European regulator accept Dimerix’s Paediatric Investigation Plan to develop DMX-200 for kidney disorders

Biopharmaceutical company Dimerix (ASX: DXB) has won the favour of the Paediatric Committee (PDCO) of the European Medicines Agency (EMA), as the committee has formally accepted Dimerix’s Paediatric Investigation Plan for the development of DMX-200, a potential treatment for kidney disease.

The PDCO’s approval comes after a meeting on June 23, 2023, and paves the way for Dimerix to advance DMX-200’s development for paediatric patients in the European Union (EU).

A Paediatric Investigation Plan is a mandatory development blueprint designed to ensure that new medications receive the necessary data to support their registration and usage for children within the EU. In the case of DMX-200 for Focal Segmental Glomerulosclerosis (FSGS), the Plan includes the entire paediatric development program, providing a comprehensive framework for how DMX-200 will be developed, registered and then used in paediatric patients within the EU.

CEO & Managing Director of Dimerix, Dr Nina Webster, commented, “This approval from the PDCO of the EMA will allow Dimerix to develop DMX-200 for paediatric patients, including adolescents in the current ACTION3 study. DMX-200 represents a potentially safe and effective new treatment option in these patients where there is a substantial unmet clinical need.

“We look forward to including adolescent patients in our existing ACTION3 study and to working with parents and children aged 1-11 years old following a positive outcome to ACTION3.”

Focal Segmental Glomerulosclerosis is a major cause of end-stage renal disease in children, accounting for about 20% of new cases of Nephrotic Syndrome (a kidney disorder characterised by high amounts of protein in one’s urine and other symptoms) annually. A Phase 3 study is underway for FSGS patients, with two interim analyses to evaluate proteinuria and kidney function. These analyses aim to gather evidence for accelerated marketing approval.

Part 1 of the study will conclude after 35 weeks of treatment for 72 patients, followed by potential inclusion of adolescents in Part 2.

PDCO’s nod of approval ensures that the Company’s clinical studies, including its Phase 3 clinical study of DMX-200 in FSGS, will be run in accordance with regulatory expectations for future product approval in children.

Chief Medical Officer at Dimerix, Dr Ash Soman, said, “Paediatric nephrologists are desperate for new treatments for their patients, with no drugs registered for paediatric FSGS patients anywhere in the world and very new drugs under investigation for children. We are actively engaged with networks of paediatric nephrologists and patient advocacy groups to generate high-quality data to support the registration of DMX-200 in this typically underserved population.”

The successful completion of the clinical trial in paediatrics would allow Dimerix to apply for additional market authorisation (MAA) in Europe. This could potentially expand its market access in the paediatric population, where no approved therapy currently exists.