Galimedix Therapeutics Completes Initial Dosing In Phase 1 Study Of GAL-101, An Oral Drug Modulating Amyloid Beta Aggregation

Galimedix Therapeutics, Inc., a Phase 2 clinical-stage biotechnology company focused on developing oral and topical neuroprotective therapies for serious brain and eye diseases, has announced the successful completion of the single ascending dose (SAD) portion of its ongoing Phase 1 clinical study of GAL-101. This investigational small molecule is designed to specifically target misfolded amyloid beta (Aβ) monomers, which are believed to play a critical role in neurodegenerative diseases.

In the SAD phase, 40 healthy volunteers were randomized in a 3:1 ratio to receive either GAL-101 capsules or a placebo. The study results showed that GAL-101 was well tolerated across all dose levels and exhibited a highly favorable safety profile. In addition, GAL-101 demonstrated an excellent pharmacokinetic profile, providing strong support for continued development using the oral route of administration. The ongoing Phase 1 trial is expected to enroll up to 120 participants in total. It is designed to generate the comprehensive safety, tolerability, and pharmacokinetic data needed to initiate planned oral Phase 2 studies in the company’s key target indications: Alzheimer’s disease, dry age-related macular degeneration (AMD), and glaucoma.

Hermann Russ, MD, PhD, Co-founder and Chief Scientific Officer of Galimedix, stated, 

 “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. 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.” 

In parallel with the oral program, Galimedix is also advancing its topical formulation of GAL-101. A Phase 2 clinical trial known as the eDREAM study is currently underway, evaluating GAL-101 eyedrops in patients with dry AMD. The company anticipates completing patient recruitment for this study within the next year. These developments mark an important step in Galimedix’s mission to bring forward novel neuroprotective treatments that address underlying disease mechanisms in both the central nervous system and the eye.