‘Fantastic’ results from lupus-drug trials add nearly $1 billion in day to Vancouver Island firm
Credit to Author: Ken Bradshaw| Date: Fri, 06 Dec 2019 14:35:16 +0000
The value of shares in a Saanich-based pharmaceutical company soared Thursday after the firm announced what it called “fantastic” results from the third phase of clinical trials for a drug used to treat a kidney inflammation caused by the autoimmune disease lupus.
Lupus nephritis, which affects about three million people worldwide, can lead to kidney damage, kidney failure and death.
With more than 41 million shares changing hands, Aurinia Pharmaceuticals closed up 78.8 per cent at $15 US a share on the NASDAQ composite stock exchange. It was up 77.5 per cent at $19.75 Cdn on the TSX, with 1.45 million shares in play.
“It’s an exciting time for the company,” said chief executive Peter Greenleaf, noting his team of 50 has been working toward this point for a number of years.
“It is a great day for patients suffering from lupus nephritis.”
He said the company looks forward to putting the drug, voclosporin, through the U.S. Food and Drug Administration process and other global markets, so it gets to patients as quickly as possible.
That could be as soon as early 2021, he said.
“It will be different from market to market, but in the U.S., we estimate we will file for new drug approval in the first half of next year and hope for approval in early 2021,” said Greenleaf.
Thursday’s trading frenzy came after news that the company’s third-phase clinical trials of 357 patients around the world showed those being treated with voclosporin had a “renal response” rate of 40.8 per cent, compared with the control group, which saw improvement in 22.5 per cent of the cases.
In a statement, Brad Rovin, chief of the nephrology — or kidney — division at Ohio State’s Wexner Medical Center, called the results a potential game-changer.
The Phase 3 results represent a “clinically meaningful leap forward” in the treatment of lupus nephritis, he said.
“Importantly, the data indicate no excess of adverse events in the voclosporin group compared to patients managed with standard of care alone.”
Chief medical officer Neil Solomons, a Victoria resident who founded Aurinia with Mike Martin and Richard Glickman, said when he took the Aurinia team through the trial results after markets closed on Wednesday afternoon, there was palpable excitement from everyone in the room and on a conference call.
“As I took them through the data, there was a loud cheer,” he said. “We are a tiny company of 50 people. It was quite a remarkable moment.”
He said being small can be an asset, as small groups of dedicated people can sometimes get a job done more effectively. “Everyone feels ownership of this,” he said.
Co-founder Martin, another Victoria resident, said he had been on pins and needles in the past few weeks, but the past 24 hours have been fantastic.
“And so meaningful for patients,” he said. “We have something that is going to make a difference in a lot of patients’ lives.”
He noted that the bio-tech firm, located at the Vancouver Island Technology Park, is now a $1.86-billion Cdn company in terms of market capitalization — the total value of a company’s shares, and is now the most valuable bio-tech firm in Canada.
“That’s pretty exciting and kind of makes your toes curl,” he said.
Greenleaf said the team will enjoy the moment, but expects to go right back to work, filing with the U.S. Food and Drug Administration and looking at the regulatory work to get approvals in other countries, including Canada.
“Excitement for people is palpable because they now see a future,” he said, noting they have been working in a risky world where a failure at trial can kill a drug. “When you have the win, you have some stability to build and grow into the future.”
aduffy@timescolonist.com