Galimedix Therapeutics Initiates Phase 2 Study with GAL-101 Eye Drops in Dry AMD
Galimedix Therapeutics announced the initiation of a phase 2 study (eDREAM; NCT06659549) with GAL-101 eye drops in patients with dry age-related macular degeneration (AMD). The randomized, double-blind, placebo-controlled multicenter study will evaluate the efficacy and safety of GAL-101 eye drops in patients with geographic atrophy (GA).
“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,” Hermann Russ, MD, PhD, Co-founder and CSO of Galimedix, said in a company news release. “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.”
The Phase 2 study is planned to enroll up to 110 patients, who will be randomized 1:1 to receive study drug or placebo. The primary endpoint of the trial is reduction in rate of change of GA lesion size. The trial will also evaluate the reduction in rate of change in the area of photoreceptor degeneration and various functional outcome measures, including retinal sensitivity on microperimetry with patient-tailored grid design.
About GAL-101
GAL-101 is a small molecule targeting misfolded Aβ monomers and thus preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eye drops) formulations. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the retina, and recent approvals of anti-Aβ drugs also have validated them as a key target in Alzheimer’s disease. GAL-101 is being developed for the treatment of dry AMD, glaucoma, and Alzheimer’s disease. In a previous Phase 1 study, GAL-101 eye drops demonstrated an excellent safety and tolerability profile. In pre-clinical testing, the compound has been shown to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. Robust efficacy has been demonstrated in relevant ophthalmic pre-clinical models, protecting neuronal retinal cells from toxic damage. GAL-101 has also demonstrated the potential for neuroprotection and symptomatic alleviation in pre-clinical models of Alzheimer’s disease.