Clinical-stage biopharmaceutical company Dimerix (ASX:DXB) has been given the greenlight from the US Food and Drug Administration (FDA) to include adolescent children (12-17 years old) in its ACTION3 global phase three Focal Segmental Glomerulosclerosis (FSGS) study.
The decision by the FDA comes following a meeting between the company and the FDA, in which both parties discussed the paediatric plan for Dimerix’s DMX-200 product.
The company says the decision, if approved, has the potential to increase the total addressable market for DMX-200 and displays the appropriate safety profile exhibited by DMX-200.
Adding on, Dimerix states no change in dose or regime will be required for this newly included population and that the meeting also provided clarity on the remaining development of DMX-200 required for paediatric patients younger than 12 years old with FSGS through to market approval.
“This formal meeting with the FDA gave us a valuable opportunity to discuss our paediatric plans for DMX-200 in the US”
Commenting on the ACTION3 study, Dimerix Chief Executive Officer (CEO) and Managing Director Dr. Nina Webster said: “The FDA have consistently encouraged Dimerix to develop DMX-200 for children given the very poor prognosis in this disease and lack of targeted therapies. This formal meeting with the FDA gave us a valuable opportunity to discuss our paediatric plans for DMX-200 in the US.
We are very pleased to be able to open the study to adolescent patients, if approved. The inclusion of patients aged 12 and above will also increase the total pool of patients that could be recruited into part 2 of the ACTION 3 study – potentially accelerating the rate of recruitment for the study.
This initial discussion regarding adolescent enrolment in the ACTION3 study builds on the numerous constructive discussions we have had with key regulatory agencies worldwide. Following this meeting, we will continue discussions with the FDA to support development of new therapies in this population of adolescent patients who have very few therapeutic options currently available or in development.”
The company also notes it is also in discussions with the European Medicines Agency (EMA) regarding a Paediatric Investigation Plan (PIP), which is a regulatory requirement prior to seeking market approval in Europe. An outcome to this investigation is expected to be delivered this year.
In addition, Dimerix reports 90 adult patients are currently recruited in ACTION 3 phase 3 pivotal clinical trial of DMX-200, and that part 1 interim analysis, which will assess proteinuria reduction of the first 72 patients on the product versus placebo at week 35, is anticipated in the latter half of 2023.
Meanwhile, all activated sites will continue to recruit suitable patients for part two of the ACTION3 trial.
Dimerix is an ASX-listed biopharmaceutical company actively working to develop innovative new therapies in areas with unmet medical needs for global markets. The company is currently developing its proprietary product DMX-200 to fight FSGS, a rare disease that attacks the kidney’s filtering units causing irreversible scarring, permanent kidney damage and eventual end-stage kidney failure.