Skip to main content

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.

Story continues below advertisement

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.

Related topics

Report an error Editorial code of conduct
Tickers mentioned in this story
Unchecking box will stop auto data updates
Due to technical reasons, we have temporarily removed commenting from our articles. We hope to have this fixed soon. Thank you for your patience. If you are looking to give feedback on our new site, please send it along to feedback@globeandmail.com. If you want to write a letter to the editor, please forward to letters@globeandmail.com.

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff. Non-subscribers can read and sort comments but will not be able to engage with them in any way. Click here to subscribe.

If you would like to write a letter to the editor, please forward it to letters@globeandmail.com. Readers can also interact with The Globe on Facebook and Twitter .

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff. Non-subscribers can read and sort comments but will not be able to engage with them in any way. Click here to subscribe.

If you would like to write a letter to the editor, please forward it to letters@globeandmail.com. Readers can also interact with The Globe on Facebook and Twitter .

Welcome to The Globe and Mail’s comment community. This is a space where subscribers can engage with each other and Globe staff.

We aim to create a safe and valuable space for discussion and debate. That means:

  • Treat others as you wish to be treated
  • Criticize ideas, not people
  • Stay on topic
  • Avoid the use of toxic and offensive language
  • Flag bad behaviour

Comments that violate our community guidelines will be removed.

Read our community guidelines here

Discussion loading ...

Cannabis pro newsletter
To view this site properly, enable cookies in your browser. Read our privacy policy to learn more.
How to enable cookies