- Dimerix (DXB) receives the green light to include paediatric patients in its ACTION3 study of FSGS
- The company confirmed the US FDA has recommended the evaluation of DMX200 in adolescent patients aged 12 to 17 years in its phase three study of the rare kidney disease
- Teenagers will now be recruited for the study, joining the 90 adult patients who are already on board
- Meanwhile, Dimerix has also been in contact with the European Medicines Agency (EMA) regarding a plan to seek market approval in Europe, with the outcome expected later in the year
- Dimerix last traded at 15 cents on January 11
Dimerix (DXB) has received the green light to include paediatric patients in its ACTION3 study of focal segmental glomerulosclerosis (FSGS).
The company confirmed the US Food and Drug Administration (FDA) has recommended the evaluation of DMX200 in adolescent patients aged 12 to 17 years in its phase three study in FSGS, following a meeting.
In recommending children be included in the study, the FDA recognised the safety profile exhibited by Dimerix’s DMX-200 and said no change in dose or regime would be required.
“We are very pleased to be able to open the study to adolescent patients later in the year, which may provide a viable treatment option for these younger patients, if approved,” CEO and MD Dr Nina Webster said.
“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.”
Dimerix said the meeting also provided clarity on the remaining development of DMX-200 for younger patients through to market approval.
The company’s phase three clinical study is a short, randomised, double-blind, placebo-controlled trial of the safety and efficacy of DMX-200 patients with FSGS who are receiving a stable dose of an angiotensin II receptor blocker (ARB).
Once the ARB dose is considered stable, patients will be randomised to receive either DMX-200 or placebo.
90 adult patients have already been recruited for the ACTION3 phase 3 pivotal clinical trial.
Concurrently, Dimerix has also been in contact with the European Medicines Agency (EMA) regarding a paediatric investigation plan (PIP) to seek market approval in Europe. The outcome of this is expected later in the year.
Dimerix shares last traded at 15 cents on January 11.