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- Dimerix (ASX:DXB) secures approval from the Chinese NMPA Centre for Drug Evaluation (CDE) for its IND application
- The approval greenlights the recruitment of 70 clinical sites across 11 countries, with further expansion plans post the anticipated part-one analysis in March 2024
- IND approval signifies that no additional manufacturing, nonclinical, or clinical studies are necessary before enrolling Chinese patients in ACTION3
- The phase three study aims to enrol 286 FSGS patients globally, with a subset in mainland China
- DXB shares are up 10.7 per cent, trading at 15.5 cents at 12:48 pm AEDT
Dimerix (ASX:DXB) has secured approval from the Chinese National Medical Products Administration (NMPA) Centre for Drug Evaluation (CDE) for its Investigational New Drug (IND) application.
The approval greenlights the recruitment of 70 clinical sites across 11 countries, with further expansion plans post the anticipated part-one analysis in March 2024.
The IND approval signifies that no additional manufacturing, nonclinical, or clinical studies are necessary before enrolling Chinese patients in ACTION3.
“The NMPA approval is a milestone event that allows the ACTION3 study to commence enrolment in the world’s second-largest pharmaceutical market and provide a new clinical trial option for FSGS patients in China.” Dimerix Chief Medical Officer Dr David Fuller said.
“We are delighted that no bridging study in a Chinese population is required, which would allow the study to commence in China more efficiently after first analysis outcome. FSGS remains an area of high unmet medical need with no approved therapies for this indication.”
The phase three study aims to enrol 286 FSGS patients globally, with a subset in mainland China. Positive outcomes from ACTION3 could facilitate a future marketing authorisation application for DMX-200 in specific territories, including China.
Strategically designed with two interim analyses, the trial seeks to accumulate substantial evidence supporting marketing approval by assessing proteinuria and kidney function.
DXB shares were up 10.7 per cent, trading at 15.5 cents at 12:48 pm AEDT.
