G2G Bio Confirms Safety of Once-Monthly Injectable Dementia Treatment in Phase 1 Trial

GB-5001: "Once-Monthly Injection of Donepezil for Daily Users"
Steady State Achieved Within 3–4 Doses After Four-Week Interval Administration
Stable Pharmacokinetic Profile Confirmed

G2G Bio, a drug delivery system (DDS) platform company, announced on August 27 that it has confirmed the safety and tolerability of its long-acting dementia treatment "GB-5001" in a Phase 1 clinical trial.

G2G Bio headquarters exterior view. G2G Bio

GB-5001 is a once-monthly long-acting injectable formulation with donepezil, a compound used to alleviate symptoms of Alzheimer's disease, as its main ingredient. It is being developed to address the inconvenience of daily oral administration required by existing drugs.

This Phase 1 clinical trial was conducted to evaluate the safety and tolerability of both single and multiple doses of GB-5001. No subjects withdrew due to serious adverse reactions or incidents during the administration period.

When 140mg of GB-5001 was administered at 4-week intervals, a steady state of drug concentration in the body was achieved after 3 to 4 doses. Compared to the control group, which received 5mg of the oral donepezil formulation “Aricept,” the mean steady-state concentration in blood (Cavg,ss) was similar, and the fluctuation between peak and trough concentrations was smaller, indicating more stable pharmacokinetic characteristics.

Professor Hong Janghee of Chungnam National University Hospital, who led this clinical trial, stated, "In addition to the good tolerability of GB-5001, we confirmed reliable pharmacokinetic properties—suppressed initial release and steady blood concentration maintained for over a month." He emphasized, "As the product is being developed with once-monthly administration in mind, we hope it will provide a treatment option that reduces medication burden and discomfort for patients and caregivers."

A G2G Bio official commented, "We have taken another step toward the commercial launch of GB-5001 through this clinical trial," and added, "We will prepare follow-up clinical trials without delay."

This content was produced with the assistance of AI translation services.