Hi II,
It’s an agreed surrogate endpoint with the FDA, Proteinuria reduction for Interim One. They will also be looking at eGFR, but Proteinuria (24 hour collection) is that endpoint as far as I understand. It takes longer to look at the eGFR slope & that is what the FDA is interested in as well for a surrogate longer term endpoint.
So those biomarkers are what the FDA will be looking at on Interim 2 results for Accelerated Approval for surrogate endpoints in a Rare Disease with FDA Orphan status, which DXB also have in EU & a clinically unmet need.
Recently I posted a video discussing CKD clinical trials & surrogate endpoints, a discussion point from ASN Kidney Week Nov 2023. This is from a Nephrologist’s perspective & discussing some CKD trials. Scroll back a bit & you will find it.
There was also a large meta-analysis of CKD trials as they want clinically meaningful surrogate endpoints. This research is ongoing through NephCure & the Parasol study, which Dimerix will be engaging with when their trial data is able to be released. This has been posted recently also (scroll back).
If the DSMB recommends the trial to continue unchanged, those endpoints including safety have been met. We have already have had 2 DSMB reviews the last being in August last year, and that is encouraging. The recommendation on both was to continue the trial unchanged.
Every one of us here has to make their own investment decisions, the risk vs reward benefit they want to take & responsible for their own DD & understanding. Noone can tell you, “sure this trial will be 100% successful” or it wouldn’t need to be done, but getting into a single Ph3 there is more of a chance of this. DXB have conducted multiple trials in CKD, not just FSGS.
When doing DD it’s good to ‘nitpick’ & satisfy yourself of any concerns you may have or things that may change over time, especially in the Regulatory Dept. What is not good is posters (including ones who have clearly just made a new HC ID) who cherry pick anything possible to try & discredit or put fear into investors minds, & that is when you need to take a look yourself & make those decisions. The important thing to remember is this trial is double blinded with quadruple masking. If you are still confused, email the company. You won’t get any PS response & you may find you get a generic response if the volume is large & it’s a common question, but what else would you expect?
The time for results is getting closer now.
Had a bit of a giggle at
@vintage post yesterday. There are alarms for bedwetting available now…I’m sure you can clip them on your undies 24/7 if needed & see when you wet your pants over an ANN via an APP.
(20min delay)