Dimerix (ASX:DXB) has announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) has accepted its Paediatric Investigation Plan (PIP) for the development of DMX-200 for focal segmental glomerulosclerosis (FSGS) following the PDCO meeting on 23 June 2023.
A PIP is a mandatory development plan aimed at ensuring that the necessary data is obtained to support the registration and use of new medicines for children in the European Union (EU).
Dimerix said the PIP addresses the entire paediatric development program for DMX-200 in FSGS and provides a clear framework for the development and registration of DMX-200 for paediatric patients with FSGS in the EU.
The PIP covers all studies needed for the registration of DMX-200 in the paediatric population, and no safety concerns were raised.
The safety package was accepted, and no further non-clinical studies are required, said Dimerix.
Paediatric patients from 12 to 17 years of age will be included in the current ACTION3 study in patients with FSGS, in line with US FDA advice, and in silico modelling, simulation, and extrapolation of paediatric data from ACTION3 will be used to support a confirmatory small open-label study in paediatric patients from 1 to 11 years of age.
“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.” said Dr Nina Webster, CEO and managing director of Dimerix.
“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 DMX200 in this typically underserved population,” added Dr Ash Soman, the chief medical officer of Dimerix.