Galimedix Therapeutics initiates eDREAM phase 2 clinical trial in dry age-related macular degeneration

Galimedix Therapeutics announced the initiation of eDREAM (NCT06659549), its phase 2 clinical trial of GAL-101 eye drops in patients with geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD).

eDREAM is a randomized, double-blind, placebo-controlled multicenter study expected to enroll up to 110 patients. During patient visits, patients will be administered 3 applications of 1 drop of GAL-101 or a matching placebo at 5-minute intervals. In between visits, patients will also be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day. The study will be comprised of a 12- to 24-month treatment period, will all patients participating at a minimum of 12 months.^1,2

The primary outcome for the trial will be the reduction in rate of change in GA lesion size as measured by fundus autofluorescence. Secondary outcome is reducing the rate of change in photoreceptor degeneration in eyes with GA as measured by optical coherence tomography (OCT).^1,2

Hermann Russ, MD, PhD, co-founder and CSO of Galimedix commented on the trial in a press release from the company.¹

“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 pre-clinical models,” said Russ. “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.”

GAL-101 is a small molecule targeting misfolded Aβ monomers and is being developed in both oral and topical (eye drops) formulations.¹ Galimedix recently announced dosing had started in its phase 1 clinical trial of oral GAL-101.

GAL-101 is being developed for the treatment of dry AMD, glaucoma, and Alzheimer’s disease.

References:

1. Galimedix Therapeutics initiates pivotal Phase 2 study with GAL-101 eye drops in dry AMD. Press Release; December 23, 2024. Accessed January 2, 2025. https://finance.yahoo.com/news/galimedix-therapeutics-initiates-pivotal-phase-163000620.html

2. A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD (eDREAM). Accessed January 2, 2025. https://clinicaltrials.gov/study/NCT06659549