KENSINGTON, Md. and SHORASHIM, Israel , Oct. 08, 2019 (GLOBE NEWSWIRE) — Galimedix Therapeutics, Inc., which is developing new solutions for neurodegenerative diseases of the retina and the brain, today announced that Chief Scientific Officer, Hermann Russ, M.D., Ph.D., will provide an overview of the company and of the new development strategy with its novel, first–in–class, investigational compound, GAL–101 at the Ophthalmology Innovation Summit at the American Academy of Ophthalmology Annual Meeting (OIS@ AAO) on October 10, 2019 in San Francisco.
GAL–101 is a small molecule and has a unique mechanism of action targeting amyloid beta oligomers in an unprecedented way. There is a growing body of evidence that the toxic amyloid beta oligomers represent a major pathological factor leading to functional loss and neurodegeneration in the retina of glaucoma and dry AMD patients. GAL–101 blocks the formation of the toxic amyloid beta oligomers at source, prevents in vitro lethal toxicity to neurons and shows pronounced neuroprotective effects in animal models. "In addition, we now have demonstrated that GAL–101 can also restore neuronal function in cells that have lost their function under the toxic influence of amyloid beta oligomers" says Dr. Russ, who will present these data.
Based on the new data on functional restoration, Galimedix now plans to conduct clinical Phase 2 studies with GAL–101 eyedrops in glaucoma and dry AMD patients. Given the drug's mechanism for clearing the toxic amyloid beta oligomers from the retinas of patients with either glaucoma or dry AMD, the goal is to prove that the GAL–101 eyedrops cause an improvement of visual function, as measured by visual fields or by microperimetry, respectively. "We have made great progress in the development of our asset and are convinced this is a unique opportunity to provide superior treatment options to patients with degenerative retina diseases in the future" states Dr. Andrew Pearlman, Founder and CEO of Galimedix Therapeutics, Inc.
GAL–101 is a proprietary compound designed to prevent the formation of all forms of toxic amyloid beta oligomers by binding with high affinity to only the misfolded form of amyloid beta monomers before they can form toxic soluble oligomers. These then rapidly conglomerate into amorphous, non–beta–sheet formations, which we call "clusters," which are innocuous. Interestingly, once GAL–101 concentration reaches effective levels it triggers formation of the clusters, which then have shown the capacity to collect additional misfolded amyloid beta monomers even in the absence of additional GAL–101 molecules, through a self–propagating mechanism. This novel "trigger effect," protected by Galimedix' patent portfolio, results in a sustained effect lasting far longer than the time a single administration of the drug remains at therapeutic levels in the retina, potentially allowing for a convenient interval application regimen for patients. Thus, GAL–101 drops may potentially provide sustained prevention of formation of toxic amyloid beta oligomers in the retina, leading to a reduction of complement response and their consequent damage. Thus GAL–101 could contribute to slowing or stopping progression, and possible restoration of neural function depressed by the chronic toxic attack.
About Galimedix Therapeutics, Inc.
Based in the United States and Israel, Galimedix is a Phase 2–ready ophthalmic pharmaceutical company with a world class drug development team advancing a novel, patented small molecule drug with a novel MOA addressing glaucoma and dry AMD utilizing an eye drops delivery platform, which may offer significant safety and compliance advantages over commonly used direct ocular injections. Eye drops are used to deliver steroids and other small molecules, like GAL–101, to the retina, and studies with Galimedix's eye drops in monkeys have demonstrated therapeutic levels quickly reaching the retina of the closest model to humans. Compelling efficacy data from GAL–101 eye drops in relevant animal models have demonstrated more than 90 percent neuroprotection, and the compound is supported by several leading experts in glaucoma and in dry AMD who also support the design of the company's proposed Phase 2 studies.
Galimedix has exclusive worldwide license from Tel Aviv University, following return of license by a German pharma (Merz) due to management change and strategic pivot away from neuroscience. The license also includes a next generation, potentially superior molecule intended for oral delivery, with potential to treat retinal and other CNS diseases.