Galimedix Therapeutics, Inc.’s GAL-101 Gains from Target Validation by Positive Phase 3 Results of Biogen’s Aducanumab

KENSINGTON, Md., Oct. 29, 2019 (GLOBE NEWSWIRE) — Galimedix Therapeutics, Inc., an emerging leader in the development of new solutions for neurodegenerative diseases of the retina and the brain, today announced that the recent positive results of a Phase 3 study in Alzheimer's disease with Biogen's aducanumab also validate the target of the company's lead molecule, GAL–101.

"Following decades of failure in large Alzheimer neuroprotection trials, the recent Biogen announcement may be considered a breakthrough and a validation of amyloid beta oligomers as a target for new Alzheimer drugs," commented the company's chief scientific officer, Hermann Russ, M.D., Ph.D. "Aducanumab and GAL–101 share that they both clear the highly toxic amyloid beta oligomers. However, GAL–101 has the advantage of being a small molecule and blocks the formation of all forms of toxic oligomers at source while the antibody eliminates them only after their formation."

Aducanumab is an antibody binding specifically to aggregated amyloid beta monomers, which are also called amyloid beta oligomers. The company considers the recently announced aducanumab results in Alzheimer's disease to be validation for GAL–101 eyedrops, which target the same amyloid beta pathology in dry macular degeneration (AMD) and glaucoma. A Phase 2 program in these two indications using GAL–101 eyedrops is currently under development. An additional oral formulation of GAL–101 is in IND–enabling studies and the company believes studies in Alzheimer patients with GAL–101 capsules could start in 2021.

"These results represent a long–awaited reward for companies like Galimedix that never gave up their strong belief in amyloid beta being the right target for Alzheimer's disease, if only addressed appropriately," added Galimedix' executive chairman of the board, Alexander Gebauer, M.D., Ph.D. "Small molecules like GAL–101 have the potential to revolutionize the treatment of amyloid beta–driven diseases like dry AMD, glaucoma and Alzheimer s. We look forward to continuing to learn about the aducanumab results, as well as to sharing our own successes in targeting amyloid beta."

About Galimedix Therapeutics, Inc.
Based in the United States and Israel, Galimedix is a Phase 2/3–ready pharmaceutical company with a world–class drug development team advancing a novel, patented small molecule drug with a unique MOA addressing glaucoma, dry AMD. The company's most advanced compound, GAL–101, which utilizes an eye drop delivery platform, is expected to provide an effective, convenient and safe treatment for two of the leading causes of blindness. Studies with Galimedix's eye drops in monkeys, the closest model to humans, have demonstrated that therapeutic levels are quickly reached in the retina. Compelling efficacy data from GAL–101 eye drops in relevant animal models have demonstrated more than 90 percent neuroprotection, and in vitro studies in neuronal cells that have lost function have shown that GAL–101 can restore the neural function, suggesting it could potentially improve visual function in patients. The Company has successfully completed Phase 1 studies in 70 subjects, including 30 glaucoma patients. The compound is supported by many of the world's leading experts in glaucoma and in dry AMD, who also support the design of the company's proposed Phase 2 and Phase 3 studies.

GAL–101 is also potentially capable for oral delivery and is in active development towards Phase 1 studies with the oral formulation. In this oral formulation GAL–101 can be developed as treatment of Alzheimer's disease.

Contact:

Jules Abraham
Core IR
julesa@coreir.com
917–885–7378

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