RETA: PGS, are you still following this? I note that the P2 portion of the CARDINAL study easily achieved efficacy goal, and safety at 12 weeks was apparently fine. But the P3 portion goes for much longer. Readout in three years, treatment of about two years; this will certainly produce a safety signal. The CATALYST trial in PH will readout in one year, but treatment period is only 24 weeks, so we may not get much of a read on long term safety from that. Do you know if the company has any interim looks at the CARDINAL data scheduled? Obviously, if signals start to show up, what we'd likely see is a stoppage by the DSMC.
As you've said, they are trying to titrate here to get through the therapeutic window, with doses potentially up to 50% higher than in the failed diabetes trial, based on initial ACR.
I note that in the terminated P3 diabetes trial, average drug exposure was was about 29 weeks, but the Kaplan-Meier plots show a pretty early separation - at four weeks there already seemed to be a signal.
Given this, ceteris paribus, I would guess the CATALYST trial might get stopped for safety first, some time in the second half of this year. BUT, the dosage is at most half what was used in the diabetes trial. So maybe the trial is completed, but fails on efficacy.
My thinking is that RETA is potentially a short candidate early this summer.
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