• 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
  
  

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,  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.