SIGMAR1

Anavex Life Sciences Initiates Placebo-Controlled U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

Retrieved on: 
Monday, March 18, 2024
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NEW YORK, March 18, 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, neurodevelopmental, and psychiatric disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, schizophrenia, and other central nervous system (CNS) diseases, today announced that the first patient in its U.S. FDA cleared placebo-controlled Phase 2 clinical study of ANAVEX®3-71 for the treatment of schizophrenia has been screened ahead of schedule.

Key Points: 
  • “Initiating our Phase 2 trial of ANAVEX®3-71 in schizophrenia ahead of schedule is a testament to the hard work and dedication of our clinical study team,” stated Christopher U Missling, PhD, President and Chief Executive Officer of Anavex.
  • “Schizophrenia is a challenging disorder that can impair social and occupational functions and overall quality of life for the nearly 24 million people affected worldwide.
  • The placebo-controlled Phase 2, two-part, in-patient trial, ANAVEX®3-71-SZ-001 ( NCT06245213 ), will investigate the effects of ANAVEX®3-71 in patients with schizophrenia.
  • In addition to the electrophysiological biomarkers, Anavex is applying novel neuroinflammatory, metabolomic, and transcriptomic biomarkers at the intersection of schizophrenia pathophysiology and ANAVEX®3-71’s novel, dual mechanism of action.

Anavex Life Sciences Reports Publication of ANAVEX®3-71 in Clinical Journal Confirming Pharmacokinetic Dose Proportionality of ANAVEX®3-71 in Humans

Retrieved on: 
Wednesday, January 24, 2024
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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.

Key Points: 
  • 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.
  • Phase 2 clinical trial in Schizophrenia with ANAVEX®3-71.”
    The paper can be accessed online at: https://pubmed.ncbi.nlm.nih.gov/38073274/ .

Anavex Life Sciences Announces U.S. Phase 2 Clinical Trial of ANAVEX®3-71 in Schizophrenia

Retrieved on: 
Tuesday, January 16, 2024
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NEW YORK, Jan. 16, 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 schizophrenia, today announced the initiation of the U.S. FDA cleared placebo-controlled Phase 2 trial of ANAVEX®3-71 for the treatment of schizophrenia, which is expected to begin in Q2 2024. ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1

Key Points: 
  • ANAVEX®3-71 positive initial Phase 1 results in healthy volunteers were previously reported.1
    ANAVEX®3-71 (formerly AF710B) is a dual SIGMAR1 receptor agonist and M1 positive allosteric modulator with agonistic effects.
  • As currently approved treatments only control a subset of symptoms, patients continue to exhibit severe impairments in social and occupational functioning and poor quality of life.
  • The placebo-controlled Phase 2 ANAVEX®3-71-SZ-001 study, will consist of two-parts to explore multiple ascending doses in individuals with schizophrenia followed by a 28-day treatment period in a larger cohort.
  • While current antipsychotic therapies can be effective in managing positive symptoms, like hallucinations and delusions, they may not fully address persistent negative symptoms or cognitive difficulties.

Anavex Life Sciences Reports New Publication in Scientific Journal Demonstrating the Potential of ANAVEX®3-71 to Prevent Cognitive Decline in Alzheimer’s Disease

Retrieved on: 
Wednesday, October 25, 2023
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NEW YORK, Oct. 25, 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) diseases, today reported a new peer-reviewed publication in the journal Neurobiology of Aging, titled “Early treatment with an M1 and sigma-1 receptor agonist prevents cognitive decline in a transgenic rat model displaying Alzheimer-like amyloid pathology”, featuring the orally available small molecule ANAVEX®3-71 (AF710B).1

Key Points: 
  • Preventative treatment with ANAVEX®3-71 reduced levels of insoluble and soluble amyloid-beta as well as plaque deposition in the aging cortex and hippocampus, areas heavily impacted by AD.
  • Notably, the reduction in amyloid pathology was accompanied by a reduction in inflammatory glial activity which is connected to the disease cascade in AD and other dementias.
  • ANAVEX®3-71 treatment downregulated the proinflammatory IL-1β and IL-6 cytokines, which are known to be associated with AD.
  • This long-lasting effect was also observed in previous animal studies of ANAVEX®3-71 at advanced stages of the disease.

Anavex Life Sciences Reports Fiscal 2023 Third Quarter Financial Results

Retrieved on: 
Tuesday, August 8, 2023
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NEW YORK, Aug. 08, 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) diseases, today reported financial results for its fiscal quarter ended June 30, 2023.

Key Points: 
  • Company expects to announce topline results from this study in the second half of 2023.
  • Alzheimer’s disease: Full data ANAVEX®2-73-AD-004, including newly available preliminary results of surrogate biomarkers of pivotal Phase 2b/3 clinical trial.
  • General and administrative expenses for the quarter of $3.2 million compared to $3.2 million for the comparable quarter of fiscal 2022.
  • Research and development expenses for the quarter of $10.3 million compared to $9.3 million for the comparable quarter of fiscal 2022.

Long-term Clinical Study Demonstrates Disease Modifying Effects of ANAVEX®2-73 (blarcamesine) for Rett Syndrome

Retrieved on: 
Wednesday, June 28, 2023
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The effect of ANAVEX®2-73 (blarcamesine) in the double-blind part of the U.S. ANAVEX®2-73-RS-001 study was maintained in the open label 12-week extension study.

Key Points: 
  • The effect of ANAVEX®2-73 (blarcamesine) in the double-blind part of the U.S. ANAVEX®2-73-RS-001 study was maintained in the open label 12-week extension study.
  • Meaning that ANAVEX®2-73 (blarcamesine) exhibited both symptomatic and disease modifying effects in the treatment of Rett syndrome in a clinical setting.
  • Additionally, disease progression, which is defined as change in Rett syndrome disease severity with time, was also reduced with long-term treatment with ANAVEX®2-73 (blarcamesine).
  • We are looking forward to the upcoming read-out of the ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett syndrome clinical trial in pediatric patients with Rett syndrome.”

Anavex Life Sciences Announces Completion of ANAVEX(®)2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

Retrieved on: 
Tuesday, June 6, 2023
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The Company expects to announce topline results from this study in the second half of this year.

Key Points: 
  • The Company expects to announce topline results from this study in the second half of this year.
  • The multi-center, double-blind clinical EXCELLENCE study (ANAVEX®2-73-RS-003)4 in pediatric patients is measuring safety, tolerability, and efficacy of daily oral ANAVEX®2-73 (blarcamesine) doses or placebo.
  • In communication with the FDA, the Company received the Agency’s input on the study endpoints, which were utilized in this clinical study.
  • ANAVEX®2-73 (blarcamesine) had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.

Anavex Life Sciences Reports Fiscal 2023 Second Quarter Financial Results

Retrieved on: 
Tuesday, May 9, 2023
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NEW YORK, May 09, 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) diseases, today reported financial results for its fiscal quarter ended March 31, 2023.

Key Points: 
  • Company expects to announce topline results from this study in the second half of 2023.
  • General and administrative expenses for the quarter of $2.9 million compared to $2.9 million for the comparable quarter of fiscal 2022.
  • Research and development expenses for the quarter of $11.3 million compared to $8.6 million for the comparable quarter of fiscal 2022.
  • The financial information for the quarter ended March 31, 2023, should be read in conjunction with the Company’s interim condensed consolidated financial statements, which will appear on EDGAR, www.sec.gov and will be available on the Anavex website at www.anavex.com .

Anavex Life Sciences Reports Fiscal 2023 First Quarter Financial Results

Retrieved on: 
Tuesday, February 7, 2023
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NEW YORK, Feb. 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) diseases, today reported financial results for its fiscal quarter ended December 31, 2022.

Key Points: 
  • Company expects to announce topline results from this study in the second half of 2023.
  • On January 12th, 2023, Anavex presented at the 41st Annual J.P. Morgan Healthcare Conference, in San Francisco, CA.
  • General and administrative expenses for the quarter of $3.3 million compared to $3.1 million for the comparable quarter of fiscal 2022.
  • Research and development expenses for the quarter of $12.1 million compared to $8.7 million for the comparable quarter of fiscal 2022.

Anavex Life Sciences Announces Exceeding of Enrollment Target for the ANAVEX®2-73 (blarcamesine) EXCELLENCE Phase 2/3 Rett Syndrome Clinical Trial

Retrieved on: 
Thursday, February 2, 2023
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This exceeds the original enrollment target and the Company expects to announce topline results from this study in 2H 2023.

Key Points: 
  • This exceeds the original enrollment target and the Company expects to announce topline results from this study in 2H 2023.
  • The multi-center, double-blind clinical EXCELLENCE study (ANAVEX®2-73-RS-003)4 in pediatric patients is measuring safety, tolerability, and efficacy of daily oral ANAVEX®2-73 doses or placebo.
  • ANAVEX®2-73 (blarcamesine) had previously received Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation from the FDA for the treatment of Rett syndrome.
  • “We are excited to complete enrollment in this multicenter study with ANAVEX®2-73 in Rett syndrome and look forward to reporting the results later this year.”