Alzheimer Disease, Familial, 1

POTOMAC, Md.--(BUSINESS WIRE)-- IGC Pharma, Inc. (“IGC Pharma”, “IGC”, or the “Company”) (NYSE American: IGC) today announced that Ram Mukunda, CEO, and Claudia Grimaldi, Vice President, will participate in a fire chat at the BENZINGA VIRTUAL HEALTHCARE SUMMIT 2024 ( ). Benzinga virtual healthcare summit 2024 will be held on March 20, 2024. IGC Pharma is scheduled at 12:30 PM EDT. To register for the event please see: Benzinga recently published an article entitled: “IGC Pharma advances in Alzheimer’s research from pre-clinical studies to phase two trial with its novel therapy candidate IGC-AD1.” For the full article please refer to: About IGC Pharma Inc. (IGC): IGC Pharma Inc. (“IGC”) is focused on Alzheimer's disease, developing innovative solutions to address this devastating illness. The Company's mission is to transform the landscape of Alzheimer's treatment with a robust pipeline of five promising drug candidates. IGC-AD1 and LMP target the hallmarks of Alzheimer's disease, including neuroinflammation, Aβ plaques, and neurofibrillary tangles. IGC-AD1 is currently undergoing a Phase 2 clinical trial for agitation in dementia associated with Alzheimer's (clinicaltrials.gov, CT05543681). TGR-63 disrupts the progression of Alzheimer's by targeting Aβ plaques. IGC-M3, currently in preclinical development, aims to inhibit the aggregation of Aβ plaques, potentially impacting early-stage Alzheimer's. IGC-1C, also in preclinical stages, targets tau protein and neurofibrillary tangles, representing a forward-thinking approach to Alzheimer's therapy. In addition to its drug development pipeline, IGC Pharma is seeking to leverage Artificial Intelligence (“AI”) for Alzheimer's research. Their AI projects encompass various areas, including clinical trial optimization and early detection of Alzheimer's. Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based largely on IGC Pharma’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC Pharma’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required, or government regulations affecting AI or the AI algorithms not working as intended or producing accurate predictions; general economic conditions that are less favorable than expected; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC Pharma’s U.S. Securities and Exchange Commission ("SEC") filings. IGC Pharma incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on July 7, 2023, and Quarterly Report on Form 10-Q filed with the SEC on February 14, 2024, as if fully incorporated and restated herein. Considering these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

TOKYO, March 5, 2024 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that its U.S. subsidiary Eisai Inc. has decided to invest up to 15 million USD in C2N Diagnostics LLC (Headquarters: St. Louis, Missouri, the United States "C2N") to support C2N's efforts to expand the availability, accessibility, affordability and utilization of blood-based tests for the diagnosis of Alzheimer's disease (AD) in the U.S. This investment is in addition to the collaboration with C2N announced in August 2022 regarding the use of blood-based assays in the diagnosis of people living with dementia in clinical practice in the U.S. The presence of amyloid β (Aβ), a component of AD pathology, is currently confirmed using advanced diagnostic techniques such as positron emission tomography (PET) or by tests that require the collection of cerebrospinal fluid (CSF). By investing in C2N, Eisai seeks to support efforts to advance blood-based Aβ diagnostics that are accurate and affordable, providing new options for confirming the presence of Aβ. "The field of highly accurate blood-based diagnostics is rapidly advancing and expanding," said Keisuke Naito, Global Alzheimer's Disease Officer, Senior Vice President, Eisai. "Given the expense and capacity limitations of PET and CSF tests, Eisai is working to support the dementia ecosystem's growth. The availability of more affordable and minimally invasive diagnostic tools helps support broad access for the management of Alzheimer's disease." An estimated 6.7 million people in the U.S. are living with Alzheimer's dementia.1 Clinical symptoms alone cannot provide accurate diagnosis. Identifying patients through accurate and simple blood-based testing may lead to more efficient diagnoses, expanded treatment opportunities and reduced medical and care costs, thereby simplifying and accelerating earlier treatment, when appropriate. Importantly, blood-based tests could also support improved care for people in underserved communities and areas where access to amyloid PET and CSF testing are not a viable option. As a pioneer in the AD field and an hhceco company, Eisai is strongly committed to supporting the development of an environment that includes the blood-based diagnosis of AD. Using multiple approaches, Eisai collaborates with several diagnostic companies and with local governments to expand the dementia ecosystem. This investment and Eisai's collaboration with C2N are examples of such activities, through which we seek to provide and support solutions that can help relieve the anxieties of people living with AD, their families and care partners. [Notes to editors] About C ₂ N Diagnostics, LLC C2N Diagnostics ("C2N") is a specialty diagnostics company with a vision to bring Clarity Through Innovation®. C2N strives to provide exceptional clinical laboratory services and advanced diagnostic solutions in the field of brain health. C2N's high-resolution mass spectrometry-based biomarker services and products are used for: clinical decision-making to improve patient care, including diagnosis and treatment monitoring; maximizing the quality and efficiency of clinical trials that test novel treatments for neurodegeneration; and providing innovative tools to help healthcare researchers better understand novel mechanisms of disease, identify new treatment targets, and conduct important epidemiologic studies to improve global public health. C2N assays have been used in over 150 Alzheimer's disease and other research studies throughout the U.S. and the world. This includes landmark treatment and prevention trials involving disease-modifying therapies (DMTs) that are changing the trajectory of Alzheimer's disease. C2N has ongoing collaborations with multi-national pharmaceutical and biotech companies, leading academic institutions, National Institute on Aging, Alzheimer's Association, and other non-profits and consortiums. Over 15,000 Precivity™-related biomarker measures have been reported through peer-reviewed publications, with many more manuscripts currently under review. For more information visit . SOURCE Eisai Inc.

NEW YORK, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, today announced a peer-reviewed publication in Clinical Pharmacology in Drug Development, findings from the ANAVEX®3-71 first-in-human study which achieved its safety objectives. The publication is entitled, ‘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’.1 The publication reports the Population-based characterization of the Pharmacokinetics (PK) and food effect of ANAVEX®3-71 as part of the single ascending dose study in healthy participants with the primary objective of assessing dose proportionality of ANAVEX®3-71, and to characterize the effect of food on the PK of ANAVEX®3-71. The results from this PK evaluation demonstrated that ANAVEX®3-71, at single ascending doses of 5 to 200 mg, is linear, dose proportional, and time invariant. Food had no effect on the PK of ANAVEX®3-71. This data also expands the safety objectives met in this first-in-human study of ANAVEX®3-71, further supporting its drug development program. While KarXT from Karuna Therapeutics (KRTX), a muscarinic M1 receptor agonist, demonstrated weak benefits on cognitive impairments in individuals with Schizophrenia,2 ANAVEX®3-71’s dual-pharmacological action on SIGMAR1 and M1 muscarinic receptors is implicated in its pro-cognitive effects in murine Alzheimer’s disease models and demonstrates its potential to treat cognitive and behavioral deficits in neurological diseases by affecting protein homeostasis in the central nervous system.3,4,5 “This published clinical study demonstrates Anavex’s commitment to advance Anavex’s clinical pipeline including ANAVEX®3-71 for Schizophrenia, Frontotemporal Dementia, and Alzheimer's Disease,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. "We are looking forward to reporting first patient dosed in the upcoming U.S. Phase 2 clinical trial in Schizophrenia with ANAVEX®3-71.” The paper can be accessed online at: https://pubmed.ncbi.nlm.nih.gov/38073274/. About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia 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 recently 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 with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores 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. 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. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor RelationsTel: 516-662-9461Email: andrew@barwicki.com 1 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.13232 Sauder C, Allen LA, Baker E, Miller AC, Paul SM, Brannan SK. Effectiveness of KarXT (xanomeline-trospium) for cognitive impairment in schizophrenia: post hoc analyses from a randomised, double-blind, placebo-controlled phase 2 study. Transl Psychiatry. 2022;12(1):491. Published 2022 Nov 21. doi:10.1038/s41398-022-02254-93 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:10.1159/0004408644 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.2017.11.0095 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. Neurobiol Aging. 2023;132:220-232. doi:10.1016/j.neurobiolaging.2023.09.010