Alector presents baseline characteristics for INVOKE-2 Phase 2 trial of AL002

Alector announced the presentation of a poster on baseline characteristics for the global INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease at the Alzheimer’s Association International Conference 2024. The conference is being held online and in Philadelphia, Pennsylvania from July 28 – August 1, 2024. INVOKE-2 is the first global Phase 2 trial exploring a novel TREM2 agonist, AL002, in early AD. AL002 is an investigational humanized monoclonal antibody that binds to triggering receptor expressed on myeloid cells 2, and it is the most advanced TREM2 agonist product candidate in clinical trials. The candidate is being developed in collaboration with AbbVie. Baseline characteristics are important in Phase 2 trials because they ensure the reliability and interpretability of trial results, help manage patient safety, and facilitate appropriate statistical analyses. A total of 381 participants were randomized in INVOKE-2. Treatment-emergent brain MRI changes resembling amyloid-related imaging abnormalities have been observed in the trial. These changes were of greater incidence and severity in homozygous APOE e4 carriers, and the company chose to discontinue homozygous APOE e4 carriers early in the trial. Of the 381 enrolled participants, 59% were heterozygous APOE e4 carriers. Amyloid positivity was confirmed in all participants prior to enrollment by analysis of cerebrospinal fluid or amyloid PET. For those participants with amyloid PET assessed at baseline, the mean standard deviation in centiloids was 100.1. Results of the INVOKE-2 trial are expected in the fourth quarter of 2024, and the long-term extension study is ongoing for those who completed the planned treatment period.