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 Date16 Dec 2024

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

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: Rammes, Gerhard ; Parsons, Chris G

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: I – Mechanism of action (MoA) underlying the potential neuroprotective treatment of Alzheimer's disease, glaucoma and age-related macular degeneration (AMD)

Q2 · MEDICINE

Article

Author: Rammes, Gerhard ; Ruitenberg, Maarten ; Sroka-Saidi, Kamila ; Parsons, Christopher G ; Freitag, Christine E ; Russ, Hermann

Therapeutic approaches addressing β-amyloid1-42 (Aβ1-42) aggregation represent a promising neuroprotective strategy for the treatment of Alzheimer's disease, dry age-related macular degeneration (AMD) and glaucoma. MRZ-99030 is a dipeptide containing d-tryptophan and 2-amino-2-methylpropionic acid in clinical development for the topical treatment of glaucoma and AMD. MRZ-99030 is an Aβ aggregation modulator, previously reported to prevent the formation of soluble toxic oligomeric Aβ species. The present study confirmed that MRZ-99030 prevents the formation of oligomeric Aβ species using similar SDS-PAGE experiments. However, additional data from TR-FRET, DLS and AFM experiments revealed that MRZ-99030 does not directly prevent early protein/protein interactions between monomeric Aβ, but rather promotes the formation of large, non-amyloidogenic, amorphous Aβ aggregates and thereby reduces the amount of intermediate toxic soluble oligomeric Aβ species. The affinity of MRZ-99030 to Aβ1-42 determined by SPR was 28.4 nM but the ratio of compound to Aβ is also important: a 10-20 fold excess of MRZ-99030 over Aβ is probably required for effective modulation of protein/protein interactions. For example, in glaucoma, assuming a maximal Aβ concentration of 1-15 nM in the retina, up to 150 nM MRZ-99030 could be required at the protein target. In line with this consideration, MRZ-99030 was able to prevent Aβ-induced toxicity on PC12 cells, retinal ganglion cells and retinal pigment epithelium cells when present at a 10-20 fold stoichiometric excess over Aβ. Moreover, in vivo studies demonstrate the neuroprotective potential of MRZ-99030 after systemic and topical administration in animal models of Alzheimer's disease and glaucoma/AMD respectively.

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

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

10 Jun 2024

·www.biospace.com

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

Phase 2Phase 3

08 Mar 2024

·www.globenewswire.com

Galimedix Therapeutics presents new scientific data showing promising neuroprotective effects of GAL-201 for the treatment of Alzheimer’s disease at AD/PD™ 2024

GAL-201 specifically targets and binds to misfolded Aβ monomers, preventing their aggregation to toxic Aβ oligomers and protofibrilsAs a consequence, consistent beneficial effects have been demonstrated on synaptic spine density and on cognitive performance after single injection of GAL-201 in transgenic models of Alzheimer’s diseaseThese results warrant initiation of an IND-enabling program as next step towards clinical development KENSINGTON, Md., March 08, 2024 (GLOBE NEWSWIRE) -- 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, announces encouraging data with orally available small molecule GAL-201, showing its neuroprotective and symptomatic alleviation potential in models of Alzheimer’s disease (AD). These new findings strongly support previous studies where GAL-201 was characterized as a promising development candidate for the treatment of AD (Russ et. al. 2022). The data was presented this week at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD™ 2024: advances in science and therapy). “The small molecule GAL-201 belongs to a new pharmacological class of amyloid beta aggregation modulators that acts upstream of other known Aβ-targeting agents,” explained Hermann Russ, M.D., Ph.D., Co-founder, and Chief Scientific Officer of Galimedix. “The positive results presented at AD/PD™ 2024 demonstrate how treatment with GAL-201 has a potential neuroprotective effect and may also improve cognitive function. Furthermore, they validate that toxic Aβ oligomers and protofibrils are a major underlying cause of this devastating disease, and not the deposited forms of Aβ. We look forward to advancing this promising new drug candidate into the clinic.” Data from the poster, entitled “The amyloid beta aggregation modulator GAL-201 is under development for oral AD treatment: Cognitive improvement in a transgenic AD model”, showed a high affinity of GAL-201 to misfolded Aβ monomers, the precursors of the neurotoxic forms of Aβ oligomers and protofibrils. Binding of GAL-201 to the Aβ monomers significantly prevented Aβ-induced suppression of long-term potentiation (LTP), considered a neuronal correlate of learning and memory. These results mirrored morphological changes observed in neuronal cells (dendrites), where Aβ-induced spine loss was also prevented. Preserving dendritic spines is essential, as they are correlated with synaptic plasticity. Additionally, in behavioral experiments using AD animal models, a single injection of GAL-201 resulted in improved cognitive performance, both in duration (escape latency) and accuracy (left and right decisions) performing a task (water-cross maze) and were comparable to healthy mice. The presented results further substantiate GAL-201’s role as a promising future Aβ-targeting treatment for AD, with an advanced mechanism of action and a patient-friendly application route as an oral tablet. The next step is to move GAL-201 towards IND submission and clinical development. The poster can be accessed here: “The amyloid beta aggregation modulator GAL-201 is under development for oral AD treatment: Cognitive improvement in a transgenic AD model” About GAL-201GAL-201 is an orally administered small molecule specifically designed to target amyloid beta (Aβ) and suppress the formation of toxic forms of Aβ aggregates in the brain of people with AD. GAL-201 has been shown to be able to bind with high affinity to the misfolded forms of Aβ, and thereby prevent their aggregation to toxic Aβ oligomers and protofibrils. GAL-201 is believed to be a promising development candidate for the treatment of AD with the potential to slow or stop disease progression and is currently in pre-clinical testing. Galimedix holds global rights to GAL-201. 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 diseases 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 Company’s approach targets toxic Aβ oligomers and protofibrils. Many studies have indicated that these oligomers and protofibrils are an 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 product 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 / Lydia Robinson-GarciaU.S.MC Services AGLaurie DoyleTel: +49 (0)170 7134018Tel: +1-339-832-0752galimedix@mc-services.eu

Phase 2Clinical ResultPhase 3

25 Oct 2023

·www.biospace.com

Galimedix Appoints Dr. Luciana Summo as Vice President, R&D Operations

Brings over 20 years of clinical experience, including management of Phase 1-2 clinical trials in a variety of indications such as ophthalmology Will oversee all R&D operations with focus on clinical development and operations KENSINGTON, MD / ACCESSWIRE / October 25, 2023 / 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, today announced the appointment of Luciana Summo, PhD, as Vice President, R&D Operations. In this newly created position, she will oversee all activities related to R&D operations, with an emphasis on clinical development and operations. This includes spearheading the design, planning, and execution of clinical trials. Dr. Summo reports to Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer. "We are delighted to welcome Luciana to Galimedix," said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman . "She brings strong experience setting up and running clinical trials and ensuring that all of the proper support structures are put in place. As we move our lead product candidate, GAL-101, into Phase 2 testing for the treatment of dry age-related macular degeneration, her skill set is the perfect fit for this next stage in our development. Luciana will play a pivotal role in defining Galimedix's overall R&D strategy and driving our R&D initiatives forward. All of us very much look forward to working with her as we contribute to advancing innovative healthcare solutions that have the potential to improve the lives of patients." Dr. Summo has over 20 years of experience in clinical development and operations, including the management of Phase 1-2 clinical trials in several indications such as ophthalmology, cardiology, and oncology. Prior to joining Galimedix, she worked in positions of increasing responsibility in the clinical departments at OMEICOS Therapeutics GmbH, NOXXON Pharma AG, and Berlin-Chemie AG/ Menarini Group. She is well versed in setting up and overseeing clinical trials on a global scale and has played a key role in transitioning programs from pre-clinical to clinical stage. She has experience with the entire spectrum of activities related to R&D operations, with a special emphasis on clinical development and clinical operations, including also quality management and CMC. She works closely with cross-functional teams, including CROs, scientists, clinicians, regulatory affairs specialists, and different stakeholders, to ensure that trials are conducted in accordance with rigorous scientific standards and regulatory guidelines. Dr. Summo has experience in submitting Clinical Trial Applications (CTAs) in Europe and Investigational New Drug (IND) applications in the US and prepared for and participated in pre-IND meetings with the US Food and Drug Administration (FDA), as well as regulatory agency meetings in Europe. She also has set up from scratch and run a clinical operations department. Luciana Summo, PhD, Vice President, R&D Operations , added: "I am truly excited to be joining Galimedix at this important point in the Company's growth. The programs in ophthalmology and Alzheimer's disease have the potential to change the treatment paradigm, and I look forward to working with the rest of the team to bring them forward in the clinic." 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. The Company's approach targets toxic Aβ oligomers and protofibrils. Many studies have indicated that these oligomers and protofibrils are an underlying cause of neurodegenerative diseases of the eye. And, 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 product candidates to slow or stop neurodegeneration and also 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 / Lydia Robinson-Garcia 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 source version on accesswire.com:

Phase 2Executive ChangePhase 3

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	-	Galimedix Therapeutics, Inc.	16 Dec 2024
Wet age-related macular degeneration	Phase 2	-	Galimedix Therapeutics, Inc.	16 Dec 2024
dry age-related macular degeneration	Phase 2	US	Thea Open Innovation SAS	29 Mar 2023
dry age-related macular degeneration	Phase 2	EU	Thea Open Innovation SAS	29 Mar 2023
Glaucoma	Phase 2	US	GALIMEDIX THERAPEUTICS, INCStartup	30 Jan 2022
Alzheimer Disease	Phase 1	DE	Merz Pharmaceuticals GmbH	-

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO Annual Meeting 2019 (ARVO2019)	Not Applicable	dry age-related macular degeneration \| Glaucoma Aβ deposits	-	GAL-101 eye drops	(szxzqnqvgj) = almriucjxb jrrgxcrolf (jlkevkehhc ) View more	Positive	01 Jul 2019
ARVO2013	Phase 1	Glaucoma β-amyloid	-	MRZ-99030	bufslzbbqz(vgzxqunirm) = significantly decreased in drug-treated eyes lyxmtjkuys (xrprplvahe )	Positive	01 Jun 2013

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