ANAVEX2-73

[NHE]

Anavex Life Sciences Announces Oral Blarcamesine Cognitive Resilience Results Approximating Normal Aging in New Precision Medicine Clinical Data from Phase IIb/III Alzheimer’s Disease Trial

September 9, 2025

https://www.globenewswire.com/news-rele ... -Dise.html

• New clinical Precision Medicine population 48-week data demonstrates unprecedented cognitive stabilization in early Alzheimer’s disease

• Cognitive outcomes observed in the oral blarcamesine 30 mg Precision Medicine cohort move toward normal aging profiles across validated clinical scales, supporting its relevance in early-stage Alzheimer’s care

• 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the primary cognitive endpoint ADAS-Cog13

• Blarcamesine could represent a novel treatment option for up to ~70% of early Alzheimer’s patients benefiting from further improved outcomes using directed Precision Medicine to alleviate significant medical and economic burden

NEW YORK, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, announced today the latest findings for blarcamesine, an oral small molecule for the potential treatment of early Alzheimer’s disease (AD).

On all standard scales for measuring Alzheimer’s disease and cognitive decline, after 48 weeks, the defined Precision Medicine population ABCLEAR31 consisting of early AD patients with confirmed and progressed pathology taking 30 mg once-daily oral blarcamesine demonstrated barely detectable decline. This was comparable to minimally perceptible decline in prodromal (pre-dementia) aging adults.

• For ADAS-Cog13 (the standardized neuropsychological test used in Alzheimer's disease research to measure cognitive function and track disease progression), blarcamesine showed a 48-week change from baseline of 0.853 compared to ~1 point typical annual decline in prodromal (pre-dementia) aging adults.

• For CDR-SB (Clinical Dementia Rating, standard test that evaluates the severity of cognitive impairment and functional decline in individuals with AD), blarcamesine demonstrated a change from baseline of 0.465, aligning with the 0-0.5 point annual range seen in prodromal aging.

These data are similar to referenced barely detectable prodromal AD decline, in spite of the more advanced stage of AD impairment at baseline of the blarcamesine population.

Oral blarcamesine treatment over 48 weeks in a Precision Medicine population, including up to ~70% of the global population, indicate the ability to shift the cognitive decline of a MCI or mild AD patient population to that of a prodromal AD population.

In comparison, the respective placebo group in the ANAVEX2-73-AD-004 Phase IIb/III ABCLEAR34 population, ADAS-Cog13 LS mean declined by 5.592 points resulting in an ADAS-Cog13 LS mean difference of -4.739 [95% CI -7.370, -2.108]; P=0.0004. This represents a 84.7% reduction in decline at 48 weeks of blarcamesine treatment vs placebo on the cognitive endpoint ADAS-Cog13.

"Given the strong interest in living a longer life without Alzheimer’s dementia, novel therapeutic directions are required. Blarcamesine’s mechanism of autophagy restoration via SIGMAR1 activation addresses a non-amyloid, upstream target, representing such a highly transformative clinical innovation,” said Marwan Noel Sabbagh, MD, Professor of Neurology, and Chairman of the Anavex Scientific Advisory Board. “We are thrilled that today's findings show the superior effect of blarcamesine Precision Medicine population shifting the previous cognitive decline of Alzheimer’s disease to barely detectable decline resembling prodromal older cognitive decline.”

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