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

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

Kensington, MD, USA and Munich/Martinsried, Germany, May 6, 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.

About GAL-101
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.

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  

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