Presents Baseline Characteristics for INVOKE-2 Phase 2 Clinical Trial of AL002 at the Alzheimer's Association International Conference 2024 (AAIC)
- INVOKE-2 is the first global Phase 2 trial evaluating the safety and efficacy of a TREM2 agonist, AL002, in slowing disease progression in individuals with early Alzheimer’s disease (AD)
- Baseline characteristics data for the INVOKE-2 study confirm a representative study population that enables testing of the effects of a novel TREM2 agonist in early ADnnounced 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 (AD) at the Alzheimer's Association International Conference® 2024 (AAIC®). 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 (mAb) that binds to triggering receptor expressed on myeloid cells 2 (TREM2), 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. The median age of participants was 71 years (range: 51-85 years), with 78% of participants 65 years of age or older. Overall, 50% of participants were female and 94% were Caucasian. The clinical diagnosis at enrollment was mild cognitive impairment due to AD for 67% of participants and mild dementia due to AD for 33% of participants.Treatment-emergent brain MRI changes resembling amyloid-related imaging abnormalities (ARIA) 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 (Positron Emission Tomography). For those participants (n=244) with amyloid PET assessed at baseline, the mean standard deviation (SD) in centiloids was 100.1 (38.9).
Additional details will be presented during the poster presentation, “Baseline Characteristics for INVOKE-2: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating AL002 in Early Alzheimer’s Disease” (#95594) on Sunday, July 28, 2024, from 8:00 a.m. – 4:15 p.m. ET at AAIC®.A Phase 1 study of AL002 demonstrated dose-dependent target engagement and dose-dependent effects on microglial signaling biomarkers, and the treatment was well-tolerated in healthy volunteers at multiple doses.
Results of the INVOKE-2 trial are expected in the fourth quarter of 2024, and the long-term extension (LTE) study is ongoing for those who completed the planned treatment period. Thus far, nearly all eligible participants have rolled over into the LTE study, which will facilitate better understanding of the long-term effects of AL002.