Dimerix (ASX:DXB) has announced that Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an Investigational New Drug (IND) application to commence recruitment for ACTION3 Phase 3 study of DMX-200 for focal segmental glomerulosclerosis (FSGS) kidney disease.
The company said the study is recruiting across 70 clinical sites in 11 countries. It said it intends to open sites in additional countries, including China, following the part one analysis expected on or around 15 March 2024.
The full study will enrol 286 patients with FSGS globally, including some in mainland China. A subset of 144 patients (part two) enrolled in the study from all countries, including China, is to be incorporated in an interim analysis towards accelerated marketing Approval in regions where early access to medicines is possible.
“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," said Dimerix chief medical officer, Dr David Fuller.
"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. We look forward to reporting the outcome of the study’s first analysis in March 2024.”