Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming Pharmacokinetic Dose Proportionality of ANAVEX®3-71 in Humans
Anavex Life Sciences Corp. announced the findings from the ANAVEX®3-71 first-in-human study, which achieved its safety objectives. The study demonstrated that ANAVEX®3-71 is linear, dose proportional, and time invariant at single ascending doses of 5 to 200 mg, with no effect from food. The publication further supports ANAVEX®3-71's drug development program, showcasing its potential to treat cognitive and behavioral deficits in neurological diseases.
Positive
ANAVEX®3-71 achieved its safety objectives in the first-in-human study
The drug is linear, dose proportional, and time invariant at single ascending doses of 5 to 200 mg
Food had no effect on the pharmacokinetics of ANAVEX®3-71
The drug has potential to treat cognitive and behavioral deficits in neurological diseases
The findings from Anavex Life Sciences Corp. concerning ANAVEX®3-71 are pivotal within the pharmaceutical industry, particularly in the realm of neurodegenerative and neurodevelopmental disorders treatment. The drug's successful safety profile in early-stage clinical trials is a crucial step in drug development, as safety concerns are a common reason for the discontinuation of clinical programs. The report of linear, dose-proportional and time-invariant pharmacokinetics suggests a predictable and manageable dosing regimen for future clinical trials, which is a positive indicator for both clinicians and investors.
Moreover, the lack of a food effect on the pharmacokinetics of ANAVEX®3-71 simplifies its administration and could improve patient compliance in real-world settings. This aspect is particularly noteworthy when compared to other treatments that may require fasting or have dietary restrictions. The dual-pharmacological action of the drug, targeting both SIGMAR1 and M1 muscarinic receptors, presents a novel approach that could potentially offer therapeutic advantages over competitors like KarXT from Karuna Therapeutics, which targets only the M1 receptor and has shown weaker cognitive benefits.
The announcement by Anavex Life Sciences Corp. has the potential to significantly influence investor sentiment and the company's stock market performance. Positive early-stage clinical results often lead to increased investor confidence, which can translate into stock price appreciation. The development of ANAVEX®3-71, particularly for high-need indications such as Alzheimer’s disease, Frontotemporal Dementia and Schizophrenia, addresses substantial markets with a significant unmet medical need, potentially leading to a lucrative revenue stream upon successful development and commercialization.
Investors should note, however, that the drug is still in the early phases of clinical development and the path to market approval is long and fraught with potential setbacks. Nonetheless, the specificity of ANAVEX®3-71's pharmacological action and its safety profile could attract partnership opportunities, licensing deals, or even acquisition interest from larger pharmaceutical companies looking to enhance their neurology portfolios.
In the context of the broader pharmaceutical market, the progress of ANAVEX®3-71 is indicative of the growing focus on precision medicine approaches in treating CNS disorders. The differentiation of Anavex's compound through its dual mechanism of action could position the company as a leader in a niche but growing segment of the neurology market. It is essential to understand the competitive landscape, where drugs that demonstrate efficacy and safety in complex CNS disorders can command high prices and market exclusivity, especially in the United States.
From a market perspective, the successful development of ANAVEX®3-71 could disrupt current treatment paradigms and provide a competitive alternative to existing therapies. The company's strategic focus on a diverse range of CNS disorders also mitigates the risk of clinical trial failure in any single indication, potentially providing multiple avenues for market penetration and revenue diversification.
01/24/2024 - 07:30 AM
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 Twitter Facebook Instagram 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: info@anavex.com
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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
What are the findings from the ANAVEX®3-71 first-in-human study?
The study demonstrated that ANAVEX®3-71 is linear, dose proportional, and time invariant at single ascending doses of 5 to 200 mg, with no effect from food.
What is the potential of ANAVEX®3-71 in treating neurological diseases?
The drug has the potential to treat cognitive and behavioral deficits in neurological diseases.
Who is the President and CEO of Anavex Life Sciences Corp.?
Christopher U Missling, PhD, is the President and Chief Executive Officer of Anavex.
