Galimedix Therapeutics has concluded a Phase I trial of GAL-101, which showed that the therapy is safe and well tolerated without any serious adverse events identified.
The company is now preparing for a Phase II trial of the therapy for treating Alzheimer’s disease and has begun fundraising efforts.
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The Phase I study saw the enrolment of over 100 healthy volunteers to assess the tolerability, safety, and pharmacokinetics (PK) of GAL-101’s single-ascending doses (SAD) and multiple-ascending doses (MAD) and its blood-brain barrier crossing ability.
The therapy’s PK profile and ability to penetrate the blood-brain barrier were in line with pre-clinical findings.
Additionally, the study examined the therapy’s blood-brain barrier permeability and the influence of various factors such as food, gender, and age on its efficacy, notably critical data for the planned Phase II study in Alzheimer’s.
The complete results of the study are expected to be shared at a future scientific conference.
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By GlobalDataGalimedix is actively conducting a Phase II study with GAL-101 in eyedrop form for dry age-related macular degeneration (dAMD).
The eDREAM study is currently recruiting participants across the US, Europe, and other regions.
Notably, the development of the dAMD/geographic atrophy (GA) treatment is said to be funded by a partner, which helps reduce Galimedix’s financial risks.
Galimedix said that it is open to discussions regarding the latest data, investment, and collaborative opportunities with potential partners.
GAL-101, which targets misfolded amyloid beta (Aβ) monomers to prevent the formation of harmful Aβ oligomers and protofibrils, is under development in both oral and eyedrop formulations.
These Aβ aggregates have been identified as a significant factor in neurodegenerative conditions affecting the brain and retina.
Galimedix Therapeutics executive chairman and co-founder Alexander Gebauer said: “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 II trial in Alzheimer’s disease, an indication for which patients today have very limited treatment options.”
