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.

Start Date10 Jan 2025

Sponsor / Collaborator

Galimedix Therapeutics, Inc.

[+1]

NCT01714960

/ CompletedPhase 1

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.

Start Date01 Oct 2012

Sponsor / Collaborator

Merz Pharmaceuticals GmbH

100 Clinical Results associated with MRZ-99030

100 Translational Medicine associated with MRZ-99030

100 Patents (Medical) associated with MRZ-99030

Literatures (Medical) associated with MRZ-99030

07 Dec 2022·ACS chemical neuroscience

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

Article

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

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.

01 Nov 2020·NeuropharmacologyQ2 · MEDICINE

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

Q2 · MEDICINE

Article

Author: 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).

01 May 2015·NeuropharmacologyQ2 · MEDICINE

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

Q2 · MEDICINE

Article

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

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.

News (Medical) associated with MRZ-99030

12 Mar 2026

·www.biospace.com

Galimedix Therapeutics earns milestone payment in ophthalmology partnership with Théa Open Innovation

Kensington, MD, USA and Munich/Martinsried, Germany, March 12, 2026 (GLOBE NEWSWIRE) -- Galimedix Therapeutics earns milestone payment in ophthalmology partnership with Th é a Open Innovation Galimedix receives milestone payment for successful completion of Phase 1 trial with orally administered GAL-101 Phase 1 results show the compound to be clinically safe and well-tolerated, with a pharmacokinetic pro advancing to Phase 2 Payment provides Galimedix with an important operational runway to proceed with plans for additional clinical development in Alzheimer’s disease and other indications Kensington, MD, USA and Munich/Martinsried, Germany, March 12, 2026 – Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize and reshape the treatment of serious eye and brain diseases, today announced the achievement of a key milestone in its collaboration with Théa Open Innovation (“TOI”), a subsidiary of ophthalmic specialty pharmaceutical company, Laboratoires Théa. Galimedix has successfully completed the Phase 1 trial with orally administered GAL-101, which has triggered an undisclosed milestone payment to the Company. The eye drop formulation of GAL-101 is currently in Phase 2 development for the treatment of geographic atrophy, a severe form of dry age-related macular degeneration (AMD). “We are pleased with the achievement of this milestone for GAL-101,” said Céline Olmiere, Director of Théa Open Innovation. “This highly innovative drug candidate has the potential to significantly impact dry AMD patients who are at risk of going blind. Our collaboration with Galimedix supports continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists and their patients around the world.” “We are gratified to have the strong support of Théa Open Innovation in developing GAL-101 and excited to see such solid results in the Phase 1 trial,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman of Galimedix Therapeutics. “Importantly, this milestone payment provides Galimedix with significant operational runway and will allow us to advance our development plans for GAL-101 in Alzheimer’s disease and other supportive R&D work.” As previously announced, the Phase 1 results showed oral GAL-101 to be well tolerated and clinically safe, with an excellent pharmacokinetic profile, effectively crossing the blood-brain barrier, strongly supporting advancing the oral formulation in Phase 2 development in Alzheimer’s disease and other indications. In March 2023, TOI and Galimedix entered into a strategic partnership in ophthalmology for the development and commercialization of GAL-101 in Europe, the Americas, the Middle East and Africa. Under the terms of the agreement, Galimedix received an upfront technology access fee and is eligible to receive further success-based milestone payments as well as royalties on net sales. TOI is fully funding the remaining development of GAL-101 in dry AMD and will take charge of the registration and commercialization of the drug in ophthalmology. Galimedix is responsible for the conduct of the mid-stage clinical trials. TOI also made a direct investment into Galimedix, demonstrating its strong interest in the value of the Galimedix pipeline, including in Alzheimer’s disease. About GAL-101 GAL-101 is a small molecule targeting misfolded amyloid beta (Aβ) monomers and thus preventing the formation of toxic Aβ oligomers and protofibrils. It is being developed in both oral and topical (eye drops) formulations. Many studies have indicated that these Aβ aggregates are a major underlying cause of neurodegenerative diseases of the brain and retina, and recent approvals of anti-Aβ drugs have also validated them as a key target in Alzheimer’s disease. GAL-101 initially is being developed for the treatment of dry age-related macular degeneration (AMD), glaucoma, and Alzheimer’s disease. 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. In Phase 1 testing, both the oral and eye drop forms of GAL-101 demonstrated an excellent safety and tolerability profile. In addition, oral GAL-101 was shown to effectively cross the blood-brain barrier. The eDREAM Phase 2 study ( NCT06659549 ) in dry AMD/geographic atrophy with GAL-101 eye drops is ongoing. About Galimedix Therapeutics, Inc. Galimedix is a Phase 2 clinical-stage private biotechnology 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 Alzheimer’s disease, dry age-related macular degeneration and glaucoma, Galimedix’s initial areas of focus. For more information, please visit our website at and follow us on LinkedIn . About Théa and Théa Open Innovation Théa is the leading independent European pharmaceutical company specializing in the research, development, and commercialization of eye-care products. Based in Clermont-Ferrand, France, this family-owned company has continued to expand by opening more than 35 affiliates and offices in Europe, North Africa, North and South America, and the Middle East. Its products are available in 75 countries around the world. Théa Open Innovation, a subsidiary of Théa, is dedicated to set up partnerships with biotech/pharma companies and academic institutions to help bring the most innovative products in eye care to the market. To learn more, visit and . Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu Attachment 20260312_Galimedix_PR_Ph 1 Thea milestone CONTACT: Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu

Phase 1Phase 2Clinical ResultLicense out/in

05 Mar 2026

·www.biospace.com

Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD™ 2026 Conference

Kensington, MD, USA and Munich/Martinsried, Germany, March 05, 2026 (GLOBE NEWSWIRE) -- Galimedix Therapeutics to present promising pre-clinical data with next generation oral amyloid beta aggregation modulator at AD/PD ™ 2026 Conference Kensington, MD, USA, and Munich/Martinsried, Germany, March 05, 2026 – 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, will present pre-clinical data with a next-generation amyloid- (Aβ) aggregation modulator at the upcoming International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026). The conference will take place March 17 - 21, 2026 in Copenhagen, Denmark. The following poster will be presented: Title: New oral prodrug of the A β aggregation modulator GAL-201 shows significantly improved pharmacokinetic profile Poster number: #706; Board number: 02-480 Poster Session : Shift 2, March 20 – 21, 2026 Presenters: Katrin Riemann, Ph.D. and Hermann Russ, M.D. Ph.D., Galimedix Therapeutics The poster will discuss two prodrugs of GAL-201 and their oral bioavailability. International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders (AD/PD™ 2026) AD/PD™ 2026 provides a forum where leading international experts can gather to explore the latest research, clinical trials, and treatments for Alzheimer's and Parkinson's. The AD/PD™ Conference has grown to be one of the leading events in the field of neurodegenerative disorders with over 5,500 participants from more than 70 countries and over 2,500 abstracts in 2025. This year, the conference program will include forum discussions, symposia, as well as oral and poster presentations devoted to the latest breakthroughs in treatment, translational R&D, early diagnosis, drug development and clinical trials in AD, PD and other related neurological disorders. Galimedix is developing orally administered small molecules specifically designed to target misfolded Aβ and suppress the formation of soluble, toxic Aβ aggregates in the brains of people with Alzheimer’s disease. A Phase 1 study evaluating orally administered GAL-101, a first-in-class Aβ aggregation modulator, was recently completed and data demonstrated that GAL-101 was clinically safe and well tolerated and effectively crossed the blood-brain barrier. Target engagement could be shown in CSF and plasma. Phase 2 development in Alzheimer’s and other indications is planned. In addition, GAL-101 eye drops are being investigated in the Phase 2 eDREAM study in patients with geographic atrophy, a severe form of dry age-related macular degeneration, an A-associated retinal disease. 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 initial areas of focus. Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu Attachment 20260305_Press Release_Curtain_Raiser AD-PD2026 Conference CONTACT: Contact Alexander Gebauer, MD, PhD Galimedix Therapeutics, Inc. Co-founder and Executive Chairman info@galimedix.com Media inquiries: Anne Hennecke U.S. MC Services AG Laurie Doyle Tel: +49 (0)170 7134018 Tel: +1-339-832-0752 galimedix@mc-services.eu

Phase 2Phase 1

03 Dec 2025

·www.theaopeninnovation.com

Théa and Galimedix, Inc sign a new partnership

About us Our team News Laboratoires Théa Contact us About us Our team News Laboratoires Théa Contact us ©Eveon Home » News » Théa and Galimedix, Inc sign a new partnership Théa Open Innovation and Galimedix Therapeutics, Inc. announce strategic partnership to develop and commercialize GAL-101, a Phase 2/3-ready small molecule, to treat ophthalmic indications with high unmet medical need. “Through the partnership with Galimedix, Thea will be among the few companies globally that are working on an innovative drug for the treatment of dry AMD patients who are currently at risk of going blind,” said Jean-Frédéric Chibret, President of the Théa Group. “We are excited to be working with Galimedix, as this collaboration supports our continued commitment to building a strong cutting-edge and diversified ophthalmological portfolio for eye care specialists around the world and their patients.” Feel free to contact us to submit your project or ideas. By submitting this form, I accept that the information entered will be used, to answer my request. The recipient of the data is Théa. Please read our Privacy Policy Théa Open Innovation 12 rue Louis-Blériot 63017 CLERMONT-FERRAND cedex FRANCE Tel. +33 (0)4 73 98 14 36 About us Our team News Laboratoires Théa Contact us About us Our team News Laboratoires Théa Contact us © Théa Open Innovation 2024 | Personal data protection | Terms & conditions | Legal terms | Site Map

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100 Deals associated with MRZ-99030

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Geographic Atrophy	Phase 2	United States	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	Armenia	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	France	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	Germany	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	Ireland	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	Israel	Galimedix Therapeutics, Inc.	10 Jan 2025
Geographic Atrophy	Phase 2	Italy	Galimedix Therapeutics, Inc.	10 Jan 2025
Wet age-related macular degeneration	Phase 2	United States	Galimedix Therapeutics, Inc.	10 Jan 2025
Wet age-related macular degeneration	Phase 2	Armenia	Galimedix Therapeutics, Inc.	10 Jan 2025
Wet age-related macular degeneration	Phase 2	France	Galimedix Therapeutics, Inc.	10 Jan 2025

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


GlobeNewswire Manual	Phase 1	Alzheimer Disease	100	GAL-101	pqrodlexql(afddveixqp) = Consistent with pre-clinical findings, GAL-101 was shown to effectively cross the blood-brain barrier, and its pharmacokinetic (PK) profile strongly supports advancing the oral formulation in Phase 2 development in Alzheimer’s disease. The full study results are expected to be presented at a future scientific conference. trkpgopkvw (zutypdnslm ) View more	Positive	12 Sep 2025
ARVO2013	Phase 1	Glaucoma β-amyloid	-	MRZ-99030	svulgwnlrs(yozptyfuuf) = significantly decreased in drug-treated eyes hfozahgept (rlphkwygso )	Positive	01 Jun 2013

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