Replies to post #246320 on Biotech Values

[Whalatane]

rfj thanks for the comments
NVS's drug in P 2

In the Phase II study (NCT03373461), patients (n=112) with IgAN were randomized to placebo or different doses of iptacopan1. The primary endpoint was met with a statistically significant (p=0.038) dose response effect on reduction in proteinuria (as measured by 24-hour urinary protein to creatine ratio [UPCR 24h]) with iptacopan vs. placebo, at 90 days1.
At the highest dose of 200mg twice daily a 23% reduction in proteinuria was predicted, compared with placebo, at 90 days1.

P2 data from KDNY shows 48% reduction in proteinuria in 84 days AFFINITY trial
Not sure if this data is in combination with an SGLT2 inhibitor

The recently approved FILSPARI shows a similar reduction in proteinuria as KDNY's drug ...but has a boxed warning and a REMS
Also
The recently approved TARPEYO ( accelerated approval ) had a 27% drop in UPCR and is expected to be priced somewhere between $6k-$12k a month
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The above is just from quick notes
Correct if necessary .
I need to compare with OMER's IgaN data ......but if the interim analysis for KDNY's drug at 36 wks shows close to a 50% drop in UPCR , I expect them to file for accelerated approval with eGFR data to follow

NVS P3 trial ...completion early 2025
https://clinicaltrials.gov/ct2/show/NCT04578834
KDNY P 3 trial completes late 2025 but a 36 wk readout out late this year I believe
https://clinicaltrials.gov/ct2/show/NCT04573478
Kiwi