Anavex Life Sciences Corp. (NASDAQ:AVXL) announced the latest findings on Thursday for blarcamesine, an oral small molecule that could potentially treat early Alzheimer’s disease.

The data were presented at the 2025 Alzheimer’s Association International Conference.

The ATTENTION-AD (ANAVEX2-73-AD-EP-004) open-label extension (OLE) Phase 2b/3 treatment trial followed the 48-week ANAVEX2-73-AD-004 double-blind (DB) clinical trial, with a combined duration of up to 192 weeks.

Also Read: Anavex Life Sciences Reports Prolonged Benefit Data Of Blarcamesine In Early Alzheimer’s Over 3 Years

The trial was designed to evaluate the safety and tolerability of blarcamesine and its long-term effects on cognition (ADAS-Cog13) and function (ADCS-ADL) in participants with early Alzheimer’s disease.

Blarcamesine-treated patients continue to accrue benefits for up to 4 years.

In the intent-to-treat (ITT) population, delayed-start analysis of treatment with oral blarcamesine was significant for both cognition and function, reflecting the importance of early treatment initiation.

For ADAS-Cog13, a significant difference between the early-start and late-start treatment groups at Week 192 was observed.

Similarly, for ADCS-ADL at Week 192, statistical significance (LS mean difference +4.30, P = 0.0206) was reached, favoring the early-start group.

Additionally, the GWAS-identified population ABCLEAR2, with a global frequency of ~71.7%, showed further improvement in cognition, ADAS-Cog13, and function, ADCS-ADL, respectively.

This clinical Precision Medicine population data demonstrates up to 84.6 Weeks (19.5 Months) of ‘time saved’ by the early-start analysis.

In Alzheimer’s disease clinical trials, ‘time saved’ refers to the estimated amount of time a treatment delays the progression of the disease, allowing patients to maintain functionality and independence longer.

Further presentations at the AAIC 2025 Conference featured prespecified Precision Medicine Phase 2b/3 48-week ANAVEX2-73-AD-004 DB trial data on blarcamesine, confirming the upstream mechanism of blarcamesine, restoring impaired autophagy as an early event, preceding amyloid-beta and tau.

A clinical Precision Medicine approach confirmed that the prespecified SIGMAR1 non-mutated population achieved deeper clinical responses to blarcamesine than the respective ITT population.

While in the ITT population, trial participants showed significant improvement versus placebo after 48 Weeks in the ANAVEX2-73-AD-004 DB trial by 36.3% for the key endpoints, ADAS-Cog13, and 27.6% for CDR-SB, respectively, a further, also significant, improvement was observed in the prespecified analysis of SIGMAR1 wild-type (WT) carriers, the ABCLEAR1 population.

Compared to the ITT population, the ABCLEAR1 population demonstrated additional and consistent improvement versus placebo. ADAS-Cog13 and CDR-SB for the total blarcamesine group improved by 49.8% and 33.6%, respectively, and for the 30 mg blarcamesine group by 49.1% and 35.5%, respectively.

For the 30 mg blarcamesine group, serious treatment-emergent adverse events occurred in 10 participants (12.7%) receiving blarcamesine and in 6 participants (9.1%) receiving placebo.

Price Action: AVXL stock is up 1.61% at $11.35 during the premarket session at the last check on Thursday.

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