Aurinia basks in the light of Aurora
Following its voclosporin's phase III lupus hit Aurinia intends to launch in the US on its own, but seeks partners for other areas.
The results of the pivotal Aurora trial of Aurinia Pharmaceuticals’ voclosporin in lupus nephritis did not quite hit the slam-dunk response level some had been hoping for, but the benefit it did show was good enough to send shares up 88% in early trade.
This leap is as much about safety as efficacy. The side-effect profile looks good, a relief after the imbalance of deaths seen in phase II. Aurinia is to file the calcineurin inhibitor in the US in the first six months of 2020 with launch, which the group will conduct alone, pencilled in for 2021.
The Aurora trial tested voclosporin versus placebo on top of the standard of care in lupus nephritis: mycophenolate and initial treatment with IV methylprednisolone followed by oral steroids. 357 patients with the disease, in which systemic lupus causes kidney inflammation, were enrolled.
Some analysts had suggested that the best-case scenario was a 20% benefit over the control arm on the primary endpoint of renal response, defined using a combination of urinary protein-to-creatinine ratio and estimated glomerular filtration rate, at one year. The magnitude of the benefit was in fact 18.3%, a comfortable and statistically significant hit on the endpoint.
Site specific
Aurinia can also claim a clean sweep on the trial’s pre-specified hierarchical secondary endpoints, and safety much improved from the phase II Aura-LV trial. In that study more patients in the treatment arm than in the control arm died – the deaths were determined not to be drug-related, but they hardly inspired confidence.
| Aurora results | ||||
|---|---|---|---|---|
| Measure | Voclosporin | Control | Adjusted benefit | P value |
| Renal response at 52 weeks* | 40.8% | 22.5% | 18.3% | < 0.001 |
| Renal response at 24 weeks | 32.4% | 19.7% | 12.7% | 0.002 |
| Partial renal response at 24 weeks | 70.4% | 50.0% | 20.4% | < 0.001 |
| Partial renal response at 52 weeks | 69.8% | 51.7% | 18.1% | < 0.001 |
| Time to UPCR ≤0.5 | Voclosporin faster than control | - | < 0.001 | |
| Time to 50% reduction in UPCR | Voclosporin faster than control | - | < 0.001 | |
| *Primary endpoint. **Hazard ratio rather than odds ratio. UPCR=urinary protein-to-creatinine ratio. Source: Aurinia press release. | ||||
The Aurora data have put any lingering safety fears to bed. Serious adverse events were seen in 20.8% of voclosporin patients, but was numerically lower than the 21.3% rate in the control arm.
The mortality rate favoured the drug, with one death in the voclosporin arm and five in the control group. This is a reward Aurinia has reaped for excluding certain sites from Aurora. The worst mortality in the voclosporin group in Aura-LV was due to “poor access to healthcare in a subset of trial sites (ie southeast Asia),” according to Leerink analysts.
Full data are to be released at a conference, with the European Lupus Meeting in March or Eular in June possible venues.
Partners wanted
Assuming the data are good enough for approval, which is not too great a leap, Aurinia intends to market the drug in the US on its own. Speaking on a conference call today chief executive Peter Greenleaf said that it was too early to discuss pricing, though he added that lack of innovation in lupus nephritis should give Aurinia a fair amount of negotiating leeway with payers.
As for other countries, Mr Greenleaf reiterated the company’s previous statements that overtures from potential partners interested in the rights in Europe, Asia and Latin America were welcome.
“It’s pretty rare that you end up with a phase III result like we have with an asset that you’ve not already sold into other geographies to help capitalise the company,” he said. “Today as we sit, this drug is unencumbered in most of the major regions, if not all.”
Aurinia, which now boasts a $1.6bn market cap, is in a much better negotiating position.
