Galimedix Begins Phase 1 Clinical Trial of Oral GAL-101 for Neuroprotective Treatment

Galimedix Therapeutics announced the first volunteers have been dosed in the company’s phase 1 study of oral GAL-101, an amyloid beta (Aβ) aggregation modulator. This trial is designed to assess the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of the orally administered compound.

“We are excited to enter clinical development with the oral formulation of our lead compound, GAL-101,” Dr. Alexander Gebauer, Co-Founder and Executive Chairman of Galimedix Therapeutics, said in a company news release. “GAL-101 eye drops have already demonstrated excellent safety and tolerability in early clinical testing, alongside compelling efficacy in relevant preclinical models for ophthalmic and Alzheimer’s disease applications. The results from this trial will help guide our broader clinical development program, including treatments for Alzheimer’s disease, dry age-related macular degeneration, and glaucoma.”

The phase 1 trial will involve up to 120 participants, beginning with 40 healthy volunteers in the single ascending dose (SAD) portion and 32 in the multiple ascending dose (MAD) segment. The study aims to evaluate GAL-101’s safety profile, tolerability, pharmacokinetics, and ability to cross the blood-brain barrier.

GAL-101’s oral formulation is an extension of its eye drop version, which has shown promise in earlier testing phases. By modulating amyloid beta aggregation, the compound targets key mechanisms underlying neurodegenerative and degenerative eye diseases, potentially offering groundbreaking treatment options.