G2Gbio (456160) said it has confirmed the safety and tolerability of GB-5001, a long-acting dementia treatment administered once a month, in a Phase 1 clinical trial.
The company said in a regulatory filing on the 27th that it had received a draft clinical study report (CSR) for the Phase 1 trial of GB-5001.
GB-5001 is a once-monthly long-acting injection whose main ingredient is donepezil, a drug widely used to ease symptoms of Alzheimer's disease. It is being developed to improve on the inconvenience of existing oral drugs that must be taken daily, making treatment easier for dementia patients who have difficulty swallowing pills or tend to miss doses.
The Phase 1 trial was designed to evaluate the safety and tolerability of GB-5001 after single and repeated administration. No serious adverse events occurred during the dosing period, and no participants dropped out because of adverse events.
The trial also confirmed the drug's pharmacokinetic profile. When 140 milligrams of GB-5001 was administered repeatedly at four-week intervals, blood concentrations of the drug reached a steady state — a stable level in the body — within three to four doses.
Average blood concentration at steady state was similar to that of the control group, which received 5 milligrams of Aricept, an oral donepezil treatment. The gap between peak and trough concentrations was smaller, confirming the pharmacokinetic stability of GB-5001.
Hong Jang-hee, a professor at Chungnam National University Hospital who led the trial, said the drug showed good tolerability along with pharmacokinetic characteristics that suppressed initial release and maintained a consistent blood concentration for more than a month. "Since it is being developed with once-monthly dosing as the goal, we hope it can become a treatment option that reduces the dosing burden and inconvenience for patients and caregivers," the professor said.
