May. 20 at 10:07 AM
$AUPH Of note, they used the max. allowed 21 days to register this P2 study probably when first patient rolled over from open-label P1b to blinded P2. This suggests they wanted to keep things under wraps as long as possible and I assume P1b really started Nov/Dec 2025. For comparison with Alpine's IgAN study they presented initial efficacy data 3 months after P2 initiation, however, their trial was open-label whereas this one will be blinded which is better but it's an open question if they have incorporated interim readouts into the design. One or two indications may soon follow suit of gMG, which is a
$2B+ market in the US, looks relativelly crowded but probably not in B-cell therapies (more like Complement inhibitors and FcRn antagonists). Anyway, finally they've got their pipeline going!
Study Start (Actual): 2026-04-22
First Submitted: 2026-05-13
Also of note, Vertex runs a similar smaller study in parallel for povetacicept ETA 2029: https://clinicaltrials.gov/study/NCT07501702
