Humedix gets gov't OK for trials of dementia candidate drug
In-Hyuk Park
Oct 18, 2023 (Gmt+09:00)
South Korea’s Humedix Co., a developer of biological and pharmaceutical products, on Tuesday said it received approval from the Ministry of Food and Drug Safety to hold clinical trials for its anti-dementia drug GB-5001.
For use in treating Alzheimer’s with the active ingredient donepezil, the candidate injection drug uses G2GBio’s platform technology Innovative Long-Acting MicroParticle, aka InnoLAMP.
Humedix is jointly developing the candidate drug, whose effects last for a month, with domestic partners Good to Globe Biotechnology (G2GBio) and Korea Pharma Co. Highly impressed with G2G Bio’s platform technology, Humedix made a strategic investment in the latter to obtain a stake.
With the green light for Phase 1 trials, the three companies will compare the safety, tolerance and pharmacokinetics of GB-5001 in formulations of subcutaneous and intramuscular injections with a control drug in healthy adults. Their target is commercial application after conducting Phase 2 trials and getting product approval.
Humedix, a strategic manufacturing partner for finished products, plans to produce and supply clinical and finished pharmaceuticals.