Overview

Based in the United States, Galimedix is a Phase 2 clinical stage pharmaceutical and ophthalmic company developing transformative treatments based on a novel mechanism of action directed to the common cause for several neurodegenerative diseases: toxic oligomers of amyloid beta (Aβ). Our initial focus is on our Phase 2-ready eye drop treatment for two of the leading causes of blindness: dry age-related macular degeneration (dry AMD) of the retina, and glaucoma, with treatment of Alzheimer’s disease in pipeline. For long term treatments required for glaucoma and dry AMD, eye drops offer a more convenient administration, and may offer significant safety and convenience / tolerance advantages over commonly-used direct ocular injections

Founded by bio entrepreneur Dr. Andrew Pearlman, Galimedix has an exclusive worldwide license from Tel Aviv University including all the data generated by Germany-based pharmaceutical company Merz Pharmaceuticals, where the compounds were licensed and developed for seven years. The license also includes a next generation, potentially superior compound GAL-201, intended for oral administration, with the potential to treat retinal and CNS diseases. Key members of the top neuropharmaceutical team of Merz, who developed the block buster Alzheimer’s drug Namenda (Memantine) and who led the efforts on GAL-101 and GAL-201, are now leading the efforts at Galimedix.

Pharmacokinetic studies with GAL-101 eye drops in monkeys have demonstrated drug concentrations quickly reaching more than 30 times estimated target affinity in the retina of the closest model to human eyes. Compelling efficacy data from GAL-101 eye drops in relevant animal models (Morrison rat model of glaucoma) have also demonstrated more than 90 percent neuroprotection. Leading experts in both glaucoma and dry AMD support the design of the company's proposed Phase 2 studies.

History

GAL-101 (formerly EG30, MRZ-99030) is a Phase 2 small molecule drug candidate (289.3 Dalton) belonging to a new class of Amyloid beta (Aβ) aggregation modulators demonstrated to effectively and specifically attract only misfolded Aβ monomers and transform them into nontoxic amorphous structures, thus preventing their formation into toxic Aβ oligomers. Invented by Prof. Ehud Gazit of Tel Aviv University as a potential Alzheimer drug, it was licensed to a German pharmaceutical company (Merz Pharma). Prof. Hermann Russ (at that time with Merz Pharma, now CSO of Galimedix) recognized the potential of GAL-101 as treatment for degenerative retinal diseases. GAL-101 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. However, following a change in management, the pharma company pivoted away from neurology / ophthalmology, and Galimedix now owns the global exclusive license for GAL-101 and its follow-on compound GAL-201 (formerly MRZ-14042) and is advancing their development.