Dimerix receives MHRA approval for paediatric investigation plan

Dimerix Limited (ASX: $DXB) has received approval from the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) for its Paediatric Investigation Plan (PIP) for the development of DMX-200 for focal segmental glomerulosclerosis (FSGS). The approval allows the inclusion of children aged 12-17 in the Company's ACTION Phase 3 study in the UK, marking a significant step towards potentially treating children with FSGS kidney disease globally.

Executive Commentary on MHRA Approval

It is pleasing to see that the MHRA approved PIP aligns extremely well with the European EMA PIP and the US FDA advice. Our single Phase 3 clinical study, having successfully passed its first efficacy interim analysis is now being rapidly expanded to include new adult and paediatric sites, which will now allow recruiting children down to 12 years old as well as adults.

Summary of MHRA Approval and Outlook

Dimerix's acceptance of the Paediatric Investigation Plan (PIP) by the UK MHRA for the development of DMX-200 for FSGS treatment in children marks a significant milestone. The approval aligns with the US FDA advice and the European Medicines Agency (EMA) approved PIP, aiming to generate sufficient data in the Company's ACTION Phase 3 study to potentially allow for marketing approval for children. This development is crucial in addressing the unmet medical needs in paediatric patients with FSGS, a leading cause of kidney failure in children. Dimerix's ambition to include paediatric patients in its clinical studies demonstrates its commitment to advancing potential treatments for FSGS, with the potential to improve the lives of children suffering from this rare and serious kidney disease.