GAL-101 / Galimedix Therapeutics - LARVOL DELTA

eDREAM: A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD (clinicaltrials.gov) - P2 | N=110 | Recruiting | Sponsor: Galimedix Therapeutics Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Galimedix Therapeutics initiates pivotal Phase 2 study with GAL-101 eye drops in dry AMD (GlobeNewswire) - "Galimedix Therapeutics, Inc...today announced the initiation of a Phase 2 study...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....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."

Trial status • Dry Age-related Macular Degeneration

eDREAM: A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD (clinicaltrials.gov) - P2 | N=110 | Not yet recruiting | Sponsor: Galimedix Therapeutics Inc

New P2 trial • Age-related Macular Degeneration • Dry Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders

Potential Therapeutic Candidates for Age-Related Macular Degeneration (AMD). (PubMed, Cells) - "This review article discusses the potential candidates for AMD therapy and their known mechanisms of cytoprotection in AMD. These target therapeutic candidates include APE/REF-1, MRZ-99030, Ciliary NeuroTrophic Factor (CNTF), RAP1 GTPase, Celecoxib, and SS-31/Elamipretide."

Journal • Review • Age-related Macular Degeneration • Immunology • Inflammation • Macular Degeneration • Metabolic Disorders • Ophthalmology • Retinal Disorders

The Aβ aggregation modulator MRZ-99030 prevents and even reverses synaptotoxic effects of Aβ on LTP even following serial dilution to a 500:1 stoichiometric excess of Aβ, suggesting a beneficial prion-like seeding mechanism. (PubMed, Neuropharmacology) - "MRZ-99030, when serially diluted with Aβ, was also capable of detoxifying/reversing an already established neurotoxic process. In TEM experiments, Aβ oligomers/annular protofibrils were converted to amorphous Aβ clusters following incubation with serially diluted MRZ-99030 to a final concentration of MRZ-99030 (20 nM) and Aβ (10 μM)."

Journal • Age-related Macular Degeneration • Alzheimer's Disease • CNS Disorders • Complement-mediated Rare Disorders • Gene Therapies • Glaucoma • Macular Degeneration • Ophthalmology • Retinal Disorders

Galimedix Therapeutics, Inc.’s GAL-101 gains from target validation by positive phase 3 results of Biogen’s aducanumab (GlobeNewswire) - "Galimedix Therapeutics, Inc....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."

New trial • Trial status

Galimedix Therapeutics, Inc. To Present at Ophthalmology Innovation Summit During the American Academy of Ophthalmology Meeting (GlobeNewswire, Galimedix) - "Galimedix Therapeutics, Inc...announced that Chief Scientific Officer, Hermann Russ, M.D., Ph.D., will provide an overview of the...new development strategy with...GAL-101 at the Ophthalmology Innovation Summit at the American Academy of Ophthalmology Annual Meeting (OIS@ AAO) on October 10, 2019 in San Francisco...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."

New P2 trial

Preclinical Studies Demonstrate Galimedix Therapeutics’ Investigational Compound GAL-101 Shows Neuroprotective Effect from Toxic Amyloid-Beta in Dry AMD and Glaucoma Models (GlobeNewswire, Galimedix) - Galimedix Therapeutics, which is developing new solutions for ophthalmic and neurodegenerative diseases, today presented data demonstrating its novel, first-in-class, investigational compound GAL-101 provides neuroprotection from misfolded amyloid beta molecules aggregating into toxic forms in vitro, neutralizing their ability to be toxic to neural tissues. “The unique mechanism of action of GAL-101 has been shown to reduce the levels of amyloid beta present in the retina, thereby both preventing neurodegeneration and increasing the chances of preventing vision loss.

P1 data • Preclinical

Sustained neuroprotective effect of novel Aβ aggregation modulator GAL-101 shown in dry AMD and glaucoma models with transient peak concentrations using eye drops (ARVO 2019) - "...GAL-101 (formerly MRZ-99030), a novel small molecule, selectively clears misfolded Aβ from neural tissues to prevent formation of neurotoxic Aβ oligomers and their consequent neurotoxicity...Conclusions These results suggest that when a transient GAL-101 peak exceeds a threshold in a toxic Aβ solution it triggers a sustained detoxification, apparently facilitated by the “blobs”. Thus, a single administration delivering retinal peak levels of GAL-101 above threshold for <1 hour might have sustained detoxifying effect in dry AMD and glaucoma patients."

Galimedix Therapeutics Presents Data Showing Safety, Tolerability and Potential for Efficacy of Its Investigational Eyedrops Containing GAL-101 at Glaucoma 360 Conference (GlobeNewswire, Galimedix) - "Galimedix Therapeutics...presented an overview of data disclosed to date on its novel, first-in-class, investigational compound GAL-101, which, in animal models caused sustained prevention of misfolded amyloid beta molecules from aggregating into toxic forms in vitro, neutralizing their ability to be toxic to neural tissues. The presentation also included positive safety and tolerability data from the company’s Phase 1 study in both healthy and glaucoma patients. These data were presented at the Glaucoma 360 conference on February 1, 2019...These preclinical data, combined with a positive result in the Phase 1 study have made it possible for us to develop a Phase 2 program, for which we are currently in the planning and fundraising stage..."

New P2 trial • P1 data • Preclinical

Galimedix Therapeutics to participate in the 8th Annual Glaucoma 360 Conference (GlobeNewswire) - "Galimedix Therapeutics...announced its participation in the 8th Annual Glaucoma 360 New Horizons Forum being held on Friday, February 1, 2019 at the Palace Hotel in San Francisco. Chief Scientific Officer, Hermann Russ, M.D., Ph.D., will present previously disclosed data on the company’s compound, MRZ-99030/GAL-101 during the 1:22PM session titled, 'New Drugs and Drops.'"

Clinical data