Aurinia Pharmaceuticals Inc (AUPH)

[CoolG73]

Here is the details of the Roche study

https://www.roche.com/dam/jcr:656bf1a5-768c-4d91-a3db-b7440c3d6e7a/en/irp20191112.pdf

now this is how it compares to VCS (on the Placebo side):
1) Steroid use : median Roche is 11 mg/ day vs VCS: 5.4 mg /day
2) UPCR : mean Roche : 2.9 vs VCS : 4.4
3) MMF use same amount for both studies 2 mg/day
4) Alternative CR at 52 weeks without the sediment criteria Roche: 28% (Placebo)
5) Most patients in Roche are Hispanic which is aligned with VCS AURORA trial

Discussion:

SO basically if we use the same CR criteria of Roche, our CR for the placebo should be around 28%. but VCS has some requirements that Roche DO NOT have:

1) No Rescue therapy allowed. this shed 9% automatically from Roche CR since they had 19% that required Rescue therapy (10% of them discontinued)

2) No high dose Prednisone allowed in the last9 weeks of the study (week 44 thru 52) AND our steroid taper is more aggressive (our median was 5.4 mg/day vs 11 for Roche . so this criteria should reduce the CR % further

Conclusion:

1)The Roche study Placebo CR should read MAXIMUM 19% if they apply the VCS CR requirements

2) the Death was 7% in the Roche study Placebo study, where patients were mostly taken from Latin America and the States. I know this doesn't imply we will have the same % in AURORA but it is something possible , and if we have the same rate it will help with the safety issue we had in AURA.

This gives me more confidence that we will achieve the Primary endpoint in AURORA .