US-based biotechnology company Galimedix Therapeutics has completed the single ascending dose (SAD) portion of its Phase I trial of GAL-101, an orally administered small molecule designed to target misfolded amyloid beta (Aβ) monomers.
In the study’s SAD portion, 40 healthy volunteers were given either GAL-101 capsules or placebo capsules.
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The findings indicate that GAL-101 was tolerated well with a favourable safety profile, as well as a pharmacokinetic profile that supports the planned oral administration.
The ongoing Phase I trial is set to enrol up to 120 subjects to address all the necessary aspects to begin oral Phase II trials.
These studies will focus on indications such as Alzheimer’s disease, glaucoma, and dry age-related macular degeneration (AMD).
Further study arms, including a multiple ascending dose arm, are currently in progress and are anticipated to conclude towards the end of this year.
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By GlobalDataGalimedix Therapeutics’ chief scientific officer and co-founder Hermann Russ said: “The successful completion of the single ascending dose part of our Phase I 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 central nervous system, 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 addition to the oral formulation, Galimedix is conducting a Phase II clinical trial with GAL-101 eyedrops for dry AMD, which is due to complete recruitment within the next year.
According to the company, previous studies of GAL-101 eyedrops have also indicated a strong tolerability and safety profile.
