Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) is a real winner towards the end of this week, on a fresh batch of data from its lead lupus study. The data derives from a phase II study, which already read out mid last year, but this follow up was important for reasons we will touch on in a little more detail shortly. Pre market on Thursday, the company is up close to 50%, having registered gains just shy of 5% during the live session on Wednesday.
So, what’s driving the gains and what’s next?
Let’s take a look.
For those new to Aurinia, this one is a young biotech that is trying to develop a drug that tackles a condition called lupus nephritis (LN). LN is a type of secondary condition that comes about on the back of a patient suffering from a primary condition of systemic lupus erythematous (SLE), and it’s characterized by inflammation of the kidney. Specifically, when the primary SLE involves the kidneys (which it does in a large portion of cases) the patient I sat risk of LN. It’s all about inflammation. Lupus is an autoimmune disease, and as with so many of these types of diseases, it causes unwanted and excessive inflammation. This inflammation, when in the kidneys, and when it’s caused by lupus, is called LN.
So, the drug the company is testing is called Voclosporin, and it’s an immunosuppressant by MOA. The theory is that by suppressing the immune activation that is caused by the lupus condition, the inflammation will also suppress, and the nephritis will ease.
The current standard of care in the space is an extended course of steroids. This has obvious problems, including a spate of unwanted (and potentially even dangerous) side effects. Without the steroids, however, the LN will cause the kidneys to become inflamed and leak protein, causing tissue damage and – in the most severe cases – renal failure.
With Voclosporin, Aurinia is trying to bring an alternative to market that doesn’t bring with it the dangerous side effects that steroids do, but that also treats the LN. And efficacy data, to date, has been excellent. Last August, the company put out data from the study in question, detailing safety and efficacy after 24 weeks of treatment. The data pitched the drug against placebo in patients who were already on the standard-of-care therapy. The trial hit its endpoint (improvement in remission rates) but at the same time, and very much to the company’s detriment at report time, there were 13 deaths in the study. Of these 13, 12 were on the active arm of the trial. That led many to believe that the drug caused the deaths, although the company maintained that they were not drug related.
The latest data follows on from the initial report, but at week 48 post admin. The efficacy data remained excellent, and – probably more importantly in the wake of the 24-week readout – the safety data was vastly improved. Specifically, no more active arm patients died, while three patients that were being treated with placebo did.
Now, of course, no one wants trial deaths. However, in this instance, that a number of patients died in the control arm (while no extra patients died in the active arm) will contribute to the statistical insignificance of the active arm deaths at 24 weeks.
So, what’s next?
This was a phase II trial, as we’ve mentioned, and it’s now all about getting this drug through a pivotal study in an attempt to replicate the efficacy data, while not compromising the safety side of the equation. The company has already put together a phase III protocol, and has had it green-lighted by the FDA, so it’s just a case of getting this trial underway and then looking towards readout. Based on the latest communication from management, and we should see enrollment for the study kick off at some point during the second quarter.
From a market capitalization perspective, we expect this one to hold its current levels as a floor going forward, and then likely advance into the initiation of the pivotal study as speculative buy volume takes a position ahead of read out.
Bottom line, efficacy maintained, safety seems clear, issues (somewhat) resolved. Aurinia is one to watch going forward.