Proof of Concept Controlled Phase 2 Clinical Trial Data Evaluating ANAVEX®2-73 (blarcamesine) in Parkinson’s Disease Dementia Presented at CTAD 2020 Conference

Rhea-AI Summary

Anavex Life Sciences Corp. (Nasdaq: AVXL) recently presented findings from a Phase 2 clinical trial of ANAVEX®2-73 (blarcamesine) at the CTAD conference. The study involved 132 patients with Parkinson's disease dementia (PDD) and demonstrated statistically significant improvements in cognitive functions, specifically in Attention (p = 0.039) and Episodic Memory (p = 0.003). ANAVEX®2-73 was well tolerated, showing a favorable safety profile compared to typical dementia drugs. The company plans to submit results for publication and seek FDA guidance for a pivotal trial in PDD.

Positive

• Statistically significant improvements in cognitive functions: Attention (p = 0.039), Digital Vigilance (p = 0.008), and Episodic Memory (p = 0.003).
• ANAVEX®2-73 was well tolerated at doses up to 50 mg.
• The study supports the precision medicine approach targeting SIGMAR1 as a genetic biomarker.
• The company plans a pivotal trial for ANAVEX®2-73 in Parkinson's disease dementia.

Negative

• None.

Statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008)

Statistically significant dose-dependent improvements in Episodic Memory (p = 0.003)

ANAVEX^®2-73 (blarcamesine) prevented the on-going cognitive decline in treated patients compared to placebo

Late breaking abstract of cognitive outcome measures relevant to Alzheimer’s disease selected for oral presentation at CTAD

NEW YORK, Nov. 06, 2020 (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 (AD), Parkinson’s disease (PD), Rett syndrome and other central nervous system (CNS) diseases, today announced additional details on and presented the results from the proof of concept Phase 2 controlled trial evaluating the safety, tolerability, and efficacy of ANAVEX^®2-73 (blarcamesine) in patients with Parkinson’s disease dementia (PDD) at the 13^th international conference on Clinical Trials on Alzheimer’s Disease (CTAD). CTAD is an annual conference focused on Alzheimer’s research and development and takes place this year as a virtual event on November 4-7^th, 2020.

Details of the Late-breaking Presentation:
Title: “ANAVEX^®2-73 (blarcamesine) Currently in Phase 2b/3 Early Alzheimer’s Disease (AD): Analysis of Cognitive Outcome Measures Relevant to AD of Double-blind, Multicenter, Placebo-controlled Phase 2 Clinical Trial in 132 Patients with Parkinson’s Disease Dementia”

Presentation Type:	Late-Breaking, Oral Presentation (LB25)
Presenter:	Dag Aarsland, MD, PhD - King’s College London, UK
Date/Time:	November 6, 2020, 10:45 am EST

The study found that ANAVEX^®2-73 (blarcamesine) was well tolerated in oral doses up to 50 mg once daily. The results showed clinically meaningful, dose-dependent, and statistically significant improvements in the Cognitive Drug Research (CDR) computerized assessment system analysis. The study validated the precision medicine approach of targeting SIGMAR1 as a genetic biomarker of response to ANAVEX^®2-73 (blarcamesine), confirming that ANAVEX^®2-73 (blarcamesine) acts through SIGMAR1 activation. These results support continued development in PDD / PD as well as the currently ongoing Phase 2 and Phase 2/3 clinical studies with ANAVEX^®2-73 (blarcamesine) in Rett syndrome¹ and Alzheimer’s disease².

Highlights of the study results:

• Broad and statistically significant improvements in CDR system Cognitive Domain of Attention assessed by Choice Reaction Time (p = 0.039) and Digital Vigilance (p = 0.008) and CDR system Episodic Memory (p = 0.047), representing complex cognitive tasks with impact on quality of life such as making a choice between similar objects and remembering daily personal experiences, which are mostly impaired in both PD and AD.³
• Statistically significant dose-dependent (p = 0.003) improvement of Episodic Memory, which has been shown to be highly correlated (70%) with the Alzheimer’s Disease Assessment Scale–Cognitive score (ADAS-Cog; r = 0.7).⁴
• ANAVEX^®2-73 (blarcamesine) does not impair sleep and has a positive effect on REM sleep behavior disorder.
• ANAVEX^®2-73 (blarcamesine) was generally safe, well tolerated, and improved safety profile compared to dementia drugs associated with typical adverse effects.

The presentation is available on the Anavex website (www.anavex.com).

The ANAVEX^®2-73-PDD-001 study was an international, double-blind, multicenter, placebo-controlled proof of concept Phase 2 clinical study that randomized 132 patients with PDD equally to target doses of 30mg, 50mg ANAVEX^®2-73 (blarcamesine) or placebo, respectively. In addition to safety and cognitive efficacy, sleep function was assessed during the study at week 8 and week 14.

ANAVEX^®2-73-PDD-001 study results will be submitted for publication in a peer-reviewed medical journal. Anavex is planning a pivotal trial of ANAVEX^®2-73 (blarcamesine) in Parkinson’s disease dementia after submitting the results of the study to the FDA to obtain regulatory guidance.

“I am very intrigued to see the promising results of the ANAVEX^®2-73-PDD-001 trial, providing significant improvements in cognitive function accompanied by a favorable safety and tolerability profile,” said Dag Aarsland, MD, PhD, Professor and the Head of Department of Old Age Psychiatry at the Institute of Psychiatry, Psychology & Neuroscience, King’s College London, UK. “The ANAVEX^®2-73 (blarcamesine) study results represent a meaningful step forward toward urgently needed treatment for this serious complication of Parkinson’s disease given that cognitive impairment of patients with Parkinson’s disease dementia is very distressing to patients and their families and is associated with greater risk of institutionalization and accelerated progression to severe dementia and death.”

Dr. Jaime Kulisevsky, MD, PhD, Full Professor of Neurology & Vice-Dean Faculty of Medicine Autonomous University of Barcelona and Director of the Movement Disorde

FAQ

What were the results of the ANAVEX®2-73 Phase 2 trial for Parkinson's disease dementia?

The trial showed statistically significant improvements in cognitive functions such as Attention and Episodic Memory, validating the efficacy of ANAVEX®2-73.

What is ANAVEX®2-73's role in treating Alzheimer's and Parkinson's diseases?

ANAVEX®2-73 is being developed as a treatment for cognitive decline associated with Alzheimer's and Parkinson's diseases, demonstrating promising results in clinical trials.

When was the ANAVEX®2-73 trial presented?

The findings were presented on November 6, 2020, during the CTAD conference.

What are the next steps for Anavex Life Sciences regarding ANAVEX®2-73?

Anavex plans to submit the trial results for publication and seek regulatory guidance from the FDA for a pivotal trial in Parkinson's disease dementia.

How many patients participated in the ANAVEX®2-73 trial?

The trial included 132 patients with Parkinson's disease dementia.