Galimedix Therapeutics initiates pivotal Phase 2 study with GAL-101 eye drops in dry AMD

• Study to assess ability of GAL-101 eye drops in slowing or stopping the growth of geographic atrophy, a severe form of age-related macular degeneration
• Trial planned to enroll 110 patients in the US, Europe, and Israel
• Study design discussed with FDA and EU authority and supported by world-leading retina experts
• This milestone follows recent initiation of a Phase 1 study for an oral formulation of GAL-101
• Both studies are executed by Galimedix and fully funded by collaboration partner Théa Open Innovation (TOI)

Kensington, MD, USA, December 23^rd, 2024 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, today announced the initiation of a Phase 2 study (eDREAM; NCT06659549) with GAL-101 eye drops in patients with dry age-related macular degeneration (dry AMD), a leading cause of adult blindness. The randomized, double-blind, placebo-controlled multicenter study will evaluate the efficacy and safety of GAL-101 eye drops in patients with geographic atrophy, an advanced form of dry AMD.

“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 pre-clinical models,” says Hermann Russ, MD, PhD, Co-founder and CSO of Galimedix. “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 geographic atrophy 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.

About Galimedix Therapeutics, Inc. 

Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives, and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry AMD, glaucoma, and Alzheimer’s disease - Galimedix’s areas of focus.

About Théa Open Innovation

Théa is the leading independent European pharmaceutical company specialized in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned and run company has continued to expand by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Its products are available in 75 countries. Théa Open Innovation (TOI) is a sister company of Théa. TOI's mission is to set up partnerships with companies and universities to help bring the most innovative products in eye care to the market.

For more information, visit www.theaopeninnovation.com

Contact  

Alexander Gebauer, MD, PhD 

Galimedix Therapeutics, Inc. 

Co-founder and Executive Chairman  

info@galimedix.com

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