Bluestar is once again heading to ASN Kidney Week, this time in Houston, TX. Since our last episode, Otsuka, the manufacturer of sibeprenlimab, announced that the FDA has granted Priority Review of their BLA application; its PDUFA date is November 28th of this year. Additionally, Vera Therapeutics, the manufacturer of atacicept put out a press release this past summer that the ORIGIN Phase 3 trial met its primary endpoint of reduction in proteinuria (UPCR); participants receiving atacicept achieved a 46% reduction from baseline, and 42% reduction compared to placebo at week 36 (p<0.0001). Vera plans to submit the BLA for atacicept in 2025, which may allow for a commercial launch in 2026. And these are just the recent developments in IgAN. Travere Therapeutics, manufacturer of FILSPARI (sparsentan) presented data from their FSGS trial – DUPLEX – at Kidney Week 2023 in Philadelphia. In contrast to the contemporaneous PROTECT study in IgAN, DUPLEX did not meet the primary endpoint. Subsequently, Travere has worked with an FDA advisory committee, reanalyzed the trial data, and announced last month that it has filed a sNDA for approval in FSGS; the PDUFA date is January 13th, 2026.
After the 2023 conference, Dr. Pietro Canetta joined Bluestar Principal Jeff Fineberg on the Biotech Matters podcast to talk about all things IgAN, as well as the two FILSPARI trials and the data presented at the conference. So, it's only fitting that Dr. Canetta is back on the podcast to revisit that conversation, discuss what has happened in the two years since, and tell us what he's most looking forward to at this year's conference.
Where to find Dr. Canetta:
Columbia University Glomerular Center
Where to learn more:
Glomerular Disease-Focused CME Course
Topics and Timestamps
- 00:00 - Intro + recap
- 04:00 - Reflection on Filspari in FSGS; implications for UPCR in FSGS and other diseases going forward
- 12:40 - DKD: better/newer surrogate endpoints; matching patients to the right Tx
- 19:30 - IgAN: the 4-hit model of disease and the role of B cells
- 22:45 - Where do B cell-targeting therapies fit in the evolving IgAN Tx Paradigm?
- 26:45 - The counter argument to using Bcells early in IgAN treatment
- 30:10 - Bcells beyond IgAN: Lupus Nephritis and other glomerular diseases
- 33:00 - Different B cell-targeting mechanisms for different glomerular diseases and/or heterogeneous patient populations
- 36:45 - A homecoming for complement inhibitor therapies
- 42:00 - Other recommended sessions at Kidney Week 2025
- 45:00 - Where to learn more from Dr. Canetta
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