Biotech Values

[iwfal]

RTRX -

This is the same concern I had with RTRX and sparsentan in FGGS. The story from RTRX sounds great, but I have a kidney doc friend who warned me on this. I actually asked via IR whether in the Ph2 trial with sparsentan was there an effect on eGFR.

They presented eGFR data, and as had I predicted (see https://investorshub.advfn.com/boards/read_msg.aspx?message_id=126681367), it negatively impacted eGFR. In a longer trial the eGFR might recover, but clearly FSGS is not somehow different just because it is a more proteinuric disease.

This criticism of kidney studies with so-called wannabe DMARDs in clinical trials is crucial

As I tweeted recently, I think DMARD is only likely to be true if the slope of eGFR (vs placebo) is modified (as measured from, say, 6 months after start of treatment - because many of these drugs have transient GFR impacts). This means, for instance, that even if RETA can avoid the oedema toxicity patients, it isn't really a DMARD. Just a stop gap since it doesn't modify the slope. (Note that ACEs and ARBs do modify the eGFR and thus, IMO, can be considered DMARDs in CKD.)