A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.

开始日期2025-01-10

申办/合作机构

Galimedix Therapeutics, Inc.

[+1]

NCT01714960

/ Completed临床1期

Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

* To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2).
* To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

开始日期2012-10-01

申办/合作机构

Merz Pharmaceuticals GmbH

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项与 MRZ-99030 相关的文献（医药）

2022-12-07·ACS chemical neuroscience

Multiple Actions of H₂S-Releasing Peptides in Human β-Amyloid Expressing C. elegans

Article

作者: Ali, Rafat ; Nazir, Aamir ; Hameed, Rohil ; Sen, Shantanu ; Verma, Sandeep ; Wahajuddin, Muhammad ; Chauhan, Divya

Alzheimer's disease (AD) is a debilitating progressive neurodegenerative disorder characterized by the loss of cognitive function. A major challenge in treating this ailment fully is its multifactorial nature, as it is associated with effects like deposition of Aβ plaques, oxidative distress, inflammation of neuronal cells, and low levels of the neurotransmitter acetylcholine (ACh). In the present work, we demonstrate the design, synthesis, and biological activity of peptide conjugates by coupling a H₂S-releasing moiety to the peptides known for their Aβ antiaggregating properties. These conjugates release H₂S in a slow and sustained manner, due to the formation of self-assembled structures and delivered a significant amount of H₂S within Caenorhabditis elegans. These conjugates are shown to target multiple factors responsible for the progression of AD: notably, we observed reduction in oxidative distress, inhibition of Aβ aggregation, and significantly increased ACh levels in the C. elegans model expressing human Aβ.

2020-11-01·Neuropharmacology2区 · 医学

The Aβ aggregation modulator MRZ-99030 prevents and even reverses synaptotoxic effects of Aβ1-42 on LTP even following serial dilution to a 500:1 stoichiometric excess of Aβ1-42, suggesting a beneficial prion-like seeding mechanism

2区 · 医学

Article

作者: Parsons, Chris G ; Rammes, Gerhard

MRZ-99030 (GAL-101) is a small molecule that promotes the formation of off-pathway, non-toxic amorphous clusters of Aβ thereby reducing the amount of toxic soluble oligomeric Aβ species. MRZ-99030 clearly prevents synaptotoxic effects of Aβ_1-42 oligomers on synaptic plasticity and cognition. Long lasting in vivo effects indicate that MRZ-99030 seeds a beneficial self-replication of non-toxic Aβ aggregates - "trigger effect". To test this, we prepared a serial dilution of MRZ-99030 starting with a 20:1 stoichiometric excess to Aβ_1-42. After incubating the Aβ_1-42/MRZ-99030 mixture for 20 min, 10% was transferred to a freshly prepared Aβ_1-42 solution. This dilution step was repeated 3 times finally resulting in a 500:1 stoichiometric excess of Aβ_1-42 over MRZ-99030. This solution was tested for its ability to impair long-term potentiation (LTP) in CA1 neurons. Even following serial dilution, MRZ-99030 prevented the synaptotoxic effect of Aβ_1-42 on CA1-LTP after tetanic stimulation of the Schaffer collaterals whereas incubation with MRZ-99030 (0.1 nM) without serial dilution did not prevent the synaptic deficits caused by Aβ_1-42 (50 nM). Time course experiments revealed that this protective effect was still evident even when the serially diluted Aβ_1-42/MRZ-99030 mixture was prepared up to 1 week before the LTP experiment. MRZ-99030, when serially diluted with Aβ_1-42, 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_1-42 (10 μM).

2015-05-01·Neuropharmacology2区 · 医学

MRZ-99030 – A novel modulator of Aβ aggregation: II – Reversal of Aβ oligomer-induced deficits in long-term potentiation (LTP) and cognitive performance in rats and mice

2区 · 医学

Article

作者: Staniaszek, Lydia ; Sroka-Saidi, Kamila ; Jeggo, Ross ; Parsons, Christopher G ; Egger, Veronica ; Ruitenberg, Maarten ; Wegener, Nico ; Gravius, Andreas ; Kim, Eun-Mee ; Rammes, Gerhard ; Palmer, Philip ; O'Hare, Eugene ; Chambon, Caroline ; Bywalez, Wolfgang ; Spanswick, Dave

β-amyloid1-42 (Aβ1-42) is a major endogenous pathogen underlying the aetiology of Alzheimer's disease (AD). Recent evidence indicates that soluble Aβ oligomers, rather than plaques, are the major cause of synaptic dysfunction and neurodegeneration. Small molecules that suppress Aβ aggregation, reduce oligomer stability or promote off-pathway non-toxic oligomerization represent a promising alternative strategy for neuroprotection in AD. MRZ-99030 was recently identified as a dipeptide that modulates Aβ1-42 aggregation by triggering a non-amyloidogenic aggregation pathway, thereby reducing the amount of intermediate toxic soluble oligomeric Aβ species. The present study evaluated the relevance of these promising results with MRZ-99030 under pathophysiological conditions i.e. against the synaptotoxic effects of Aβ oligomers on hippocampal long term potentiation (LTP) and two different memory tasks. Aβ1-42 interferes with the glutamatergic system and with neuronal Ca(2+) signalling and abolishes the induction of LTP. Here we demonstrate that MRZ-99030 (100-500 nM) at a 10:1 stoichiometric excess to Aβ clearly reversed the synaptotoxic effects of Aβ1-42 oligomers on CA1-LTP in murine hippocampal slices. Co-application of MRZ-99030 also prevented the two-fold increase in resting Ca(2+) levels in pyramidal neuron dendrites and spines triggered by Aβ1-42 oligomers. In anaesthetized rats, pre-administration of MRZ-99030 (50 mg/kg s.c.) protected against deficits in hippocampal LTP following i.c.v. injection of oligomeric Aβ1-42. Furthermore, similar treatment significantly ameliorated cognitive deficits in an object recognition task and under an alternating lever cyclic ratio schedule after the i.c.v. application of Aβ1-42 and 7PA2 conditioned medium, respectively. Altogether, these results demonstrate the potential therapeutic benefit of MRZ-99030 in AD.

项与 MRZ-99030 相关的新闻（医药）

2025-05-08

·GlobeNewswire-Health Care

Galimedix Therapeutics completes single ascending dose part of Phase 1 study with oral small molecule, GAL-101, an amyloid beta aggregation modulator

GAL-101 well tolerated; excellent safety and pharmacokinetic profile strongly supports oral administration Next arms of study, including multiple ascending dose (MAD), underway and expected to complete in late 2025 Planned indications include dry age-related macular degeneration (AMD), glaucoma and Alzheimer’s disease May 06, 2025 -- Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious brain and eye diseases, today announced the completion of the single ascending dose (SAD) part of the Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers. In the SAD part of the study, a total of 40 healthy volunteers were randomized 3:1 to receive GAL-101 capsules or placebo capsules. The results showed that GAL-101 was well tolerated with a highly favorable safety profile. GAL-101 also demonstrated an excellent pharmacokinetic profile, strongly supporting the planned oral administration route. “The successful completion of the single ascending dose part of our Phase 1 trial with oral GAL-101 marks an important step forward in our clinical development,” said Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer of Galimedix. “The data we have seen so far support the safety, tolerability and pharmacokinetic profile we anticipated and reinforce the potential of GAL-101 as an oral therapy for CNS, eye and other diseases associated with amyloid beta pathology, including Alzheimer’s disease. We are proceeding according to plan and are now moving confidently into the next parts of the study, which we are on track to complete later this year.” The ongoing Phase 1 trial is designed to enroll up to 120 participants, addressing all relevant aspects required to initiate the planned oral Phase 2 studies in Galimedix´s key indications, namely Alzheimer’s disease, dry AMD and glaucoma. Galimedix also is conducting a Phase 2 clinical trial with GAL-101 eyedrops for dry AMD; the eDREAM study is expected to complete recruitment in less than a year from now. GAL-101 is a small molecule targeting misfolded Aβ monomers and thus preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eyedrops) formulations. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the eye, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease. GAL-101 is being developed for the treatment of dry AMD, glaucoma and Alzheimer’s disease. In a previous Phase 1 study, GAL-101 eyedrops demonstrated an excellent safety and tolerability profile. In pre-clinical testing, the compound has been shown to prevent and eliminate all forms of toxic Aβ species while leaving healthy Aβ forms intact. GAL-101 has also demonstrated the potential for neuroprotection and for symptomatic alleviation in pre-clinical models of Alzheimer’s disease. Additionally, orally available GAL-101 has shown no antibody-specific immunological side effects (e.g., ARIA), very low systemic toxicity, robust storage stability, and easy and inexpensive manufacturing. Strong efficacy has also been demonstrated in relevant ophthalmic pre-clinical models, protecting neuronal retinal cells from toxic damage. A Phase 2 study (NCT06659549) in dry AMD with GAL-101 eyedrops is ongoing. Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives and scientists, Galimedix’s groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry age-related macular degeneration (AMD), glaucoma and Alzheimer’s disease - Galimedix’s initial areas of focus. The content above comes from the network. if any infringement, please contact us to modify.

临床结果

2025-01-23

·PRNewswire

70+ Key Companies Advancing in Dry Age-Related Macular Degeneration Clinical Trial Therapeutic Space | DelveInsight

Dry macular degeneration is a common eye disorder among people aged above 50 years. It causes blurred or reduced central vision due to thinning of the macula. The macula is the part of the retina responsible for clear vision in a direct line of sight. The pharmaceutical industry is increasingly focused on developing pathway-based therapies for dry AMD, with promising treatments like ALK-001 and LBS-008 in trials, though a combination approach may be needed to fully inhibit disease progression. LAS VEGAS, Jan. 23, 2025 /PRNewswire/ -- DelveInsight's ' Dry Age-Related Macular Degeneration Pipeline Insight 2025 ' report provides comprehensive global coverage of pipeline dry AMD therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the dry AMD pipeline domain. Key Takeaways from the Dry Age-Related Macular Degeneration Pipeline Report DelveInsight's dry AMD pipeline report depicts a robust space with 70+ active players working to develop 80+ pipeline therapies for dry AMD treatment. Key dry AMD companies such as Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others are evaluating new dry AMD drugs to improve the treatment landscape. Promising dry AMD pipeline therapies such as ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others are under different phases of dry AMD clinical trials. In December 2024, Galimedix Therapeutics announced the initiation of its Phase II eDREAM study to assess the safety and efficacy of GAL-101 eye drops in patients with dry age-related macular degeneration. In December 2024, Ocugen, Inc. announced that the Data and Safety Monitoring Board (DSMB) for the OCU410 ArMaDa clinical trial recently convened and approved continuation of the second phase of the Phase 1/2 study. OCU410 (AAV5-hRORA) is a novel modifier gene therapy candidate being developed for geographic atrophy (GA) secondary to dry age-related macular degeneration (dAMD). In November 2024, Ocugen, Inc. announced positive preliminary efficacy and safety data from the Phase I dose-escalation portion of the Phase 1/2 OCU410 ArMaDa clinical trial for geographic atrophy (GA), secondary to dry age-related macular degeneration (dAMD). Key findings include: no drug-related serious adverse events, reduced lesion growth, preservation of retinal tissue, and most importantly there was a positive effect on the functional visual measure of low luminance visual acuity (LLVA). In October 2024, Eyestem Research, focused on creating scalable cell therapies for incurable diseases, had announced a positive outcome of the Drug Safety Monitoring Board (DSMB) review for the first cohort of its Phase one trial to treat Geographic Atrophy secondary to Dry Age-related Macular Degeneration, marking a milestone for Indian science and medical research. In September 2024, Stealth BioTherapeutics Inc. announced the presentation of new bevemipretide (SBT-272) preclinical data demonstrating topical ocular delivery to the retina with protective effects observed in models of AMD. In June 2024, Stealth BioTherapeutics Inc. announced that it has enrolled and dosed its first patient in the ReNEW trial as part of its Phase III clinical program for elamipretide in patients with dry age-related macular degeneration (dry AMD). The program consists of the two Phase III trials, ReNEW and ReGAIN. Both trials will evaluate the efficacy, safety, and pharmacokinetics of daily subcutaneous injections of elamipretide in participants with dry AMD. In April 2024, Eyestem received approval from India's Central Drugs Standards Control Organisation (CDSCO) to commence human trials for Eyecyte RPE, a potential treatment for geographic atrophy arising from dry age-related macular degeneration (AMD). Request a sample and discover the recent advances in dry AMD treatment drugs @ Dry Age-Related Macular Degeneration Pipeline Report The dry AMD pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage dry AMD drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the dry AMD clinical trial landscape. Dry Age-Related Macular Degeneration Overview Age-related macular degeneration (AMD) is one of the top four causes of blindness in older adults and the leading cause of irreversible blindness in developed countries. Around 170 million people globally are affected by AMD, making it the third most common cause of vision loss worldwide. Dry AMD typically progresses slowly, but wet AMD can cause severe visual impairment within days or weeks of onset. In the early stages of AMD, there are no noticeable symptoms, though an ophthalmologist can detect drusen before symptoms arise. Some individuals experience slight vision changes during the intermediate stage, but many remain symptom-free. Others may notice dark or grey spots in their central vision or have difficulty transitioning from bright to dim lighting. Clinicians currently use various imaging techniques to monitor changes in the retina, retinal pigment epithelium (RPE), and choroid, including fundus exams, color fundus photography, fundus autofluorescence (FAF), optical coherence tomography (OCT), and infrared reflectance imaging. Over the past two decades, OCT has significantly advanced the early detection, monitoring, and treatment assessment of dry AMD. Modern spectral-domain OCT (SD-OCT) systems provide detailed cross-sectional and volumetric views of the retina, enabling clinicians to visualize, measure, and monitor retinal layers, RPE, hyperreflective foci, geographic atrophy (GA), and drusen. While SD-OCT remains the standard of care, emerging technologies like polarization-sensitive OCT (PS-OCT), which offers tissue-selective imaging, may revolutionize AMD research and clinical practices. Currently, no approved treatments exist for dry AMD. Management involves regular monitoring, timely detection of visual deterioration, appropriate rehabilitation, and early identification of choroidal neovascularization (CNV). Research is underway to explore therapeutic strategies to prevent AMD, slow its progression, or restore vision. Potential treatments include lifestyle and behavioral changes, age-related eye disease study (AREDS) supplements, visual cycle modulators, anti-inflammatory agents, complement inhibitors, gene therapy, cell-based therapies, and approaches to reduce toxic by-products. Find out more about dry AMD treatment drugs @ Drugs for Dry Age-Related Macular Degeneration Treatment A snapshot of the Dry Age-Related Macular Degeneration Pipeline Drugs mentioned in the report: Learn more about the emerging dry AMD pipeline therapies @ Dry Age-Related Macular Degeneration Clinical Trials Dry Age-Related Macular Degeneration Therapeutics Assessment The dry AMD pipeline report proffers an integral view of the dry AMD emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Dry Age-Related Macular Degeneration Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Dimerisation inhibitors, Vitamin A replacements, RBP4 protein inhibitors, Sigma-2 receptor antagonists, Complement factor H stimulants, Macrophage inhibitors, Cell replacements, RNA interference, Key Dry Age-Related Macular Degeneration Companies: Alkeus Pharmaceuticals, Dobecure, Belite Bio, Cognition Therapeutics, Aviceda Therapeutics, Stealth BioTherapeutics, Allergo Ophthalmics, Annexon, Inc., Johnson & Johnson, InflammX Therapeutics, Lineage Cell Therapeutics, Ionis Pharmaceuticals, Evergreen Therapeutics, Inc., Alexion, Luxa Biotechnology, Astellas Pharma, OliX Pharmaceuticals, Hoffmann-La Roche, Boehringer Ingelheim, Eyevensys and others Key Dry Age-Related Macular Degeneration Pipeline Therapies: ALK-001, Etamsylate, Tinlarebant (LBS-008), CT1812, AVD-104, Elamipretide, Risuteganib, ANX 007, JNJ 81201887, Xiflam, OpRegen, IONIS-FB-LRx, EG-301, ALXN2040, RPESC-RPE-4W, MA09-hRPE, OLX301A, RO7303359, BI 771716, EYS 611 and others. Dive deep into rich insights for new drugs for dry AMD treatment, visit @ Dry Age-Related Macular Degeneration Drugs Table of Contents For further information on the dry AMD pipeline therapeutics, reach out @ Dry Age-Related Macular Degeneration Treatment Drugs Related Reports Dry Age-Related Macular Degeneration Market Dry Age-Related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key dry AMD companies including Alkeus Pharmaceuticals, Belite Bio, Aviceda Therapeutics, Johnson & Johnson Innovative Medicine, Allegro Ophthalmics, Lineage Cell Therapeutics (CellCure Neurosciences), Roche, Cognition Therapeutics, Stealth BioTherapeutics, Evergreen Therapeutics, Annexon Biosciences, NGM Biopharmaceuticals, AstraZeneca, Alexion Pharmaceuticals, Ionis Pharmaceuticals, Novartis, Regenerative Patch Technologies, among others. Dry Age-related Macular Degeneration Epidemiology Forecast Dry Age-related Macular Degeneration Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted dry AMD epidemiology in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. Age-related Macular Degeneration Market Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key AMD companies including Regeneron Pharmaceuticals, Novartis, Roche, Opthea Limited, Kodiak Sciences Inc., REGENXBIO, Alkahest Inc, Graybug Vision, Ribomic USA Inc, Outlook Therapeutics, Inc., Unity Biotechnology, Inc, PanOptica, Inc., Clearside Biomedical, Alexion Pharmaceuticals, AstraZeneca, Evergreen Therapeutics, Alkeus Pharmaceuticals, Stealth BioTherapeutics, CellCure Neurosciences, Regenerative Patch Technologies, Allegro Ophthalmics, Annexon Biosciences, NGM Biopharmaceuticals, Ionis Pharmaceuticals, Apellis Pharmaceuticals, Iveric Bio, Gyroscope Therapeutics, Luxa Biotechnology, Gemini Therapeutics , among others. Wet Age-related Macular Degeneration Market Wet Age-related Macular Degeneration Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Wet Age-related Macular Degeneration companies including EyePoint Pharmaceuticals, Inc., AbbVie, Caregen Co. Ltd., Exegenesis Bio, Shanghai Henlius Biotech, Skyline Therapeutics, 4D Molecular Therapeutics, Ocugenix Corporation, Adverum Biotechnologies, Inc., Ashvattha Therapeutics, Inc., AiViva BioPharma, Inc., Ocular Therapeutix, Inc., Clearside Biomedical, Inc., Hoffmann-La Roche, Kyowa Kirin, Inc., Opthea Limited, AffaMed Therapeutics Limited, EyeBiotech Ltd., Novartis , among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床3期临床2期

2024-06-10

·BioSpace

Galimedix Therapeutics Establishes Scientific Advisory Board of Renowned Retina Experts as Company Prepares to Enter Phase 2 Clinical Study with GAL-101

Board consists of key opinion leaders from both clinical practice and academia with strong track records in the development of ophthalmic compounds Galimedix is well positioned for the next phase of development of GAL-101 eye drops in dry AMD, addressing a major medical need in ophthalmology Scientific Advisory Board meeting was held to discuss Phase 2 DREAM trial, which is expected to initiate in late 2024 KENSINGTON, MD / ACCESSWIRE / June 10, 2024 Galimedix Therapeutics, Inc. ("Galimedix"), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases, has formed a Scientific Advisory Board (SAB). The SAB has been established to provide advice and direction to the Company for the development of its compound GAL-101 for the treatment of dry age-related macular degeneration (AMD), an indication with high unmet medical need. The SAB consists of retina experts with deep knowledge and experience from both clinical practice and academia with strong track records in the development of ophthalmic drugs. The advisors will consult with the Company as it advances lead compound, GAL-101, as a potential eye drop treatment for dry AMD, one of the leading causes of blindness. Scientific advisors include: Konstantinos Balaskas, MD, UCL Institute of Ophthalmology, London, UK Justis P. Ehlers, MD, Cole Eye Institute Cleveland Clinic, Cleveland, OH, USA Jeffrey S. Heier, MD, Ophthalmic Consultants of Boston, Boston, MA, USA Peter K. Kaiser, MD, Cole Eye Institute Cleveland Clinic, Cleveland, OH, USA Eleonora Lad, MD, PhD, Duke University Medical Center, Durham, NC, USA Ursula Schmidt-Erfurth, MD, Medical University of Vienna, Vienna, Austria Omer Trivizki, MD, MBA, Tel-Aviv Medical Center, Tel-Aviv, Israel. "We are excited to have such an esteemed group of international experts join our Scientific Advisory Board," said Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer of Galimedix. "The results our lead compound GAL-101 has shown in preclinical studies and in clinical Phase 1 are encouraging and as we continue to move forward in advancing this drug candidate in the field of ophthalmology, the knowledge and expertise this group brings to Galimedix will be invaluable." A SAB meeting was held during the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, WA, USA on May 4th, 2024. The Company and the SAB agreed on the design, endpoints and selection criteria of the upcoming Phase 2 DREAM study, which is expected to begin in late 2024. About Galimedix Therapeutics, Inc. Galimedix is a Phase 2 clinical-stage private company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious eye and brain diseases. Founded by a seasoned and highly dedicated team of bio-entrepreneurs, pharmaceutical executives, and scientists, Galimedix's groundbreaking small molecules offer the hope of changing the course of disease where amyloid beta (Aβ) plays a role, such as in dry age-related macular degeneration (AMD), glaucoma and Alzheimer's disease - Galimedix's areas of focus. About GAL-101 The Company's approach targets toxic Aβ oligomers and protofibrils. Many studies have indicated that these oligomers and protofibrils are a major underlying cause of neurodegenerative diseases of the eye. Recent approvals and promising Phase 3 results of anti-Aβ drugs also have validated them as a key target in Alzheimer's disease. Compelling pre-clinical data support the potential of Galimedix's drug candidates to slow or stop neurodegeneration and restore lost neuronal function. A Phase 2 proof-of-concept study in dry AMD with lead program, topical GAL-101, is in preparation with strong support from partner, Théa Open Innovation (TOI). Clinical studies in other indications are planned. Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke / Vera Lang U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu SOURCE: Galimedix Therapeutics, Inc. View the original press release on accesswire.com

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适应症	最高研发状态	国家/地区	公司	日期
地图样萎缩	临床2期	美国	Galimedix Therapeutics, Inc.	2025-01-10
湿性年龄相关性黄斑变性	临床2期	美国	Galimedix Therapeutics, Inc.	2025-01-10
干性年龄相关性黄斑病变	临床2期	美国	Thea Open Innovation SAS	2023-03-29
干性年龄相关性黄斑病变	临床2期	欧盟	Thea Open Innovation SAS	2023-03-29
青光眼	临床2期	美国	GALIMEDIX THERAPEUTICS, INC	2022-01-30
阿尔茨海默症	临床前	德国	Merz Pharmaceuticals GmbH	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ARVO Annual Meeting 2019 (ARVO2019)	N/A	干性年龄相关性黄斑病变 \| 青光眼 Aβ deposits	-	GAL-101 eye drops	醖鏇膚齋鹹餘壓衊積顧(襯顧糧餘鹹遞艱鏇鹹鬱) = 願簾願鹹壓蓋鬱艱糧構膚顧醖艱襯糧鹽夢衊鏇 (齋餘積願夢襯製選繭壓 ) 更多	积极	2019-07-01
ARVO2013	临床1期	青光眼 β-amyloid	-	MRZ-99030	遞構積窪製積壓鹽鬱選(網鏇夢觸構積製淵窪衊) = significantly decreased in drug-treated eyes 艱顧餘糧願憲鹹鏇顧糧 (糧壓夢選鹹獵壓艱遞艱 )	积极	2013-06-01