DXB passes second safety hurdle in Phase 3 trial
Our biotech Investment Dimerix (ASX:DXB) is currently undertaking a Phase 3 clinical trial for FSGS, a rare kidney disease.
Today, the company announced that it had passed the second safety hurdle in its Phase 3 trial.
The independent Data Safety Monitoring Board (DSMB) reviews data from the trial and in this case, has recommended that DXB’s trial continue.
This adds to the already strong safety profile of DXB’s treatment.
Today’s announcement also confirmed important dates for the trial:
- Last patient data collection for Phase 3 study scheduled for 26 February 2024
- First interim data outcome expected to be reported on, or around, 15 March 2024
We see the results on or around 15 March as a major catalyst for the company.
While there are around 220,000 FSGS sufferers across 7 major markets - we’ve seen in the past how orphan drug pricing can lead to major re-rates for certain biotech stocks.
🎓Learn more: Orphan Drugs Explained
A few months back, we attended an investor briefing where both Neuren Pharmaceuticals and DXB presented.
Neuren is a major ASX biotech success story and is currently capped at ~$1.5BN on the back of clinical success and commercialisation of its product with orphan drug pricing.
We’re hoping DXB can follow a similar trajectory, and are looking for DXB to secure major licensing partnership deals in the lead up to or after that interim data point on or around 15 March.