Galimedix Therapeutics Begins Phase 1 Clinical Trial for Oral GAL-101

Galimedix Therapeutics Inc. has announced the initiation of dosing in a Phase 1 clinical trial for oral GAL-101, an innovative amyloid beta (Aβ) aggregation modulator. The study aims to assess the therapy’s safety, tolerability, and pharmacokinetics, marking a significant step in its development for the treatment of Alzheimer’s disease, dry age-related macular degeneration (AMD), and glaucoma.

Phase 1 Trial Details

The trial will enroll up to 120 participants across two cohorts:

       • Single Ascending Dose (SAD): Up to 40 healthy volunteers.

       • Multiple Ascending Dose (MAD): 32 participants will receive repeated dosing.

Key objectives include evaluating the ability of GAL-101 to cross the blood-brain barrier and examining other pharmacokinetic parameters.

Alexander Gebauer, MD, PhD, co-founder and executive chairman of Galimedix Therapeutics, expressed optimism:
“GAL-101 eyedrops have already demonstrated excellent safety and efficacy in early clinical testing. We are eager to see the initial results of this Phase 1 trial, which will guide the development of our oral formulation for Alzheimer’s and future studies in dry AMD and glaucoma.”

About GAL-101

GAL-101 is a small molecule designed to target misfolded Aβ monomers, a critical step in preventing the formation of toxic Aβ oligomers and protofibrils. These toxic aggregates are implicated in neurodegenerative diseases, including Alzheimer’s disease and retinal conditions.

The compound is being developed in both oral and topical formulations (eyedrops), positioning it as a potential treatment for:

       • Alzheimer’s disease

       • Dry AMD

       • Glaucoma

Preclinical and Early Clinical Success

GAL-101 has demonstrated impressive results in both preclinical and early clinical studies:

Preclinical Findings:

       • Effectively prevents and eliminates toxic Aβ species while preserving healthy Aβ forms.

       • Demonstrated neuroprotective properties and symptomatic improvement in Alzheimer’s models.

       • Ophthalmic studies showed protection of neuronal retinal cells from toxic damage.

Phase 1 Eyedrop Studies:

       • Excellent safety and tolerability profile.

       • Compelling efficacy in relevant preclinical models for Alzheimer’s disease and ophthalmic conditions.

Oral Formulation Highlights:

       • No immunological side effects such as amyloid-related imaging abnormalities (ARIA).

       • Minimal systemic toxicity.

       • Cost-efficient manufacturing and robust storage stability.

Future Directions

Galimedix is advancing its clinical pipeline with pivotal studies on the horizon:

       • Phase 2 trial for GAL-101 eyedrops in dry AMD is set to begin recruitment soon (NCT06659549).

       • Results from the current Phase 1 trial of oral GAL-101 will inform next steps for Alzheimer’s disease and ophthalmic indications.

A Step Toward Transformative Treatments

With GAL-101 targeting the root cause of neurodegeneration linked to amyloid beta, Galimedix Therapeutics is poised to deliver innovative therapies for conditions that currently have limited treatment options. This milestone brings hope for patients facing devastating diseases like Alzheimer’s, dry AMD, and glaucoma.