Galimedix Therapeutics has completed the single ascending dose (SAD) portion of its phase 1 clinical trial for GAL-101, an oral small molecule designed to target misfolded amyloid beta (Aβ) proteins. The study involved 40 healthy volunteers and found the drug to be well tolerated, with no serious safety concerns and a favorable pharmacokinetic profile.

GAL-101 is being developed in both oral and topical formulations for the treatment of dry age-related macular degeneration (AMD), glaucoma, and Alzheimer’s disease. The completion of the SAD phase allows the company to move forward with the multiple ascending dose (MAD) part of the study, which is expected to conclude in late 2025. The full phase 1 trial is expected to enroll up to 120 participants.

The company is also conducting a separate phase 2 trial of GAL-101 in eyedrop form for dry AMD. Recruitment for that study, called eDREAM, is expected to finish within a year.

In preclinical models, GAL-101 has shown the ability to prevent and eliminate toxic amyloid beta aggregates while sparing healthy forms of the protein. The compound has also demonstrated potential neuroprotective and symptom-alleviating effects, with minimal systemic toxicity and no antibody-specific side effects.