Humedix gets gov't OK for trials of dementia candidate drug

Jointly developed with G2G Bio and Korea Pharma, GB-5001 boasts treatment whose effects last for a month

Humedix gets gov't OK for trials of dementia candidate drug
In-Hyuk Park 1
2023-10-18 11:30:17 hyuk@hankyung.com
Bio & Pharma

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.

Write to In-Hyuk Park at hyuk@hankyung.com
#Humedix #dementia candidate drug #GB-5001 #Ministry of Food and Drug Safety #South Korea #clinical trials #G2GBio #Korea Pharma

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