New York— Anavex Life Sciences Corp. (Nasdaq: AVXL), a clinical-stage biopharmaceutical company, has announced significant findings from its Phase IIb/III ATTENTION-AD (ANAVEX®2-73-AD-EP-004) trial, showing that continued treatment with its investigational drug, blarcamesine (ANAVEX®2-73), significantly slows clinical decline in early Alzheimer’s disease patients.
These results, presented at the AD/PDTM 2025 Conference, highlight the potential of blarcamesine as a disease-modifying treatment for Alzheimer’s when administered for up to four years.
The study’s open-label extension (OLE) phase, which followed an initial 48-week double-blind trial, tracked participants for an additional 96 to 144 weeks, depending on their location. The trial focused on evaluating both the long-term safety and cognitive benefits of blarcamesine. Patients treated with blarcamesine for up to four years demonstrated continued improvements in cognitive function and daily living activities, as measured by the ADAS-Cog13 and ADCS-ADL clinical scales.
Disease-Modifying Effect Seen with Early and Continuous Treatment
One of the most significant findings from the study was the indication that early and uninterrupted treatment with blarcamesine could potentially modify the course of Alzheimer’s disease. A prespecified delayed-start analysis using the Mixed Effect Model for Repeated Measures (MMRM) showed a substantial benefit in patients who began treatment earlier in the disease course. Specifically, those who received blarcamesine earlier exhibited significantly greater cognitive stability compared to those who delayed treatment.
At 192 weeks, the difference between the early-start and late-start groups on the ADAS-Cog13 scale was -3.83 points (P = 0.0165), which is considered clinically meaningful. Likewise, the ADCS-ADL scores also favored early treatment, with a mean difference of +4.30 points (P = 0.0206).
These results underscore the potential benefits of initiating treatment early and maintaining a continuous regimen to help slow disease progression, with the study indicating that early intervention could lead to greater long-term benefits.
Favorable Safety Profile with No Life-Threatening Adverse Events
Blarcamesine was well tolerated throughout the study, with a favorable safety profile. Most adverse events (AEs) were mild to moderate in severity and occurred during the initial titration phase. Dizziness, the most common treatment-emergent adverse event (TEAE), was largely transient and managed by adjusting the titration schedule. Notably, there were no treatment-related deaths or serious adverse events (SAEs) reported during the study, and no significant neuroimaging abnormalities, such as brain bleeding or swelling, were observed.
The company also noted that the majority of adverse events were mitigated by extending the titration phase from 2-3 weeks to 10 weeks, which reduced the incidence of dizziness from 25.2% in the initial phase to 9.6% in the open-label extension phase.
A Step Toward More Effective Alzheimer’s Treatments
Prof. Dr. Timo Grimmer, MD, member of Anavex’s Scientific Advisory Board, commented on the significance of the findings, noting that diagnosing and treating Alzheimer’s patients earlier in the disease continuum could provide a critical opportunity for more effective management. “These long-term results from the ATTENTION-AD trial demonstrate that early and continuous treatment with blarcamesine may offer meaningful benefits for patients, potentially marking a shift in how Alzheimer’s disease is treated,” Grimmer said.
Anavex’s CEO, Christopher U. Missling, PhD, emphasized the potential of blarcamesine to improve the lives of Alzheimer’s patients. “This is a promising step forward in the development of more effective treatments for Alzheimer’s disease. With its convenient once-daily oral dosing and favorable safety profile, blarcamesine could significantly reduce barriers to treatment and provide broader access to those in need,” Missling stated.
The company’s promising results provide a solid foundation for future clinical trials, as it plans to move forward with Phase III and IV studies to further evaluate the drug’s long-term impact on Alzheimer’s patients.
Compassionate Use Program Expands Access to Blarcamesine
In addition to the ongoing clinical trials, Anavex is offering blarcamesine through its Compassionate Use Program, which currently supports 74 participants. Some of these individuals have been on the drug for over nine years, with no reported severe or life-threatening adverse events.
The study’s results add to the growing body of evidence supporting blarcamesine’s potential as a transformative treatment for Alzheimer’s disease, with early and continuous administration offering the best prospects for disease modification.
