DXB could expand FSGS addressable market by ~5-10%%

Yesterday our 2021 Biotech Pick of the Year, Dimerix (ASX:DXB), announced that the FDA approved paediatric patients (children aged 12-17) to be recruited into its FSGS study Phase III.

These patients will be counted in the final pool for analysis.

This decision by the FDA is important not only because it may help children suffering from FSGS (a rare kidney disease), but also because it increases the total addressable market for DXB’s drug.

There are roughly 220,000 people who suffer from FSGS around the world and we estimate that children make up ~5-10% of that number (based on our rough calculations - this calculation was done across publicly available sources, using ratios of incidence of FSGS).

This decision ensures that those patients can be treated (if DXB’s treatment secures FDA approval), which we think could meaningfully increase the value of DXB’s treatment when negotiating licensing and marketing deals with potential partners.

Also, if DXB is successful in bringing in these adolescents – there is a regulatory process in the US that means treating children could secure an additional 6 months exclusivity (in addition to the 7 years exclusivity in the US DXB would already get) where patents cannot be challenged and no generics may enter the market.

Now that the FDA has granted approval, DXB will look to secure a similar approval in Europe.

Along with today’s announcement, DXB provided a patient recruitment update which is currently sitting at 90 patients.

The company completed recruitment for its first 72 patients required for the interim analysis data in December last year.

The next patient recruitment milestone will be 144 patients recruited for the accelerated approval endpoint.

We think that 18 patients recruited in the past month shows momentum for the clinical trial, and we hope that this continues through 2023.