Alector’s internal pipeline suffered a blow as the Phase II INVOKE-2 trial evaluating its Alzheimer’s disease therapy, AL002, failed to meet the primary endpoint.
The therapy failed to slow disease progression in patients with early Alzheimer’s in the INVOKE-2 trial (NCT04592874). Alector did not provide detailed results from the INVOKE-2 trial, stating it would share them later at a scientific conference. The company said that the study did not note any “treatment effects that favoured AL002 on secondary clinical and functional endpoints”.
Furthermore, Alector noted that “there were no significant effects on Alzheimer’s fluid biomarkers favouring AL002, and amyloid PET imaging demonstrated no treatment-related reduction of brain amyloid levels”.
The Californian biotech noted that it is discontinuing the long-term extension trial (NCT05744401) for AL002 in Alzheimer’s following the negative trial data.
Alector also laid off about 17% of its workforce to “align resources” with “strategic priorities”. Following the announcement, the company’s stock was down by over 31% in premarket trading today (26 November). Alector also reported $457m in cash reserves as of 30 September, which the company expects will keep it operational through 2026.
Alector plans to direct its resources into the monoclonal antibodies programmes it is developing in partnership with GSK. The companies are evaluating latozinemab as a treatment for frontotemporal dementia due to heterozygous mutations in the progranulin gene in a pivotal Phase III INFRONT-3 trial (NCT04374136). The results from the study are expected in late 2025/early 2026.
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By GlobalDataThe second drug, AL101, being developed as part of the GSK collaboration is being evaluated as a treatment for early Alzheimer’s disease. The PROGRESS-AD Phase II trial (NCT06079190) is currently recruiting participants. Alector stated that the study has reached more than one-third of its target enrolment of 282 participants.
Alector is not the only company that suffered a setback in developing Alzheimer’s therapy this week. Cassava Sciences also had to discontinue the development of its lead Alzheimer’s treatment, simufilam, after it failed to meet the primary endpoints in a Phase III ReThink-ALZ study (NCT04994483).