Isotechnika Pharma Inc IPHAF

biopsy proven acute rejection as stated

[labumba]

Efficacy Results

In PROMISE, the primary endpoint (biopsy proven acute rejection, BPAR) was clearly met in all three voclosporin dose groups. BPAR is a measure of acute rejection in transplant. In clinical practice, patients with more episodes of BPAR, typically 10-15% at 6 months, have worse outcomes. The results show that voclosporin is as efficacious as tacrolimus, has the dose response expected in a Phase 2 trial, and provides the rationale for dose selection for the Phase 3 clinical program.

Drug	Patients with BPAR
Low dose voclosporin	11%*
Mid dose voclosporin	9%*
High dose voclosporin	2%*
Tacrolimus	6%
*statistically non-inferior to tacrolimus -----------------------------------------------------------------------------------------------