G2Gbio, “Initiates Phase 1 Clinical Trial in Canada” for GB-5001, a monthly sustained release Alzheimer's Treatment

G2Gbio, with its drug delivery platform technology, has announced that it conducted the first administration of GB-5001, an Alzheimer's treatment with a one-month extended-release efficacy, in Canada on the 26th.

GB-5001 is a sustained-release formulation utilizing donepezil, an existing dementia treatment compound. The initiation of this clinical trial in the North American region marks the world’s first for this extended-release formulation. 

According to the announcement, the Phase 1 clinical trial for GB-5001 in Canada aims to evaluate the safety, tolerability, and pharmacokinetics of a single dose of donepezil in 48 healthy male volunteers through a randomized, double-blind, placebo-controlled, dose-escalation study.

Conventional oral medications face difficulties in maintaining the appropriate drug dosage within the body due to swallowing difficulties or decreased memory compliance associated with dementia symptoms. In contrast, GB-5001 utilizes G2Gbio's InnoLAMP® technology to create controlled-release microspheres of consistent size, allowing for a regulated drug release rate. This is expected to reduce side effects (e.g., nausea, vomiting) associated with oral administration and enhance treatment compliance.

Shinwon Lee, Head of Clinical Trials, stated, "The successful initiation of the first clinical study for an InnoLAMP-based drug holds great significance for our company. We look forward to achieving successful clinical outcomes through close communication and collaboration with the local CRO (Contract Research Organization)."