Shares of Victoria-based drug developer Aurinia Pharmaceuticals Inc. soared in after-hours trading Wednesday after it reported positive late-stage results for a drug that prevents kidney failure in lupus patients.
The stock of Nasdaq-listed Aurinia was up by more than 100 per cent – topping US$17 a share after closing the day at US$8.39 – following the release of results from its latest human trials of voclosporin, its treatment for lupus nephritis. The condition, which affects about one million people, or 50 per cent of lupus-inflicted patients worldwide, results in their immune systems attacking the kidneys, often resulting in organ failure or disease.
Aurinia said its drug proved to be both safe and effective in a global study of 357 patients, improving kidney health of 40.8 per cent of patients tested with the drug compared with 22.5 per cent with a placebo.
It was “well tolerated with no unexpected safety signals," it said, with one patient using the drug dying during the trial, compared with five on the placebo. That was in contrast to an earlier-stage human trial, in which more patients died taking the drug than the placebo. The company later addressed concerns by explaining the deaths happened in developing countries with poorer standards of care, as far fewer patients died on a lower dose than those on a higher dose.
“This extraordinary pivotal data confirms voclosporin’s ability to achieve statistically significant improvements in clinically meaningful endpoints for this complex disease, with a comparable safety profile to the current standard of care,” Aurinia chief medical officer Neil Solomons said in a release.
“These data represent a potential game-changer for patients suffering from this debilitating disease [and] represents a clinically meaningful leap forward” in its treatment, Brad Rovin, chief of the division of nephrology and medical director of the Clinical Trials Management Organization at the Ohio State University Wexner Medical Center, said in a release.
Mackie Research Capital analyst André Uddin said in a report last month that positive results in the trial “should quickly turn [Aurinia] into a commercial-stage company,” as there is no drug for the condition approved by U.S. or European regulators. Peak sales could top US$750-million a year, he said.
Aurinia said it plans to file a new drug application with the U.S. Food and Drug Administration in the first half of 2020 and could launch the drug a year later if approved.