Move right along. There’s no acquisition here — for now.
Canadian biotech Aurinia Pharmaceuticals announced Thursday a new $25 million financing round to power its upcoming Phase 3 trial for lupus nephritis. The money was raised through an underwriting agreement with H.C. Wainwright & Co. and Cormark Securities.
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Back in October, Aurinia’s stock surged 10 percent in a matter of minutes, based on speculation that it would soon be acquired. Nothing substantial has been reported since and the company now has a clear financial path to get its lead drug through FDA approval — on its own.
“It gives us a runway out to the end of 2017,” said CEO Charles Rowland Jr., in a recent phone interview. “It allows us to out-license Europe and Japan in a very thoughtful way, and then bring in some debt so that we have a substantial amount of non-dilutive funding coming in to get us through the end of Phase 3.”
The focus of the funding drive is a drug called voclosporin, a souped-up version of the widely-used immunosuppressant cyclosporine A.
By attaching a single carbon extension to the existing drug, Aurinia believes voclosporin will prove to be more potent and have fewer off-target effects, due to a reduced metabolic load. Those side effects, such as increased lipids and insulin resistance, have made cyclosporine a last resort for patients already battling a complex illness.
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Up to 1.5 million Americans are believed to have some form of systemic lupus erythematosus, though it remains poorly understood and very difficult to treat. Lupus nephritis, a kidney complication, arises in approximately 60 percent of all patients.
Aurinia has had mixed success treating it to date. On August 15, the company released results from its Phase 2b nephritis trial. Voclosporin met its primary endpoint and demonstrated an ability to stabilize renal function in patients with the disease.
“This is the first global study and the only placebo-controlled study to ever meet its primary endpoint for the treatment of active lupus nephritis,” chief medical officer Neil Solomons told BioWorld.
Unfortunately, the study also produced a concerning number of deaths — 12 in the active arms of the trial. This caused the company’s stock to plunge a staggering 56 percent.
A post-trial analysis pointed to a number of reasonable explanations that had less to the with the drug and more to do with the study design; treating high-risk patients in third-world countries.
Rowland told MedCity News that the upcoming Phase 3 trial will focus on the U.S., and Europe as a result, avoiding sites in Bangladesh and Sri Lanka with poor healthcare infrastructure. Aurinia will also screen to prevent patients with comorbidities and infections from joining the patient cohorts.
Data readout from the trial is expected in 2019, setting the stage for possible commercial availability in 2020. There are many hurdles to overcome before then, but patients and physicians are already getting excited Rowland said.
Lupus has been left behind by medicine in recent years. It belongs to the same family of diseases as rheumatoid arthritis, a condition that now has many targeted drugs on the market. Lupus has just one, GSK’s Benlysta, which demonstrates marginal efficacy.
While the primary endpoint for Aurinia’s study has been focused on renal function, Rowland said the company has also been tracking patients’ overall wellbeing. It’s early days, but Voclosporin appears to help stabilize the underlying disease, not just the lupus nephritis.
In that light, Aurinia could be homing in on a very expansive market. Lupus represents a global unmet need and Rowland said the drug appears suitable for long term use.
It’s appealing stuff for an acquisition. So was it ever on the cards?
“We don’t comment on rumors,” Rowland said. “But we are a public company, we’re always for sale and we’re in a space with the only drug that has hit its primary and all of its secondary endpoints. So who knows? Down the road someone might find us attractive, but right now we’re working on licensing out Japan and Europe.”
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