DXB to expand patient base in Europe?

Published 06-JUL-2023 10:00 A.M.

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Today, our Phase 3 biotech Investment, Dimerix (ASX: DXB) announced that the European Medicines Agency had accepted DXB’s Paediatric Investigation Plan (PIP).

This will allow Dimerix to develop DMX-200 (DXB’s FSGS treatment) for paediatric patients, including adolescents in the current ACTION3 study.

We previously said in our last DXB note that there is significant deal activity in the kidney space, particularly for rare diseases like FSGS - DXB’s primary focus.

Focal Segmental Glomerulosclerosis 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.

This means that today’s development could materially increase the total potential patient base for DXB in Europe.

Bottom line: this news could increase the appeal of DXB’s FSGS treatments to potential acquirers/licensees. We think a larger potential patient base increases the total $ value of any deal that DXB might enter into.

And in March this year, DXB said it was in “advanced partnering negotiations with material offers received from multiple parties for various territories”.

We hope DXB can achieve a positive outcome from those negotiations and complete its Phase 3 study, meeting primary endpoints.

What’s next for DXB?

🔄 Completion of recruitment (144 patients)

We’re looking for additional patient recruitment updates on the 144 patients DXB needs to complete Part 2 of the trial which could unlock accelerated marketing approval. The latest update has placed the number at 116 enrolled patients as of 28 April 2023.

🔄 The big catalyst: interim analysis results (Part 1 data outcome)

Based on what we know about the timeline and structure of DXB’s Phase 3 trial, we anticipate the interim analysis results in Q1 2024.

The results in the interim analysis will come via the independent Data Safety Monitoring Board (DSMB) which will essentially determine if the trial should continue through to the final endpoint, as it has access to unblinded data from the trial.

The DSMB decision will be binary and a positive result we think would be a proxy for determining the efficacy of DXB's treatment - i.e. if it's getting results along a key metric for kidney function improvement then the DSMB will recommend the trial continue.

This is a binary result for DXB and as such we only have a bull and a bear case: