GSK4527226 (AL101) is a monoclonal antibody therapeutic candidate developed by GlaxoSmithKline (GSK) in collaboration with Alector Inc. that targets progranulin (PGRN) for the treatment of early Alzheimer's disease.
Extension Trial Identifier: NCT07105709
Parent Trial: NCT06079190 (PROGRESS-AD)
Status: Recruiting
Estimated Enrollment: 220 participants
Sponsor: GlaxoSmithKline
This open-label extension (OLE) study allows participants who completed the parent Phase 2 trial (NCT06079190) to continue receiving AL101 treatment in an unblinded manner. The OLE provides:
Participants receive AL101 via intravenous infusion according to the dosing schedule established in the parent trial. The specific dose administered in the OLE will depend on the dose received during the parent study.
The extension study is actively recruiting participants who have completed participation in the parent Phase 2 trial. No published results are currently available.
When results become available, this extension study will provide:
AL101 is designed to elevate progranulin (PGRN) levels in the brain. Progranulin is a multifunctional growth factor that plays critical roles in:
The therapeutic approach is supported by human genetics: heterozygous mutations in the GRN gene that reduce progranulin levels by ~50% are associated with increased risk of Alzheimer's disease.
| Milestone | Date |
|---|---|
| Parent trial start (NCT06079190) | October 2023 |
| OLE start date | Ongoing (2025-2026) |
| Parent trial completion | November 2026 (estimated) |
| OLE completion | To be determined |
Based on the progranulin mechanism:
The open-label extension provides critical long-term data for a novel therapeutic approach targeting progranulin. Unlike amyloid-targeting antibodies (lecanemab, donanemab), AL101 addresses a different pathway implicated in neurodegeneration through modulation of lysosomal function and microglial biology.