Galimedix Therapeutics has announced the initiation of the eDREAM phase 2 clinical trial, evaluating GAL-101 eye drops for patients with geographic atrophy (GA) resulting from dry age-related macular degeneration (AMD). This condition is a leading cause of vision loss in older adults, highlighting the urgent need for effective treatments.
The eDREAM trial (NCT06659549) is a randomized, double-blind, placebo-controlled, multicenter study designed to enroll up to 110 patients across multiple sites in the US, Europe, and Israel. Participants will receive either GAL-101 or a matching placebo, administered as three drops at 5-minute intervals during clinic visits, and twice daily between visits. The treatment period will last between 12 to 24 months, with all patients participating for a minimum of 12 months.
Targeting Geographic Atrophy
The primary endpoint of the eDREAM trial is to assess the reduction in the rate of change in GA lesion size, as measured by fundus autofluorescence. Secondary outcomes include evaluating the rate of change in photoreceptor degeneration using optical coherence tomography (OCT).
According to Hermann Russ, MD, PhD, co-founder and CSO of Galimedix, GAL-101 has demonstrated an excellent safety and tolerability profile in Phase 1 clinical testing. Preclinical models have also shown that GAL-101 protects neuronal retinal cells from toxic damage. "Despite recent advances, there remains a need to offer patient-friendly, safe, and effective treatment options for this disease, and we look forward to seeing the results from this important trial," said Dr. Russ.
GAL-101: A Novel Approach
GAL-101 is a small molecule designed to target misfolded amyloid-beta (Aβ) monomers, preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eye drop) formulations for the treatment of dry AMD, glaucoma, and Alzheimer’s disease. Galimedix has also initiated a Phase 1 clinical trial of oral GAL-101 to assess its safety, tolerability, and pharmacokinetics.
Broader Implications
Studies suggest that toxic Aβ aggregates are a major underlying cause of neurodegenerative diseases affecting the eye. Recent approvals of anti-Aβ drugs have validated Aβ as a key target in Alzheimer’s disease, suggesting a potential for GAL-101 in treating a range of neurodegenerative conditions. Preclinical studies have demonstrated GAL-101’s ability to prevent and eliminate toxic Aβ species while preserving healthy forms of Aβ, showing potential for neuroprotection and symptomatic alleviation in preclinical Alzheimer’s disease models.
