Galimedix Therapeutics, a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies for serious brain and retinal diseases, announced the successful completion of its Phase 1 clinical study of GAL-101, an orally administered small molecule designed to target misfolded amyloid beta (Aβ) monomers.

The trial demonstrated that GAL-101 was well tolerated with an excellent safety profile and no serious adverse events reported. The study further confirmed that GAL-101 effectively crosses the blood-brain barrier, with a pharmacokinetic profile strongly supporting oral administration and advancing into Phase 2 development for Alzheimer’s disease. Full results from the study are expected to be presented at an upcoming scientific conference.

“Completing our first clinical trial with the oral formulation of GAL-101 marks a major milestone for Galimedix,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman of Galimedix. “We are encouraged that the study confirmed GAL-101’s favorable safety profile and pharmacokinetics, which strongly support its continued development for Alzheimer’s disease. We are now planning a Phase 2 trial in this devastating condition, where effective treatment options remain very limited. GAL-101 has the potential to become the first-in-class therapy and future standard of care for patients at all stages of Alzheimer’s, including those with mild cognitive impairment.”

The Phase 1 trial enrolled more than 100 healthy volunteers and assessed the safety, tolerability, and pharmacokinetics of both single (SAD) and multiple (MAD) ascending oral doses of GAL-101. The study also examined the compound’s ability to cross the blood-brain barrier, as well as the impact of food intake, age, and gender—critical parameters required to initiate the upcoming Phase 2 program.

In addition to Alzheimer’s development, Galimedix is advancing GAL-101 eyedrops in a Phase 2 clinical trial for dry age-related macular degeneration (dAMD) through the ongoing eDREAM study across the United States, Europe, and other regions. This program, focused on dAMD and geographic atrophy (GA), is partner-funded, reducing the company’s financial exposure while advancing a potentially transformative therapy for retinal diseases.

Galimedix is actively engaging with investors and potential partners to discuss available data, development plans, and strategic opportunities.