Galimedix Therapeutics has completed the single ascending dose (SAD) portion of its Phase 1 study for oral GAL-101, a small molecule drug targeting misfolded amyloid beta monomers. The study, involving 40 healthy volunteers, demonstrated that GAL-101 was well-tolerated and exhibited a favorable safety and pharmacokinetic profile, supporting its intended oral administration route. The company is developing GAL-101 for dry age-related macular degeneration (AMD), glaucoma, and Alzheimer’s disease.
This positive Phase 1 data is a critical milestone for Galimedix, validating the drug’s safety and pharmacokinetic properties in humans. The successful demonstration of oral bioavailability opens the door for convenient, long-term treatment options for chronic neurological and ophthalmological conditions, potentially improving patient adherence and therapeutic outcomes. This development also expands the potential market reach of GAL-101 by making it accessible to a wider patient population compared to more invasive administration methods.
The Phase 1 trial, enrolling up to 120 participants, is designed to gather comprehensive data needed for planned Phase 2 studies in Alzheimer’s disease, dry AMD, and glaucoma. Parallel to this, Galimedix is conducting a Phase 2 trial (eDREAM) with GAL-101 eyedrops for dry AMD, with recruitment expected to finish within a year. Pre-clinical studies suggest that GAL-101 can prevent and eliminate toxic amyloid beta species, potentially offering neuroprotective and symptomatic benefits in Alzheimer’s disease. Furthermore, the oral formulation has shown promising pre-clinical results in ophthalmic models, protecting retinal cells from damage.
This successful SAD portion of the Phase 1 trial sets the stage for the next phases of clinical development for oral GAL-101. Positive results from the ongoing and upcoming studies could position GAL-101 as a promising therapeutic candidate for multiple indications with significant unmet medical needs, potentially impacting the treatment landscape for neurodegenerative and eye diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
