Progress in clinical development for Alzheimer’s and other indications: Galimedix Therapeutics successfully completes Phase 1 study with oral small molecule, GAL-101, an amyloid beta aggregation modulator

• GAL-101 was well tolerated; excellent safety and pharmacokinetic profile strongly support oral administration
• GAL-101 effectively crosses the blood-brain barrier, supporting further development in Alzheimer’s disease
• A Phase 2 trial in Alzheimer’s disease is planned as the next step, fundraising has been initiated
  
  

KENSINGTON, Md. and MUNICH and MARTINSRIED, Germany, Sept. 12, 2025 (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 brain and retinal diseases, today announced the completion of its Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers. In the trial, GAL-101 was shown to be well tolerated and clinically safe, with no serious adverse events (SAEs) observed. 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.

“Completing our first clinical trial with the oral formulation of GAL-101 is an important milestone for Galimedix,” said Alexander Gebauer, MD, PhD, Co-founder and Executive Chairman of Galimedix. “We are pleased that the results showed that oral GAL-101 was well tolerated with a highly favorable safety profile. Additionally, the pharmacokinetic profile strongly supports the planned administration route, as well as continued development for the treatment of Alzheimer’s disease. We are planning a Phase 2 trial in Alzheimer’s disease, an indication for which patients today have very limited treatment options. GAL-101 is expected to be first-in-class and has the potential to become the future standard of care for all stages of Alzheimer’s, including mild cognitive impairment.”

The Phase 1 trial enrolled a total of over 100 healthy volunteers and evaluated the safety, tolerability and pharmacokinetics of single (SAD) and multiple (MAD) ascending oral doses of GAL-101. The study also evaluated GAL-101’s ability to cross the blood-brain barrier, as well as a variety of other parameters, including the effects of food, age and gender, all of the relevant aspects required to initiate Galimedix’s planned Phase 2 study in Alzheimer’s disease.

Galimedix is also conducting a Phase 2 clinical trial with GAL-101 eyedrops for dry age-related macular degeneration (dAMD); recruitment in the eDREAM study is ongoing in the US, Europe, and other regions. The development in dAMD/geographic atrophy (GA) is partner funded, mitigating the financial exposure of Galimedix.

Galimedix is prepared to discuss the available data and investment and partnering opportunities with interested parties.

Connect with Galimedix
To learn more, investors and partners are invited to connect with Galimedix management, who will attend the following fall conferences:

• LSX World Congress USA, Boston, MA, September 15-17
• 25^th Annual Biotech in Europe Forum, Basel, Switzerland, October 8-9
• BIO-Europe, Vienna, Austria, November 3-5
• LSX Inv€$tival, London, UK, November 17
  
  

To schedule a meeting or call, please reach out to info@galimedix.com.

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 brain and retina, 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 dAMD, 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 a previous Phase 1 study, GAL-101 eyedrops demonstrated an excellent safety and tolerability profile. The eDREAM Phase 2 study (NCT06659549) in dAMD/GA 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 brain and retinal 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 (dAMD) and glaucoma - 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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