in which people interpret reality abnormally. It may result in some combination of hallucinations, delusions and extremely disordered thinking and behavior that impairs daily life. Schizophrenia and related psychosis disorders affect at least 1 in 100 people in the United States – or about 2 million adults. People with schizophrenia typically require lifelong treatment. "Stigma and lack of effective treatment options can play a detrimental role in the proper diagnosis and treatment for people living with schizophrenia," said Suzanne M. Miller, PhD., Professor, Cancer Prevention & Control, Fox Chase Cancer Center/Temple University Health System, and HealthWell Foundation Board Vice Chair and Secretary. "Often times, diagnosis requires a multitude of tests because symptoms can vary from person to person. Providing financial resources that enable people to access and remain on prescribed treatments is a huge step forward in ensuring management of their disease. We are excited to launch the new fund and strengthen our commitment to assisting patients with mental health conditions." "Access to proper and sustained treatment is crucial to managing this complex brain disease, including helping to prevent relapses and allowing people to live the meaningful lives they deserve," said Gordon Lavigne, Chief Executive Officer of the Schizophrenia & Psychosis Action Alliance. "People with schizophrenia who are on Medicare can be particularly challenged by the costs of managing their disease, as they may need multiple medications, and the copays alone can add up quickly. The HealthWell Foundation provides an invaluable service by recognizing the obstacles our community faces and offering financial support to ease their recovery journey." To determine eligibility for assistance, visit HealthWell's Schizophrenia – Medicare Access Fund page. Note that all new fund openings and fund re-openings occur at 11:00 a.m. Eastern Daylight Time (8:00 a.m. Pacific) Monday through Friday. To learn more about HealthWell programs and our robust portfolio of disease funds, visit HealthWellFoundation.org. About the Schizophrenia & Psychosis Action Alliance The Schizophrenia & Psychosis Action Alliance works to shatter the barriers to treatment, survival and recovery for people living with schizophrenia. Every day without treatment can mean the difference between life and death. The organization's mission is to advance systemic change and promote recovery through Research, Education & Care and Advocacy & Public Policy. With proper treatment and support, many people with schizophrenia can achieve recovery, including returning to work or school, having a family, enjoying friendships and social activities and engaging in a meaning-driven life. We envision a day when the understanding of schizophrenia as a brain disease allows every person living with it to be treated with respect, access appropriate treatment and have the opportunity to recover. To learn more, please visit . About the HealthWell Foundation A nationally recognized, independent non-profit organization founded in 2003 and a resource to the White House Cancer Moonshot Initiative, the HealthWell Foundation has served as a safety net across over 90 disease areas for more than one million underinsured patients. Since its inception, HealthWell has provided over $4 billion in financial support through more than 1.5 million grants to access life-changing medical treatments patients otherwise would not be able to afford. HealthWell provides financial assistance to adults and children facing medical hardship resulting from gaps in their insurance that cause out-of-pocket medical expenses to escalate rapidly; HealthWell assists with the treatment-related cost-sharing obligations of these patients. HealthWell ranked 23rd on the 2023 Forbes list of America's Top 100 Charities and was recognized for its 100 percent fundraising efficiency. For more information, visit HealthWellFoundation.org. CONTACT: Ginny Dunn 240-632-5309 [email protected] SOURCE HealthWell Foundation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Part A of the placebo-controlled Phase 2 study has been completed ANAVEX®3-71 demonstrates a dose-dependent pharmacodynamic effect on objective EEG biomarkers of schizophrenia Patients are currently being dosed in Part B of the Phase 2 study which will investigate a longer treatment duration Oct. 17, 2024 -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today announced encouraging preliminary electroencephalography (EEG) biomarker results from the Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Part A of the Phase 2 study ANAVEX®3-71-SZ-001 (NCT06245213), was a multiple ascending dose study in 16 participants treated with either oral placebo, oral ANAVEX®3-71 90 mg daily, or oral ANAVEX®3-71 180 mg daily for 10 days. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia. Treatment with ANAVEX®3-71 compared to placebo resulted in improvements in 40 Hz Auditory Steady-State Response (ASSR) Inter Trial Coherence (ITC) and Resting State Alpha Power, both of which were increased. These effects were most pronounced in the higher dose group demonstrating a dose-dependent pharmacodynamic effect. These results provide evidence of CNS target engagement and potential therapeutic effects of ANAVEX®3-71 in schizophrenia. The observed changes reversed known EEG and ERP biomarker abnormalities associated with schizophrenia1. These EEG biomarkers correlate with positive, negative, and cognitive symptoms of schizophrenia. Individuals with schizophrenia typically have reduced neural synchrony as measured by 40 Hz ASSR ITC. Improvements in 40 Hz ASSR ITC indicate enhanced neural synchronization, potentially leading to reduced auditory hallucinations (positive symptom), improved executive function, and working memory (cognitive symptoms).2 Individuals with schizophrenia also typically have decreased resting state alpha power correlating with sensory and behavioral problems. Increases in Resting State Alpha Power reflect improvements in thalamocortical circuits and sensory gating, potentially resulting in reduced irritability and anxiety (negative symptoms).3 “We are pleased to see an initial effect of biomarkers changing in people with schizophrenia treated with our oral M1/SIGMAR1 therapy ANAVEX®3-71, which could eventually help patients address both positive, negative, and cognitive symptoms of schizophrenia,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “The results are encouraging for further development of ANAVEX®3-71 for people with schizophrenia.” ANAVEX®3-71 was well tolerated, with no serious adverse events reported. Oral ANAVEX®3-71 is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects. This novel mechanism of action offers the potential to treat all symptom domains of schizophrenia without the side effects of standard of care antipsychotics. ANAVEX®3-71 has previously demonstrated long-lasting, pro-cognitive effects and behavioral improvements in animal models of neurodegenerative diseases4,5, an ability to prevent cognitive decline in animal models6,7, and has shown robust safety signals in healthy volunteers at single doses ranging from 5 to 200 mg once daily.8,9 Recent research into the genetic underpinnings of schizophrenia has revealed links between this psychiatric disorder and neurodegenerative disease, suggesting the disorders may share certain mechanisms.10 Oral ANAVEX®3-71, in addition to the M1 muscarinic receptor activity, the combined SIGMAR1 receptor activity might offer a novel mechanism of action that may address multiple symptom domains without the motor side effects associated with traditional antipsychotics. The currently ongoing Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, will provide more comprehensive data on the efficacy and safety of ANAVEX®3-71 in schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study in the first half of 2025. Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 34% of people do not respond to therapy, 11 with an additional 50-60% experiencing only a partial improvement in symptoms or unacceptable side effects.12 Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn. 1 Cecchi M, Adachi M, Basile A, et al. Validation of a suite of ERP and QEEG biomarkers in a pre-competitive, industry-led study in subjects with schizophrenia and healthy volunteers. Schizophr Res. 2023;254:178-189. doi:10.1016/j.schres.2023.02.018 2 Parker DA, Hamm JP, McDowell JE, et al. Auditory steady-state EEG response across the schizo-bipolar spectrum. Schizophr Res. 2019;209:218-226. doi:10.1016/j.schres.2019.04.014 3 Newson JJ, Thiagarajan TC. EEG Frequency Bands in Psychiatric Disorders: A Review of Resting State Studies. Front Hum Neurosci. 2019;12:521. Published 2019 Jan 9. doi:10.3389/fnhum.2018.00521 4 Fisher A, Bezprozvanny I, Wu L, et al. AF710B, a Novel M1/σ1 Agonist with Therapeutic Efficacy in Animal Models of Alzheimer’s Disease. Neurodegener Dis. 2016;16(1-2):95-110. doi:10.1159/000440864 5 Hall H, Iulita MF, Gubert P, et al. AF710B, an M1/sigma-1 receptor agonist with long-lasting disease-modifying properties in a transgenic rat model of Alzheimer's disease. Alzheimers Dement. 2018;14(6):811-823. doi:10.1016/j.jalz.2017.11.009 6 https://www.anavex.com/post/anavex-life-sciences-reports-new-publication-in-scientific-journal-demonstrating-the-potential-of 7 Orciani C, Do Carmo S, Foret MK, et al. Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology [published online ahead of print, 2023 Sep 26]. Neurobiol Aging. 2023;132:220-232. doi:10.1016/j.neurobiolaging.2023.09.010 8 Fadiran EO, Hammond E, Tran J, et al. Concentration-QTc Relationship from a Single Ascending Dose Study of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for the Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease. Clin Pharmacol Drug Dev. 2023;12(9):888-901. doi:10.1002/cpdd.1303 9 Fadiran EO, Hammond E, Tran J, Missling CU, Ette E. Population-Based Characterization of the Pharmacokinetics and Food Effect of ANAVEX3-71, a Novel Sigma-1 Receptor and Allosteric M1 Muscarinic Receptor Agonist in Development for Treatment of Frontotemporal Dementia, Schizophrenia, and Alzheimer Disease. Clin Pharmacol Drug Dev. 2024;13(1):21-31. doi:10.1002/cpdd.1323 10 Guo P, Meng C, Zhang S, et al. Network-based analysis on the genes and their interactions reveals link between schizophrenia and Alzheimer's disease. Neuropharmacology. 2024;244:109802. doi:10.1016/j.neuropharm.2023.109802 11 Potkin SG, Kane JM, Correll CU, et al. The neurobiology of treatment-resistant schizophrenia: paths to antipsychotic resistance and a roadmap for future research. NPJ Schizophr. 2020;6(1):1. Published 2020 Jan 7. doi:10.1038/s41537-019-0090-z 12 Nucifora FC Jr, Woznica E, Lee BJ, Cascella N, Sawa A. Treatment resistant schizophrenia: Clinical, biological, and therapeutic perspectives. Neurobiol Dis. 2019;131:104257. doi:10.1016/j.nbd.2018.08.016 The content above comes from the network. if any infringement, please contact us to modify.

Cobenfy introduces a new mechanism of action to the schizophrenia treatment landscape and an additional option for patients. Credit: 13_Phunkod via Shutterstock. The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb ’s first-in-class schizophrenia drug Cobenfy (xanomeline-trospium), providing patients with a new treatment option not seen in decades. The novel drug – named Cobenfy – introduces a new mechanism of action to the schizophrenia treatment landscape by targeting cholinergic receptors as opposed to dopamine receptors. The market for schizophrenia drugs has long been dominated by dopamine-blocking antipsychotics, which are associated with significant side effects such as Parkinsonian symptoms, sexual dysfunction, and weight gain. Originally developed by Karuna Therapeutics and named KarXT, BMS inherited the drug as part of a $14bn acquisition, which was finalised in March 2024. The acquisition is set to pay off as Cobenfy is set to pull in $2.99bn in sales in 2030, according to GlobalData forecasts. GlobalData is the parent company of Pharmaceutical Technology . Cobenfy is a twice-daily pill that combines two drugs: one that targets muscarinic receptors M1 and M4, which increase activity in the parasympathetic nervous system, and another that lessens side effects from activating those receptors. Clinical trial data has shown that the drug relieves symptoms such as delusions without some of the drastic side effects caused by currently approved antipsychotics. See Also: Boehringer Ingelheim opens $66.8m new cancer research facility AskBio and Belief BioMed partner to advance gene therapies The excitement surrounding Cobenfy also stems from its ability to address both the positive and negative symptoms of schizophrenia. Unlike dopamine receptors, M1 and M4 receptors work on positive symptoms such as hallucinations and delusions, and negative symptoms that include reduced emotional output, speech, and motivation. Data from the Phase III EMERGENT-3 trial (NCT04738123) showed that the drug demonstrated an 8.4-point reduction in Positive and Negative Syndrome Scale (PANSS) total score compared to placebo at week five.  However, the new drug comes with side effects like any other therapy. The prescribing information includes warnings that Cobenfy can cause urinary retention, increased heart rate, decreased gastric movement, or angioedema (swelling beneath the skin) of the face and lips. In the announcement accompanying the approval, Tiffany Farchione, director of the Division of Psychiatry, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research said: “This drug takes the first new approach to schizophrenia treatment in decades. This approval offers a new alternative to the antipsychotic medications people with schizophrenia have previously been prescribed.” Some experts have expressed concerns about the twice-daily dosing schedule of the drug, noting that treatment effectiveness often depends on consistent medication adherence – something that can be difficult for schizophrenia patients, especially given the side effects of traditional antipsychotics. However, in a Q1 2023 earnings call, Karuna’s former CEO Bill Meury suggested that adherence to Cobenfy could surpass standard schizophrenia treatments. To tackle this issue, Terran Biosciences are developing a prodrug version of xanomeline-trospium, called TerXT. Terran’s candidates keep Cobenfy’s formulation while optimising its dosing schedule to a more convenient once-daily oral regimen, and a multi-month injectable. BMS said patients can enrol in a patient assistance scheme called the Cobenfy Cares programme in late October when the drug is set to be available.