Calliditas sets the bar for its kidney disease rivals

Calliditas’s Tarpeyo was the first treatment to gain accelerated approval for the rare kidney disease IgA nephropathy, based on reductions in the biomarker proteinuria. Now the drug has become the first to show a benefit on the hard outcome of estimated glomerular filtration rate (eGFR), a vital step towards full approval. Calliditas’s stock shot up 37% today, but given the solidifying link between proteinuria and eGFR the group might not be able to claim its unique status for much longer. Travere is expecting eGFR data this year on Filspari, which gained accelerated approval last month. That product, and others, have shown stronger proteinuria reductions than Tarpeyo, the table below shows – although some players, like Novartis, have pressed on with less impressive data. For now, though, Calliditas will be celebrating its head start. The topline results come from part B of the Nefigard study, which measured eGFR at two years, after nine months of Tarpeyo therapy and 15 months' follow-up. It found a mean reduction in eGFR of 2.47ml/min/1.73m2 with Tarpeyo versus 7.52ml/min/1.73m2 with placebo. Now it is over to the group’s many IgAN rivals to see whether they can clear the bar Calliditas has set.

Setting the bar for the late-stage IgAN pipeline
Drug Company Description Status Reduction in proteinuria
Tarpeyo Calliditas Oral formulation of budesonide Approved (accelerated); eGFR data reported Mar 2023 34% (31% pbo-adjusted) in ph3 Nefigard
Filspari (sparsentan) Travere  Oral endothelin type A & angiotensin II type 1 inhibitor Approved (accelerated); eGFR data due Q4 2023 50% (35 points adjusted for irbesartan control) in ph3 Protect
Narsoplimab (OMS721) Omeros Anti-MASP2 antibody Ph3 Artemis-IgAN; proteinuria data due mid-2023 64% (no control arm) in ph2
Atrasentan Chinook Oral endothelin A receptor inhibitor Ph3 Align; proteinuria data due H2 2023 55% (no control arm) in ph2 Affinity
Iptacopan (LNP023) Novartis Oral complement factor B inhibitor Ph3 Applause-IgAN; proteinuria data due H2 2023  23% pbo-adjusted in ph2*
Sibeprenlimab (VIS649) Otsuka  Anti-April antibody Ph3 Visionary ends Dec 2026 43% pbo-adjusted in ph2**
*At highest dose (200mg BID); **pooled data with IV doses 2mg, 4mg & 8mg monthly. Source: Evaluate Pharma &

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