Alector Announces Completion of Enrollment in the INVOKE-2 Phase 2 Clinical Trial of AL002, a TREM2 Monoclonal Antibody, in Individuals With Early Alzheimer’s Disease

Data readout expected in Q4 2024

SOUTH SAN FRANCISCO, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, today announced that it has completed enrollment in INVOKE-2, the Phase 2 clinical trial of AL002. INVOKE-2 is evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Data from the trial are expected in the fourth quarter of 2024. AL002 is a novel investigational humanized monoclonal antibody (mAb) that binds to triggering receptor expressed on myeloid cells 2 (TREM2). AL002 is the most advanced TREM2 activating product candidate in clinical trials and is being developed in collaboration with AbbVie.

“The successful completion of enrollment in the INVOKE-2 Phase 2 trial marks a significant milestone in the ongoing development of AL002, bringing us one step closer to potentially introducing this prospective new class of therapeutics to individuals impacted by Alzheimer's disease,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We are also encouraged to see that nearly all eligible participants are rolling over into the long-term extension of the INVOKE-2 trial, which will enable us to better understand the long-term effects of this potential therapeutic. Notably, results from a Phase 1 clinical trial of AL002 in healthy volunteers demonstrated both dose dependent target engagement and activation of microglia. We look forward to an INVOKE-2 data readout in the fourth quarter of 2024, which will inform a potential pivotal Phase 3 clinical development program for AL002 that enables registration.”

INVOKE-2 is a randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 clinical trial being conducted at multiple sites across 11 countries. Participants with early AD are randomized to receive AL002 or placebo administered intravenously every four weeks. The trial utilizes a common close design with up to 96 weeks of randomized treatment, and all participants remain on their assigned regimen until the last participant completes 48 weeks of treatment. This design provides the opportunity to capture more observations for the primary analysis. The primary endpoint is disease progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR-SB). The CDR-SB, which is used to assess (score) the severity of AD, is a validated instrument that assesses both cognitive and functional domains and is the accepted efficacy endpoint for FDA. The trial also employs other multiple clinical and functional outcome assessments. Additionally, the trial includes cerebrospinal fluid (CSF) and plasma biomarkers assessing microglial activation and Alzheimer’s pathophysiology, as well as brain magnetic resonance imaging (MRI) and amyloid beta and tau positron emission tomography (PET) imaging.