After a lupus nephritis drug he initially developed in the 1990s officially passed its final clinical trials this week, an Edmonton biotech executive and doctor expressed “vindication.”
“There are almost no words to describe how it makes me feel,” said Dr. Robert Foster. “Along the way, when you’re developing the drug from the get-go, you encounter a lot of naysayers.
“Edmonton isn’t known for making drugs… But we stuck with it and we did it.”
The drug itself, voclosporin, is a calcineurin inhibitor that essentially lowers the autoimmune attack that lupus nephritis causes. While the disease is currently treated with steroids, voclospirin would be the first drug to specifically target lupus.
Foster said he first conceptualized the drug in Edmonton over two decades ago but there were many steps in the process of getting to this point.
“Seeing it today, becoming a reality, is an amazing thing,” Foster said. “Approximately, for about every 10,000 molecules that are discovered in a laboratory setting, only one of those will actually become a drug at a patient bedside.
“The odds are insurmountable,” Foster said.
He started working on the drug in Edmonton, as the CEO of biotech company Isotechnika. That company later merged with another to become Aurinia Pharmaceuticals, based in Victoria, which is now working to launch the drug.
“When I started out on this, I had no idea what I was getting into. I had no idea it was going to take so long,
“It does take a village. It’s fine to have the original concept… one person can’t do it all,” Foster said.
“It is like a team sport and everybody had to play their role.”
Voclosporin was granted Fast Track Designation by the FDA in 2016. Aurinia will submit a New Drug Application in 2020, with hopes it will be available to patients in 2021.
Lupus nephritis causes the immune system to lose the ability to tell the difference between intruders and the body’s own tissue. The immune system then attacks healthy parts of the body.
It’s estimated lupus affects one in every 1,000 Canadians.
Foster, who is also an adjunct pharmacy professor at the University of Alberta, is now running another company, Hepion Pharmaceuticals Inc. He said he’s now working to develop a drug to treat fatty liver disease.