Dimerix Receives Approval For Paediatric Investigation Plan From UK MHRA

Late-stage biotechnology company Dimerix Limited (ASX: DXB) has received approval from the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for a paediatric plan for its lead asset that could potentially treat children with focal segmental glomerulosclerosis (FSGS) kidney disease globally.

FSGS is an unmet need and one of the leading causes of kidney failure in children, with 20% of all presentations of Nephrotic Syndrome in paediatric patients caused by FSGS.

There are currently no approved treatments for FSGS, with DMX-200 being the most advanced drug in development.

DMX-200 is in a global phase 3 clinical trial for the treatment of FSGS, a rare kidney disease with granted orphan drug designation.

A successful clinical trial in paediatrics would allow Dimerix to file for an extension to any market authorisation (MAA) in UK.

This would expand market access in a paediatric population where no treatment for FSGS exists and associated healthcare costs are high.

FSGS is one of the leading causes of End Stage Renal Disease (ESRD) in children and is associated with up to 20% of all new cases of Nephrotic Syndrome in children each year.

DMX-200 Paediatric Investigation Plan

A PIP in the UK is a mandatory development plan aimed at ensuring that the necessary data are obtained to support the registration and use of new medicines for children in the UK.

The approved PIP in the UK aligns with the previously approved European EMA PIP2 and the US FDA’s advice.

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 UK.

This positive and final opinion from the MHRA ensures that the Company’s clinical studies, including its ACTION Phase 3 clinical study of DMX-200 in FSGS, will be run per the MHRA’s expectations to allow for potential future product approval in children should it be successful.

The single Phase 3 clinical study successfully passed its first efficacy interim analysis and is now being rapidly expanded to include new adult and paediatric sites.

The study will now be opened up to include children from ages 12-17 in the UK as well as adults.

Dimerix is well funded with $35.2 million of cash on 31 March 2024.

 

 

 

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