Overview

Based in the United States and Israel, Galimedix is a Phase 2 clinical stage ophthalmic pharmaceutical company led by a highly experienced pharma team, developing truly novel and transformative treatments based on a novel mechanism of action directed to the common cause for several neurodegenerative diseases: toxic oligomers of amyloid beta. Our focus is on two of the leading causes of blindness: dry macular degeneration of the retina, and glaucoma.

Galimedix has exclusive worldwide license from Tel Aviv University and Germany-based pharmaceutical company Merz Pharmaceuticals, where the compound was developed for seven years. Key members of the Merz team who developed the compound are now part of the Galimedix team. The license also includes a next generation, potentially superior compound, intended for oral administration, with the potential to treat retinal and CNS diseases.

The company is currently developing a novel treatment that delivers its patented small molecule drug with a unique mechanism of action (MOA) via eye drops. Eye drops are often used to deliver steroids and other small molecules in retinal disease and they offer a more convenient delivery, and may offer significant safety and compliance advantages over commonly-used direct ocular injections.

Studies with Galimedix's eye drops in monkeys have demonstrated drug concentration quickly reaching more than 30 times estimated therapeutic levels in the retina of the closest model to human eyes. Compelling efficacy data from GAL-101 eye drops in relevant animal models have also demonstrated more than 90 percent neuroprotection, and the treatment has drawn the active support of more than a dozen leading experts in both glaucoma and dry AMD, who also support the design of the company's proposed phase 2 studies.

Galimedix's GAL-101 is a novel small molecule with the potential to address a major unmet needs in dry AMD and glaucoma, using eye drops as a preferred route of delivery. The company is in active fundraising for its studies and would be happy to speak to those interested in this exceptional investment opportunity.

History

GAL-101 (formerly EG30, MRZ-99030) is a phase 2 small molecule drug candidate (289.3 Dalton) belonging to a new class of Aβ aggregation modulators demonstrated to specifically attract only misfolded Aβ monomers into nontoxic amorphous structures. Invented by Prof. Ehud Gazit of Tel Aviv University, it was licensed to a German pharmaceutical company (Merz Pharma), where it was developed for seven years as a fully-funded project, achieving impressive efficacy in animal models, successfully completing Phase 1 safety in 70 subjects using eye drops administration, and attaining FDA clearance for IND submission for a clinical Phase 2/3 program. Following a change in management, the pharma company pivoted away from neurology, discontinuing this program and all other neurology projects. Galimedix now owns the global exclusive license for GAL-101 and its follow-on compounds GAL-201 (formerly MRZ-14042) and is advancing their clinical development.