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Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): Here's What You Need To Know

Aurinia Pharmaceuticals Inc (NASDAQ:AUPH): Here's What You Need To Know
Written by
Chris Sandburg
Published on
October 7, 2016
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All too often in biotech, a company will put out a press release detailing some trial data, and the same press release will spread throughout the investment community influencing bias as it goes. Media outlets will throw together coverage copying and pasting paragraphs from the study data – results, endpoints, indication etc., and that's what investors use as a base of their decisions.Here at Insider Financial, we think our readers deserve to be more informed than the majority.With this in mind, here's what the latest Aurinia Pharmaceuticals Inc (NASDAQ:AUPH) data really means, and what its implications might be for the company (and its shareholders) going forward.So, the latest data actually relates to two separate studies – one open label, small scale study (10 patients) conducted in Malaysia and another, larger scale (total enrollment is targeted at 258) study conducted in patients in the US.Strangely enough, markets seem to have assigned more value to the open label, but it's the larger double blind trial that is going to drive value going forward, so we're going to focus on that one for the purposes of this discussion.Before we get to the nitty gritty, a quick overview of the drug and its target indication will help when it comes to analysis of the numbers. The drug is called Voclosporin, and it's targeting a condition called lupus nephritis (LN). Readers will likely already be familiar with lupus – it's an inflammatory disease whereby the immune system attacks its own cells. It can be incredibly severe, and anti-inflammatory drugs in combination with steroids are the SOC. They don't cure the disease, but they can help alleviate symptoms.LN is a condition that arises in lupus patients, and it's kidney inflammation that arises as a result of the overriding lupus. Around 40-50% of lupus sufferers develop LN that needs treatment.Current SOC for LN is a combination of what’s called MMF and corticosteroids, with the addition of an immunosuppression drug, generally, cyclosporine. Without cyclosporine, SOC only returns 6-month Complete Remission (CR) rates of 10-20%. Add cyclosporine, and this increases to 50-60%+. It's not that simple, however. Cyclosporine has a really nasty safety profile, and this puts many physicians off prescribing it in all but the very serious cases.There's strong evidence, however, that early treatment of LN can have a dramatic impact on down the line severity. This is where Voclosporin comes in to play. The drug is an analog of cyclosporine, designed to have a similar immunosuppressive impact but with a vastly improved tolerability profile.If Aurinia can prove that it is effective in improving CR in LN patients over steroids and MMF alone, and ideally to the degree that MMF, LN and cyclosporine is effective (the above mentioned 50-60%+ increase in 6-month CR), then not only will it swallow up the current SOC plus cyclosporine market by way of an improved safety profile, it will also have the opportunity to target the earliest LN stages, because physicians can offset down the line issues with early treatment, without having to subject patients to a nasty bout of toxicity.That's what's important here – there's a lot at stake on an efficacy readout.So looking at the trial specifically, Aurinia is trying to figure out what the best dose is to use, in an attempt to balance out safety profile and efficacy. It looked at two doses, low and high, and compared these to placebo (all in addition to MMF and corticosteroid administration).Below is the only thing you'll see us copying and pasting from any data readout:The numbers above show the two doses when compared to placebo at a 24-week readout (the first of a planned two-point readout, with the second scheduled at 48-weeks).As illustrated, control did not reach CR. Low dose reached CR faster than high dose, with a slightly better degree of stat-sig. Looking at secondaries, low dose beat out on placebo and high dose for partial remission, and time to partial remission, across the population.Basically, the data is a blockbuster hit. The company has not only established vast superiority over current SOC, but it's also established the low dose as being superior to the higher dose, which should improve the safety profile of a phase III administration.So what's next?The 48-week readout is going to be important, as we want to see some degree of continuation of the data carrying forward into the longer term. Beyond that, we are looking for a comparison between the two –sporines to consolidate the numbers; the latter of which will likely be built in to a phase III pivotal.Don't settle for second hand, tacked together information. Subscribe below and we will bring you more of this sort of analysis completely free. Disclosure: We have no position in AUPH and have not been compensated for this article.

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