Galimedix eyes phase 2 Alzheimer's trial after oral drug clears safety hurdle

Galimedix is raising funds for a phase 2 trial of its oral Alzheimer’s drug, GAL-101, after a successful phase 1 trial showed no serious side effects and confirmed brain penetration.

Why it matters: GAL-101 could be the first oral treatment targeting amyloid beta in Alzheimer’s, offering a more convenient alternative to current IV drugs like Leqembi and Kisunla.

Backstory: GAL-101 builds on earlier mouse studies showing reduced amyloid beta and improved learning. Specifically, GAL-101 binds to misfolded amyloid beta proteins and aims to prevent them from becoming the harmful plaques linked to Alzheimer’s. While many amyloid-targeting drugs have failed to improve cognition, GAL-101’s early success and oral delivery set it apart.

Zoom in: GAL-101 has a phase 1 and a phase 2 trial. In the phase 1, with over 100 healthy volunteers, a strong safety and pharmacokinetic profile was found. The phase 2 trial for GAL-101 in dry age-related macular degeneration began in late 2024.

Big picture: The drug’s potential as a first-in-class oral treatment could reshape Alzheimer's care, especially if it proves effective in all disease stages. Its dual use in neurodegeneration and eye disease also broadens its market impact.