Galimedix Therapeutics, Inc. has 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, co-founder and executive chairman of Galimedix.
“We are pleased that the results showed that oral GAL-101 was well tolerated with a highly favourable 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 more than 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. Fife Council approves ambitious Active Travel Strategy
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