Genexine anemia drug to start Phase 3 clinical trialsGenexine has won approval in Indonesia and Australia to start Phase 3 clinical trials for its treatment candidate for anemia patients with renal insufficiencies, the company said Tuesday.
The Kalbe Genexine Biologics joint venture, formed with Indonesia’s Kalbe Farma, is preparing to start a global Phase 3 study in six countries, including Indonesia and Australia, for GX-E4. The venture aims to track the efficacy and safety of GX-E4 on 386 patients over 52 weeks.
It is the first global study to be based in Indonesia, and it will be the first global study for a Genexine product.
The Korean firm completed the Phase 2 study for GX-E4 through a research program under the Ministry of Health and Welfare and transferred the technology to Kalbe Genexine Biologics to prepare the global study.
By Ko Jun-tae