Hi MongooseMan,
Appreciate your posts and queries.
Regarding recruitment, I think you will find that our study design is not necessarily comparable to Travere. Whilst it may seem slower for DXB, this is not at all due to our inability to attract patients, but due to study design. If you consider carefully the study design, and previous company announcements, you would have known that we had completed a part 1 study in order to confirm that what was found in part 1 was consistent with what was found in our Phase 2 trial. Having passed this stage, the company has opened more sites for recruitment and should see recruitment rate pick up.
As for whether 144 will be enough or not, we shall see but the company has often cited differences in study design and MoA that bodes well for DXB. If you spend some time reading the forum, there has been plenty of fair discussions on the topic.
The relationship between proteinuria and the eGFR slope has been discussed before too though I don't think the research have shown a simple correlativity. What is compelling however, is the fact that we are not comparing one ARB to another as was the case in Travere's Duplex. We are adding a drug that is in addition to the ARB. By MoA, we are not replacing/comparing ARB but adding a CCR2 blocker. Nina has explained, many times, that conceptually this should work in tandem with the ARB to reduce inflammation. Hence, the case for DXB is certainly still one with risk but one that is to some extent "de-risked" and different from DUPLEX in that we have:
- a different study design,
- a different MoA,
- Gone through Part 1 of the interim analysis, as well as
- 2 partnerships in the bag.
Anyhow, you raise some good questions. I'm sure if you try and couple your questions with some research prior, many here would be more welcoming to your queries .
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