바이오스펙테이터

by Sungmin Kim

G2GBIO, a Korean biotech with a proprietary drug delivery system (DDS) platform technology, announced today that Health Canada has approved the phase 1 clinical trial of ‘GB-5001’, a monthly injectable dementia treatment.

The clinical study, which will be conducted in Toronto, Canada, is designed to investigate dose-dependent pharmacokinetics of GB-5001 in 48 healthy participants compared to the original drug, Aricept (Donepezil). G2GBio plans to start administering to patients in the phase 1 clinical trial as early as the end of this year.

G2GBIO has been developing a monthly injectable treatment for dementia using Donepezil since 2017. The long-acting Donepezil is designed to achieve the comparable efficacy to existing drugs which require daily administration. Dementia patients often have difficulty remembering to take their medication and also struggle to take it orally. Eventually, the poor patient compliance worsens disease symptoms. For these reasons, the need to develop sustained-release formulation has been constantly raised and G2GBIO is devoting considerable resources to its effort on fulfilling the unmet medical needs.

President Hee-yong Lee stated, “the development difficulty for a monthly injectable Donepezil is quite high for a few reasons. First, the mass production of this long-acting drug is challenging as its injection dosage is higher compared to other long-acting injectables; and second, it is difficult to secure competitive manufacturing cost. However, I expect that the recent approval of phase I clinical trial in Canada and GMP production data will expedite the ongoing licensing discussions with about 50 local and global companies.

On the other hand, G2GBIO has its own proprietary DDS platform namely, ‘Innovative Long-Acting MicroParticle (InnoLAMP)’ technology. Using this technology, G2GBIO is developing a monthly injectable Rivastigmine, another incrementally modified drugs (IMD) for dementia, in addition to the long-acting Donepezil, which also has been applied for overseas clinical trial. Furthermore, the Korean biotech plans to conduct clinical trials with its other pipelines including a weekly injectable post-operative pain drug, a monthly injectable anti-diabetic agent and 6-monthly injectable anti-osteoarthritis drug within the next 1-2 years.