Galimedix completes key stage of clinical trial for treatment targeting eye and brain diseases
Ella Day | May 9, 2025 | News story | Research and Development | Galimedix Therapeutics, Neurology, Opthalmology, R&D, clinical trial, neurodegenerative conditions
Clinical biotech, Galimedix Therapeutics, has announced the completion of a single ascending dose (SAD) part of a phase 1 study of GAL-101, a novel therapy aimed to treat serious neurodegenerative eye and brain conditions.
The SAD study showed that GAL-101 was well-tolerated and has a strong safety and pharmacokinetic profile. These promising results have allowed for the next stage of the phase 1 trial, the multiple ascending dose (MAD) study set, to conclude later in 2025.
GAL-101 is a small molecule designed to prevent the aggregation of misfolded amyloid beta (Aβ) monomers, which are believed to play a central role in conditions such as Alzheimer’s disease, dry age-related macular degeneration (dry AMD) and glaucoma. The product reflects Galimedix’s ambition to advance treatment of serious eye and brain diseases using neuroprotective therapies.
“The successful completion of the SAD part of our phase 1 trial with oral GAL-101 marks an important step forward in our clinical development,” said Hermann Russ, co-founder and chief scientific officer of Galimedix. “The data we have seen so far reinforces the potential of GAL-101 as an oral therapy for central nervous system and eye diseases associated with amyloid beta pathology,” he added.
The ongoing trial will include up to 120 participants and is designed to fulfil requirements for launching planned phase 2 studies targeting the company’s three main indications. Alongside this, the company is conducting a phase 2 trial, eDREAM, with GAL-101 eyedrops for dry AMD. It anticipates that recruitment will be completed in less than a year from now.
Ella Day
9/5/25
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