Hi Kdwc,
Yes your memory is OK! it happened on topline results from DKD 2b trial - there was an investor call after that & then further data analysis later on. We have discussed this prior many times (see prior posts). The trial was a crossover design, so not randomised placebo vs drug, each patient was their own control so to speak, & yes potentially legacy effect. The other factor was patients with a lower baseline albuminuria recruited onto the trial that I believe affected the topline results. I believe there is still the Webinar up if people want to listen & investigate themselves & the post hoc data analysis in ANNs. The responders were the sicker ones with higher baseline Proteinuria (as per the endpoints), but it’s still worth looking into all of that & I think that topline results were misleading due to the above.
The recommendation was for a longer placebo controlled Ph2 in DKD from memory. Its all in the ANNs guys, just takes a while to go back & DYOR.
It (the dump & crash) had nothing to do with FSGS data Ph2A.
Dimerix made it pretty clear that they would be progressing their Orphan status indication for DMX-200 & focusing on that for obvious reasons in a Ph3 (read up on Orphan status if not familiar) & now we also have been approved to have paediatrics on this trial.
COVID-19 happened, & we had 2 external International platform trials trialling DMX-200 during this time.
So DKD was put on the back burner.
We had a $20 million raise to fund Ph3 FSGS trial also. The cost of an Internationally recognised CRO to manage the trial & running currently through ~70 international sites recruiting, all the regulatory approvals in each jurisdiction - you can understand why Dimerix can’t do everything, in every indication in CKD (Chronic Kidney Disease) that DMX-200 may show efficacy in!
$20 million is peanuts for a Ph3 to get us through to Interim 1 results in a single Orphan status trial that we may receive FDA Accelerated Approval on the next interim analysis (pending results), but they’ve done it…almost, not long to wait now. First surrogate endpoint due in March 2024.
Then we received the Advanz deal with cash upfront & R&D plus Commercialisation milestones. I think March 2024 results may be a catalyst for tripping further deals, but after the surprise of the Advanz deal landing early, you just never know hey!
(20min delay)