A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Electrophysiology of ANAVEX3-71 in Adult Patients With Schizophrenia in a Multiple Ascending Dose Study (Part A), Followed by a Double-Blind, Randomized, Placebo-Controlled Study (Part B)

A study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and electrophysiology of ANAVEX3-71 in patients with Schizophrenia.

开始日期2024-03-15

申办/合作机构

Anavex Life Sciences Corp.

[+2]

NCT04442945 / Completed临床1期

A Double-blind, Randomized, Placebo-controlled, Phase 1 Safety and Tolerability, and Pharmacokinetics Study of ANAVEX3-71

A first in human phase 1 study in healthy volunteers to assess ANAVEX3-71 safety, tolerability, bioavailability, pharmacokinetics, and pharmacodynamics

开始日期2020-07-03

申办/合作机构

Anavex Life Sciences Corp.

[+1]

100 项与 ANAVEX 3-71 相关的临床结果

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100 项与 ANAVEX 3-71 相关的转化医学

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100 项与 ANAVEX 3-71 相关的专利（医药）

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项与 ANAVEX 3-71 相关的文献（医药）

2024-01-01·Clinical pharmacology in drug development

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

Article

作者: Missling, Christopher U ; Hammond, Edward ; Tran, James ; Ette, Ene ; Fadiran, Emmanuel O

Abstract:

Pharmacokinetic (PK) data from 28 subjects who received 5‐200‐mg single ascending doses of ANAVEX3‐71, formerly AF710B, were analyzed to characterize the PK of ANAVEX3‐71 and its M8 metabolite. PK data from 12 subjects who received 160 mg ANAVEX3‐71 under fed and fasted conditions were analyzed to characterize the effect of food on the PK of the drug and its M8 metabolite. PK was characterized using the standard 2‐stage approach and the nonlinear mixed‐effects modeling approach. Dose proportionality was determined using the power model. Two‐ and 3‐compartment linear PK models were tested for the characterization of the PK of ANAVEX3‐71 and its M8 metabolite. The PK of ANAVEX3‐71 is linear, dose proportional, and time invariant. The drug is rapidly eliminated with a mean (standard deviation) apparent terminal elimination half‐life of 3.56 (4.09) hours, while the M8 metabolite was eliminated with a mean (standard deviation) apparent terminal elimination half‐life of 6.59 (1.64) hours. The population PK model was used to investigate the effects of covariates on the PK of ANAVEX3‐71 and M8. Age, weight, and creatinine clearance were not explanatory of the variability in apparent clearance and apparent volume of the central compartment of ANAVEX3‐71. Food had no effect on the PK of ANAVEX3‐71 and its M8 metabolite.

2023-12-01·Neurobiology of aging

Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology

Article

作者: Bonomo, Quentin ; Do Carmo, Sonia ; Orciani, Chiara ; Lavagna, Agustina ; Foret, Morgan K ; Huang, Chunwei ; Cuello, A Claudio ; Hall, Helene

The application of the selective allosteric M1 muscarinic and sigma-1 receptor agonist, AF710B (aka ANAVEX3-71), has shown to attenuate Alzheimer's disease-like hallmarks in McGill-R-Thy1-APP transgenic rats when administered at advanced pathological stages. It remains unknown whether preventive treatment strategies applying this compound may be equally effective. We tested whether daily oral administration of AF710B (10 µg/kg) in 7-month-old, preplaque, McGill-R-Thy1-APP rats for 7 months, followed by a 4-week washout period, could prevent Alzheimer's disease-like pathological hallmarks. Long-term AF710B treatment prevented the cognitive impairment of McGill-R-Thy1-APP rats. The effect was accompanied by a reduction in the number of amyloid plaques in the hippocampus and the levels of Aβ42 and Aβ40 peptides in the cerebral cortex. AF710B treatment also reduced microglia and astrocyte recruitment toward CA1 hippocampal Aβ-burdened neurons compared to vehicle-treated McGill-R-Thy1-APP rats, also altering the inflammatory cytokines profile. Lastly, AF710B treatment rescued the conversion of brain-derived neurotrophic factor precursor to its mature and biologically active form. Overall, these results suggest preventive and disease-modifying properties of the compound.

2023-09-01·Clinical pharmacology in drug development

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.

Article

作者: Xue, Hongqi ; Kaufmann, Walter E ; Hammond, Edward ; Tran, James ; Chen, Janell ; Missling, Christopher U ; Darpo, Borje ; Fadiran, Emmanuel O

This is the cardiodynamic evaluation of a single ascending dose study in healthy participants with the primary objective of assessing the effect of ANAVEX3-71, formerly AF710B, on ECG parameters. Twelve-lead ECGs were obtained at 3 time points within 1 hour prior to dosing to establish a baseline and then serially postdose. Concentration-QTc analysis of plasma concentrations of ANAVEX3-71 and metabolite M8 was conducted. ANAVEX3-71 at the studied doses did not have a clinically relevant effect on heart rate or on the PR and QRS intervals. ANAVEX3-71 alone was retained in the primary model due to small fit differences between models which included the metabolite M8. The estimated population slope of the concentration-QTcF relationship was small and slightly negative: -0.017 ms per µg/L, with a small treatment effect-specific intercept of -0.49 ms. An effect on the placebo-corrected, change-from-baseline QTc exceeding 10 ms can be excluded within the full observed ranges of plasma concentrations of ANAVEX3-71 and M8 up to ∼996 and ∼58 µg/L, respectively. The results from this cardiodynamic evaluation demonstrated that ANAVEX3-71 at single ascending doses of 5-200 mg had no clinically relevant effects on any of the studied ECG parameters.

项与 ANAVEX 3-71 相关的新闻（医药）

2024-12-23

·GlobeNewswire-Health Care

Anavex Life Sciences Reports Fiscal 2024 Fourth Quarter Financial Results and Provides Business Update

Company to host a webcast today at 8:30 a.m. Eastern Time NEW YORK, Dec. 23, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024. “We are excited about the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing and our team remains deeply committed to executing on our momentum,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “I am proud of the strides the Anavex team has made in the recent quarter to potentially making a difference for individuals suffering from Alzheimer’s disease, by presenting a scalable treatment alternative alongside the ease of oral administration.” Recent Highlights: On December 23, 2024, Anavex announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer’s disease.On December 9, 2024, Anavex announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA.On December 2, 2024, Anavex announced its participation in a fireside chat which was held December 4th, 2024, at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL.On November 26, 2024, Anavex announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1On November 25, 2024, Anavex reported the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025.On October 31, 2024, Anavex presented new data from the Phase IIb/III study showing blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, in Madrid, Spain.On October 17, 2024, Anavex announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025. Financial Highlights: Cash and cash equivalents of $132.2 million at September 30, 2024 compared to $151.0 million at September 30, 2023. As of fiscal year end, the Company anticipates at the current cash utilization rate, a runway of approximately 4 years.General and administrative expenses for the fourth quarter of $2.8 million compared to $2.6 million for the comparable quarter of fiscal 2023.Research and development expenses for the fourth quarter of $11.6 million compared to $10.1 million for the comparable quarter of fiscal 2023.Net loss for the fourth quarter of $11.6 million, or $0.14 per share, compared to a net loss of $10.1 million, or $0.12 per share for the comparable quarter of fiscal 2023. The financial information for the fiscal year ended September 30, 2024, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com. Webcast / Conference Call Information: The live webcast of the conference call will be available on Anavex’s website at www.anavex.com. The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 814 6482 4038 and reference passcode 336064. A replay of the conference call will also be available on Anavex’s website for up to 30 days. 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, 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. 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. Anavex Life Sciences Corp.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts) Three months ended September 30, 2024 2023 Operating Expenses General and administrative$ 2,781 $ 2,592 Research and development 11,555 10,061 Total operating expenses 14,336 12,653 Operating loss (14,336) (12,653) Other income (expense) Grant income 75 - Research and development incentive income 700 670 Interest income, net 1,759 1,958 Foreign exchange gain (loss) 117 (186)Gain on write-off of accounts payable (59 ) - Total other income, net 2,592 2,442 Net loss before provision for income taxes (11,744) (10,211)Income tax recovery, current 124 64 Net loss and comprehensive loss$ (11,620)$ (10,147) Net loss per share Basic and diluted$ (0.14)$ (0.12) Weighted average number of shares outstanding Basic and diluted 84,795,517 81,973,250 Anavex Life Sciences Corp.Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share amounts) Twelve months ended September 30, 2024 2023 Operating Expenses General and administrative$ 11,039 $ 12,039 Research and development 41,838 43,717 Total operating expenses 52,877 55,756 Operating loss (52,877) (55,756) Other income (expense) Grant income 75 25 Research and development incentive income 2,291 2,718 Interest income, net 7,320 6,519 Other financing expense - (964)Foreign exchange gain (loss) 189 (40)Total other income, net 9,875 8,258 Net loss before provision for income taxes (43,002) (47,498)Income tax expense, current - (7)Net loss and comprehensive loss$ (43,002)$ (47,505) Net loss per share Basic and diluted$ (0.52)$ (0.60) Weighted average number of shares outstanding Basic and diluted 83,468,049 79,787,596 Anavex Life Sciences Corp.Consolidated Balance Sheets(in thousands, except share and per share amounts) September 30, 2024 2023 Assets Current Cash and cash equivalents$ 132,187 $ 151,024 Incentive and tax receivables 2,449 2,709 Prepaid expenses and other current assets 931 653 Total Assets$ 135,567 $ 154,386 Liabilities and stockholders' equity Current Liabilities Accounts payable$ 9,627 $ 4,322 Accrued liabilities 4,835 7,295 Deferred grant income 842 917 Total Liabilities 15,304 12,534 Capital Stock 85 82 Additional paid-in capital 456,249 434,839 Accumulated deficit (336,071) (293,069)Total Stockholders' Equity 120,263 141,852 Total Liabilities and Stockholders' Equity$ 135,567 $ 154,386 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 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

临床2期财报

2024-12-23

·anavex.com

Anavex Life Sciences Reports Fiscal 2024 Fourth Quarter Financial Results and Provides Business Update

NEW YORK – December 23, 2024 Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) diseases, today reported financial results for its fourth quarter and fiscal year ended September 30, 2024. “We are excited about the potential to advance a novel treatment for early Alzheimer’s disease with convenient oral dosing and our team remains deeply committed to executing on our momentum,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “I am proud of the strides the Anavex team has made in the recent quarter to potentially making a difference for individuals suffering from Alzheimer’s disease, by presenting a scalable treatment alternative alongside the ease of oral administration.” Recent Highlights: On December 23, 2024, Anavex announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer’s disease. On December 9, 2024, Anavex announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA. On December 2, 2024, Anavex announced its participation in a fireside chat which was held December 4th, 2024, at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL. On November 26, 2024, Anavex announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council. [1] On November 25, 2024, Anavex reported the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025. On October 31, 2024, Anavex presented new data from the Phase IIb/III study showing blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, in Madrid, Spain. On October 17, 2024, Anavex announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025. On December 23, 2024, Anavex announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for blarcamesine (ANAVEX®2-73), an investigational drug for the treatment of Alzheimer’s disease. On December 9, 2024, Anavex announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension (OLE) trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13–16, 2025, in San Francisco, CA. On December 2, 2024, Anavex announced its participation in a fireside chat which was held December 4th, 2024, at the 7th Annual Evercore ISI HealthCONx Conference 2024 in Coral Gables, FL. On November 26, 2024, Anavex announced the submission of the blarcamesine (ANAVEX®2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission is for the treatment of Alzheimer’s Disease. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council. [1] On November 25, 2024, Anavex reported the acceptance of a peer-reviewed manuscript titled “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025. On October 31, 2024, Anavex presented new data from the Phase IIb/III study showing blarcamesine (ANAVEX®2-73), once daily orally, demonstrates pre-specified clinical efficacy through upstream SIGMAR1 activation. Clinical data confirmed the mechanism of action by pre-specified SIGMAR1 gene analysis in people with early Alzheimer's disease. The data were presented by Marwan Noel Sabbagh, MD, Professor of Neurology at Barrow Neurological Institute and Chairman of the Anavex Scientific Advisory Board at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, in Madrid, Spain. On October 17, 2024, Anavex announced encouraging preliminary electroencephalography (EEG) biomarker results from Part A of the ongoing placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia. Preliminary results demonstrated a dose-dependent effect of ANAVEX®3-71 on two key EEG biomarkers in patients with schizophrenia. Anavex expects data from Part B of the placebo-controlled Phase 2 study, which includes more participants and a longer treatment duration, in the first half of 2025. Financial Highlights: Cash and cash equivalents of $132.2 million at September 30, 2024 compared to $151.0 million at September 30, 2023. As of fiscal year end, the Company anticipates at the current cash utilization rate, a runway of approximately 4 years. General and administrative expenses for the fourth quarter of $2.8 million compared to $2.6 million for the comparable quarter of fiscal 2023. Research and development expenses for the fourth quarter of $11.6 million compared to $10.1 million for the comparable quarter of fiscal 2023. Net loss for the fourth quarter of $11.6 million, or $0.14 per share, compared to a net loss of $10.1 million, or $0.12 per share for the comparable quarter of fiscal 2023. The financial information for the fiscal year ended September 30, 2024, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com. Cash and cash equivalents of $132.2 million at September 30, 2024 compared to $151.0 million at September 30, 2023. As of fiscal year end, the Company anticipates at the current cash utilization rate, a runway of approximately 4 years. General and administrative expenses for the fourth quarter of $2.8 million compared to $2.6 million for the comparable quarter of fiscal 2023. Research and development expenses for the fourth quarter of $11.6 million compared to $10.1 million for the comparable quarter of fiscal 2023. Net loss for the fourth quarter of $11.6 million, or $0.14 per share, compared to a net loss of $10.1 million, or $0.12 per share for the comparable quarter of fiscal 2023. The financial information for the fiscal year ended September 30, 2024, should be read in conjunction with the Company’s consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com. Webcast / Conference Call Information: The live webcast of the conference call will be available on Anavex’s website at www.anavex.com. The conference call can be also accessed by dialing 1 929 205 6099 for participants in the U.S. using the Meeting ID# 814 6482 4038 and reference passcode 336064. A replay of the conference call will also be available on Anavex’s website for up to 30 days. 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, 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. 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 Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com [1] https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/

临床2期临床结果财报

2024-11-27

·GlobeNewswire-Health Care

Anavex Life Sciences Announces Acceptance of Peer-Reviewed Manuscript of Oral Blarcamesine Phase IIb/III Data in a Reference Alzheimer’s Disease Journal

Nov. 25, 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 the acceptance of a peer-reviewed manuscript titled, “Blarcamesine for the treatment of Early Alzheimer’s Disease: Results from the ANAVEX2-73-AD-004 Phase IIB/III trial,” in a medical journal with focus on Alzheimer’s disease. The publication date is expected around Q4 2024/Q1 2025. “The publication in a peer-reviewed medical journal is an important milestone for the Anavex team and is a testament to the importance of the findings for the scientific and Alzheimer’s disease communities,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development of Anavex. “We are on track for regulatory submission of oral blarcamesine in Europe (EMA) in the current quarter 2024.” “We are honored to be sharing this peer-reviewed manuscript in an international journal,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide and this forthcoming publication could be helpful to educate the medical and scientific community about the potential of oral blarcamesine for patients with Alzheimer's disease.” This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval. There are an estimated 7 million people in Europe with Alzheimer’s disease, a number expected to double by 2030, according to the European Brain Council.1 The World Health Organization (WHO) estimated the cost in Europe of caring for people with dementia, including Alzheimer's disease, at $439 billion, or $31,144 per person in 2019. That includes hospital care, medicines, diagnostics, informal caregiver time, community services and long-term care facility costs.2,3 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 https://www.braincouncil.eu/projects/rethinking-alzheimers-disease/ 2 Jönsson L. The personal economic burden of dementia in Europe. Lancet Reg Health Eur. 2022 Jul 25;20:100472. doi: 10.1016/j.lanepe.2022.100472. PMID: 35910037; PMCID: PMC9326307. 3 World Health Organization (WHO); 2021. Global status report on the public health response to dementia. The content above comes from the network. if any infringement, please contact us to modify.

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适应症	最高研发状态	国家/地区	公司	日期
精神分裂症	临床2期	美国	Anavex Life Sciences Corp.	2024-03-15
额颞痴呆	临床1期	澳大利亚	Anavex Life Sciences Corp.	2020-07-03
阿尔茨海默症	临床1期	-	Anavex Life Sciences Corp.	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06245213 (ANAVEX®3-71-SZ-001, GlobeNewswire) 人工标引	临床2期	精神分裂症	16	ANAVEX®3-71 (Part A)	襯遞齋鹹顧膚簾範獵襯(觸選鹹選製膚觸鹹餘製) = 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. 衊選網艱夢憲製觸鏇觸 (築鑰範觸艱廠淵糧簾鑰 ) 更多	积极	2024-10-17
				Placebo (Part A)