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Anavex Life Sciences Reports Publication of ANAVEX 3-71 in Clinical Journal Confirming ANAVEX 3-71 Clinical Cardiovascular Safety

Key Takeaway: Anavex Life Sciences Corp. reported the publication of findings from the ANAVEX®3-71 first-in-human study in Clinical Pharmacology in Drug Development, confirming the drug's cardiovascular safety. The study evaluated the drug's effects on ECG parameters and found no clinically relevant issues at doses ranging from 5 to 200 mg. This data broadens the safety assurance for ANAVEX®3-71 and supports Anavex's ongoing drug development efforts. Looking ahead, Anavex is set to begin Phase 2 clinical trials for Schizophrenia later this year.

Market Sentiment Analysis

POSITIVE FACTORS

  • ANAVEX®3-71 confirmed no clinically relevant effects on ECG parameters.
  • Positive published results support Anavex's drug development program.
  • The company plans to initiate Phase 2 clinical trials for Schizophrenia.

Full Press Release Details

NEW YORK, Aug. 07, 2023 (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 cardiovascular safety objectives. The publication is entitled, ‘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’. 1
The publication reports the cardiodynamic evaluation part of the single ascending dose study in healthy participants with the primary objective of assessing the effect of ANAVEX®3-71 on ECG (electrocardiogram) parameters.
The results from this cardiodynamic evaluation demonstrated that ANAVEX®3-71 at single ascending doses of 5 to 200 mg had no clinically relevant effects on any of the studied ECG parameters and hence confirmed the ANAVEX®3-71 preclinical cardiovascular safety findings. These data also expand the safety objectives met in this first-in-human study of ANAVEX®3-71, further supporting its drug development program.
“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 initiating the Phase 2 clinical trial in Schizophrenia with ANAVEX®3-71 in the second half of 2023.”
The paper can be accessed online at: https://pubmed.ncbi.nlm.nih.gov/37515316/.
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, 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 sigma-1 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 sigma-1 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
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1 Fadiran EO, Hammond E, Tran J, Xue H, Chen J, Kaufmann WE, Missling CU, Darpo B. 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 Jul 28. doi: 10.1002/cpdd.1303. Epub ahead of print. PMID: 37515316.

Frequently Asked Questions

What is ANAVEX®3-71 developed for?

ANAVEX®3-71 is in development for treating Frontotemporal Dementia, Schizophrenia, and Alzheimer's Disease.

What were the safety findings of ANAVEX®3-71?

The cardiovascular safety study showed ANAVEX®3-71 had no clinically relevant effects on ECG parameters.

When will the Phase 2 trial for ANAVEX®3-71 begin?

The Phase 2 clinical trial for Schizophrenia with ANAVEX®3-71 is set to start in late 2023.

How does Anavex support drug development?

Anavex commits to advancing its clinical pipeline, including significant studies on ANAVEX®3-71.

What disorders does Anavex target?

Anavex targets neurodegenerative and neurodevelopmental disorders, including Alzheimer's and Parkinson's.

Last updated: Aug 7, 2023