GSK and Alector halted the phase 2 PROGRESS-AD trial of nivisnebart (AL101/GSK4527226), an anti-sortilin 1 antibody, after an interim futility analysis showed it was unlikely to meet the primary endpoint of slowing disease progression in early Alzheimer's patients.1
The trial involved 367 participants randomized to one of two doses or placebo; the drug aimed to elevate progranulin levels to support brain neurons and microglia.1
This failure marks the second setback for the 2021 GSK-Alector partnership, which included a $700M upfront payment, following latozinemab's phase 3 failure in frontotemporal dementia.15
Analysts at TD Cowen state the result effectively ends the GSK-Alector partnership.1
Alector's prior AbbVie-partnered Alzheimer's candidate also failed in 2024.1
Sources:
1. https://www.fiercebiotech.com/biotech/gsks-700m-alector-bet-blows-alzheimers-drug-flunks-phase-2
5. https://lifescivoice.com/alector-latozinemab-development-failure-ftd/