Alector Announces Initiation of Phase 1b Study of AL003 in Alzheimer’s Disease Patients
- Phase 1b study of AL003 will enroll approximately 12 Alzheimer’s disease patients to assess safety, pharmacokinetics and pharmacodynamics, and monitor target specific biomarkers
“We have developed AL003 to block the inhibitory function of SIGLEC 3, an immune receptor linked to Alzheimer’s disease. AL003 is intended to allow the brain’s immune system to simultaneously address multiple parallel pathologies involved in the progression of Alzheimer’s disease,” said
The Phase 1b portion of the INTERCEPT clinical study will assess the safety of multiple doses of AL003 in approximately 12 patients with mild to moderate Alzheimer’s disease. The study’s primary endpoints are safety and tolerability and the secondary endpoints are pharmacokinetics (PK), pharmacodynamics (PD), target engagement and target-specific biomarker changes related to AL003 in plasma and in cerebrospinal fluid (CSF) in Alzheimer’s disease patients.
“We evaluated the pharmacokinetics and pharmacodynamics of AL003 and found tolerable doses in a placebo-controlled, single-ascending dose escalation study in healthy volunteers. We are encouraged by the long-lasting target engagement that AL003 displayed with a blood-based biomarker even at low doses in these healthy volunteers. We look forward to evaluating AL003 in Alzheimer’s disease patients in the Phase 1b study,” said
AL003 targets sialic acid binding Ig-like lectin 3 (SIGLEC 3) that is a genetic risk factor for Alzheimer’s disease. SIGLEC 3 is an inhibitory receptor expressed primarily on cells of myeloid lineage including microglia, which constitute the brain’s immune system. AL003 is a monoclonal antibody that works by blocking the function of SIGLEC 3 to increase the activity of microglia and that is intended to treat Alzheimer’s disease.
About Alzheimer’s Disease
Alzheimer’s disease is a degenerative brain disease and the most common cause of dementia. It is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and eventually the ability of patients to care for themselves. In most people with Alzheimer’s disease, symptoms first appear in their mid-60s. The Alzheimer’s Association estimates that as of 2018 there are 5.7 million Americans suffering from Alzheimer’s disease and project that number will rise to nearly 14 million by 2050.
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Source: Alector, Inc.