AUPH reported encouraging phase 3 results in December (12/4/19) in lupus nephritis, an inflammation of the kidney caused by SLE. Its calcineurin inhibitor drug candidate voclosporin met its primary endpoint of renal response rates at 52 weeks, with 40.8% for voclosporin vs. 22.5% for the placebo control (OR 2.65; p < 0.001). Both arms had a background therapy of MMF and initial treatment with IV methylprednisolone, followed by a reducing course of oral corticosteroids. Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin over placebo in the study (see Table below). It was nice to see that there was no death inbalance, since there was an apparent false alarm in the prior trial from some third-world sites. The stock gained more than 100% on the latest positive Ph3 news.
It will be interesting to see longer term data since at least one prior trial with a calcineurin inhibitor showed early benefit, but then the control caught up by 12 months (http://bit.ly/2NTghFV).
Do you think the market reacted appropriately to the data report? Do we need longer-term data? Do you think that AUPH will face stiff competition from other calcineurin inhibitors even during its patented life, if it is eventually approved? Do we need to see more repeat biopsy data to be convinced that voclosporin is providing better outcomes for patients in the long-term? Please comment below.
See press release (including table below) here: http://bit.ly/2QC4oFF
See clinical trial entry: http://bit.ly/2QCqQP5