FDA IND Approval for Phase 3 Study of DMX-200 in FSGS

Our Phase III biotech Investment, Dimerix (ASX:DXB) secured approvals in another important jurisdiction for its clinical trial.

The company got FDA approval to conduct its ACTION3 study under the Investigational New Drug (IND) regime in the US.

This directly advances Key Objective #1 in our DXB investment:

The significance for us as investors is that DXB now has a clear run at proving its treatment for a nasty kidney disease (FSGS) is both effective and safe.

This was the last jurisdiction we were waiting for, and DXB now has approval in 12 countries and has 19 of 75 sites located in the US - a key market for DXB.

There are roughly ~80,500 FSGS patients in the US currently, and the addressable market globally comes to around $1B.

DXB remains well funded with ~$16.8 as at 30 March 2022.

We anticipate the first patient to be dosed soon, the next milestone on the way towards interim results analysis slated for H1 2023.

FSGS remains our “Main Bet” for DXB and we’re looking forward to that interim analysis, which we think may be an opportunity for a major share price re-rate.

What’s next for DXB? We’re looking for the first patient to be dosed and full recruitment for the FSGS trial.

Here is why we invested in DXB (our Biotech Pick of the year for 2021) and what we expect them to achieve in 2022 - DXB Investment Memo.