A breakthrough drug to treat lupus nephritis that was initially developed by an Edmonton biotech doctor in the 90s has now been approved for use by the FDA.
Dr. Robert Foster said he thought up the initial idea for the drug Lupkynis (voclosporin), a calcineurin inhibitor that essentially lowers the autoimmune attack that lupus nephritis causes, in Edmonton in 1993.
“In the beginning, I started the company in my basement,” Foster said. “For the first couple years… it was just myself, sitting at a desk.”
Lupus nephritis is an inflammation of the kidneys caused by systemic lupus erythematous. The immune system loses the ability to tell the difference between intruders and the body’s own tissue and attacks the patient’s kidneys.
Foster said he based the initial concept for the drug on the molecule cyclosporine, which was launched in the 80s and used initially to prevent organ transplant rejection.
“Because (cyclosporine) downregulated the immune system… it could also be used for treatment of things that we call autoimmune diseases,” he said. “At that point I had to find help. I needed a chemist to synthesis it.”
Foster brought in more scientists to help him at his Edmonton-based biotech company Isotechnika. Initially, testing of voclosporin was done at the University of Alberta.
That company later merged with another to become Aurinia Pharmaceuticals, based in Victoria, which did the final leg work to launch the drug.
“I’m immensely thankful to the Aurinia people,” Foster said. “Without them, this drug would have never seen the light of day.
“It really does take a team to really get a molecule all the way from the beginning to the FDA approval.
“It was really home grown. The dream was (in Edmonton). It was initiated here,” Foster said. “The chemistry started here, the testing started here. Ultimately it probably included, I would say 150 people or so that were involved in the whole process here all the way from cradle to the patient bedside.”
The FDA approved voclosporin — which will be sold under the name Lupkynis — on Jan. 22.
“I was jumping, jumping for joy,” Foster said. “It was amazing. I don’t know if I’m ever going to have that feeling again.
“I’ve got four kids, (I’m) happily married. There (had) been five big events in my life up until the FDA approval — I’d call that the sixth one.”
Foster said having the FDA approval will make it easier to get the drug available worldwide, but he doesn’t yet know when it will be available in Canada.
“By having the FDA approval, other territories or countries will look at that, and they’ll really look at it seriously,” he said. “The drug has been shown to be safe, well-tolerated, efficacious — in other words, it works.”
It’s estimated lupus affects one in every 1,000 Canadians.
“(Lupkynis) puts people in remission,” Foster said. “And it does it quickly. So that’s really huge.”
Foster, who is also an adjunct pharmacy professor at the University of Alberta, is now running another company, Hepion Pharmaceuticals Inc. He is currently working to develop a drug to treat fatty liver disease.