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ANAVEX LIFE SCIENCES CORP.

(AVXL)
  Report
Delayed Nasdaq  -  04:00:00 2023-01-27 pm EST
10.56 USD   +0.38%
01/12Transcript : Anavex Life Sciences Corp. Presents at 41st Annual J.P. Morgan Healthcare Conference, Jan-12-2023 08:15 AM
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ANAVEX«2–73 (Blarcamesine) Phase 2B/3 Study Met Primary and Key Secondary Endpoints, Showing Statistically Significant Reduction of Clinical Decline in Global Clinical Study of Patients With Early Alzheimer’s Disease

12/01/2022 | 08:26pm EST

Anavex Life Sciences Corp. announced positive topline results from its Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial of oral ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD). ANAVEX®2-73 met the primary endpoints ADAS-Cog and ADCS-ADL and key secondary endpoint CDR-SB with statistically significant results.

Next step, in light of this data, is meeting with regulatory authorities to discuss this data in the context of ongoing development with an aim to bring this therapy to patients in Europe, Asia-Pacific, and the U.S. ANAVEX®2-73 (blarcamesine) is an orally available, small-molecule activator of the sigma-1 receptor (SIGMAR1), which, data suggest, is pivotal to restoring neural cell homeostasis and promoting neuroplasticity. ANAVEX®2-73-AD-004 was a randomized, double-blind, multicenter, placebo-controlled 509 patient Phase 2b/3 study (randomized 1:1:1 to mid or high dose of ANAVEX®2-73 or placebo), for the treatment of early Alzheimer's disease over 48 weeks. Top line data will be presented later in the late breaking oral communication presentation at the Clinical Trials on Alzheimer's Disease (CTAD) Congress 2022, December 1, 2022, at 4:30pm PT in San Francisco, CA.

Further analysis of the data remains ongoing, and the Company plans to submit the data for publication in a peer-reviewed medical journal. The open-label extension study ATTENTION-AD will continue to follow participants over a 96 week period. ANAVEX®2-73 treatment met the primary endpoints and reduced clinical decline on the global cognitive and functional scales over 48 weeks in the analysis of the Intent-to-treat (ITT) population.

ANAVEX®2-73 demonstrated visible improvement in patients with Alzheimer's disease. Patients treated with ANAVEX®2-73 were 84% more likely, to have improved cognition by ADAS-Cog score change of -0.50 points or better from baseline to end of treatment than patients on placebo, Odds Ratio = 1.84 (p = 0.015). On average, patients, who improved cognitively with ANAVEX®2-73 treatment, improved by ADAS-Cog cognition score of -4.03 points.

ANAVEX®2-73 treatment was 167% more likely to improve function compared with placebo, at a clinically meaningful improvement of ADCS-ADL score change of +3.5 points or better, Odds Ratio = 2.67 (p=0.0255). This reflects a robust improved and clinically meaningful outcome in cognition and function from baseline. Additionally, treatment with ANAVEX®2-73 statistically significantly reduced cognitive decline, measured with ADAS-Cog, compared to placebo at end of treatment by 45%, representing a treatment difference in mean score change of -1.85 points (p=0.033).

ANAVEX®2-73 treatment also met the secondary endpoint of reduction in clinical decline of cognition and function assessed by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) compared to placebo, by a treatment difference in mean score change of -0.42 points (p=0.040), representing 27% reduction in the ITT population. ANAVEX®2-73 (blarcamesine) was generally safe and well tolerated. The incidence of treatment emergent adverse events (TEAEs) was similar in the active and placebo arms with dizziness being the most common TEAE.

TEAEs =7.5% threshold were predominantly mild or moderate. No clinically significant changes in vital signs, laboratory values and ECG parameters in active and placebo arms were observed. Safety findings in the study were consistent with the known safety profile of ANAVEX®2-73.

In addition to safety and efficacy demonstrated on the primary and key secondary endpoints, a pre-specified analysis of patients without SIGMAR1 gene mutation provides further confidence of the robustness of the SIGMAR1 activation in the treatment of neurodegenerative diseases. Approximately 80% of the total worldwide population lack a SIGMAR1 gene mutation. ANAVEX®2-73 was more efficacious in this pre-specified population.

This effect is consistent with prior clinical trials of ANAVEX®2-73.6.


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Financials (USD)
Sales 2023 1,67 M - -
Net income 2023 -58,5 M - -
Net Debt 2023 - - -
P/E ratio 2023 -14,7x
Yield 2023 -
Capitalization 823 M 823 M -
Capi. / Sales 2023 492x
Capi. / Sales 2024 18,2x
Nbr of Employees 38
Free-Float 97,0%
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Number of Analysts 3
Last Close Price 10,56 $
Average target price 41,67 $
Spread / Average Target 295%
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Managers and Directors
Christopher U. Missling Chairman, President, CEO & Secretary
Sandra Boenisch Chief Financial Officer & Treasurer
Walter E. Kaufmann Chief Scientific Officer
Edward R. Hammond Chief Medical Officer
Stephan Toutain Chief Operating Officer
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