Galimedix Therapeutics Initiates Phase 2 Study of GAL-101 Eye Drops for Dry AMD

Galimedix Therapeutics has announced the initiation of a phase 2 clinical study called eDREAM (NCT06659549), evaluating the efficacy and safety of GAL-101 eye drops in patients with dry age-related macular degeneration (AMD) and geographic atrophy (GA).

About the Phase 2 Study

This randomized, double-blind, placebo-controlled, multicenter trial aims to enroll up to 110 patients, randomized 1:1 to receive either GAL-101 eye drops or a placebo. The primary endpoint of the trial is the reduction in the rate of change of GA lesion size.

The study will also assess:

       • Reduction in the rate of change in photoreceptor degeneration area.

       • Various functional outcomes, including retinal sensitivity measured via microperimetry with a tailored grid design for each patient.

Expert Insights on GAL-101

Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer of Galimedix, expressed optimism about the trial:

"We are excited to start this trial, which was designed in collaboration with leading global experts in AMD. GAL-101 eye drops have already shown an excellent safety and tolerability profile in phase 1 clinical testing, and compelling efficacy with GAL-101 protecting neuronal retinal cells from toxic damage has been demonstrated in relevant ophthalmic preclinical models. 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.”

Understanding GAL-101

GAL-101 is a small molecule drug targeting misfolded amyloid-beta (Aβ) monomers. By preventing the formation of toxic Aβ oligomers and protofibrils, GAL-101 addresses a major underlying cause of neurodegenerative diseases.

Key Features of GAL-101

       • Developed in oral and topical (eye drop) formulations.

       • Targets misfolded Aβ species while preserving healthy forms.

       • Demonstrated neuroprotection and prevention of toxic damage in preclinical ophthalmic models.

       • Proven safety and tolerability in previous phase 1 clinical testing.

Broader Applications

GAL-101 is being investigated for its potential to treat:

       • Dry AMD and geographic atrophy.

       • Glaucoma.

       • Alzheimer’s disease, where Aβ targeting has been validated by recent drug approvals.

In preclinical studies, GAL-101 eye drops not only protected neuronal retinal cells but also demonstrated the potential for symptomatic relief and neuroprotection in models of Alzheimer’s disease.

Looking Ahead

With the launch of the eDREAM trial, Galimedix Therapeutics aims to provide a safe, effective, and patient-friendly treatment for dry AMD, addressing an urgent unmet need in the ophthalmic community. The outcomes of this pivotal trial could mark a significant advancement in the treatment landscape for neurodegenerative eye diseases.