Welcome to the Aurinia Pharmaceuticals AURORA Clinical Trials Results Conference. At this time, all participants are on listen-only mode. A question and answer session will follow the formal presentation. If you would like to ask a question, you may press star one on your telephone keypad. If anyone should require operator assistance during the conference, you may press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Glenn Glickman, Head of Investor Relations. Thank you. You may begin.
Thanks, Donna, good morning, everyone. Thanks for joining us as we take the time to review the top-line efficacy and safety results from the AURORA Phase III Clinical Trial with voclosporin. Joining me on the call this morning from the Aurinia team are Mr. Peter Greenleaf, President and CEO, and Dr. Neil Solomons, Chief Medical Officer. Last night, we issued a press release detailing the results, which are available on our website at www.auriniapharma.com, along with a 6-K that is being filed with the SEC. I'd like to remind you that today's call is also being webcast live on Aurinia's Investor Relations website, a replay will also be available following the call. The content of today's call is Aurinia's property. It cannot be reproduced or transcribed without our prior written consent. During the course of this call, we may make forward-looking statements based on our current expectations.
These forward-looking statements are subject to a number of significant risks and uncertainties, and our actual results may differ materially. For a discussion of factors that could affect our future financial results and business, please refer to the disclosure in today's press release and our most recent filings with the Canadian Securities Administrators and reports that we file on Form 6-K with the U.S. Securities and Exchange Commission. All of the statements being made during today's call are as of today, December 5th, 2019, and based upon the information currently available to us. Except as required by law, we assume no obligation to update any such statement as of this date. With all of that, let me turn the call over to our CEO, Peter Greenleaf. Peter?
Well, thanks, Glenn. Good morning, everyone. On behalf of the company, I'd like to take this opportunity to thank all of you who dialed into our call this morning. It's obviously a very exciting time for the company, and we're pleased to have you here to discuss the results of the AURORA trial on our call today. As you've seen from the press release last night, this is a monumental moment for Aurinia and, more importantly, for the patients who suffer from the impact of lupus nephritis. On behalf of the company, we'd like to thank our investigators, our team who worked tirelessly towards this outcome, our investors who believed in our mission, and most importantly, the patients and patient support groups who helped us make this trial possible.
With the results now clear, we will shift our organizational focus from clinical trial execution towards filing a new drug application with the FDA for voclosporin for the treatment of one of the most severe forms of lupus, specifically lupus nephritis. As many of you know, systemic lupus erythematosus, or SLE, is a heterogeneous autoimmune disease that can attack one or many of the body's organ systems. When the disease attacks a patient's kidneys, it is defined as lupus nephritis, and by definition, is a severe form of the disease. Patients suffering from lupus nephritis present an enormous pharmacoeconomic burden on the healthcare system, with many of these patients experiencing frequent emergency room visits, intermittent renal failure, dialysis, and ultimate require for renal transplantation.
In addition to the poor quality of life these patients suffer from, they also face a dramatically higher risk of early death compared to the general population. The bottom line is these patients can die from this disease. Currently, there are no FDA-approved treatments for lupus nephritis, so it's obvious there is a significant need for new innovation and advancements to treat this condition. We hope the encouraging data we show today provides confidence that new advancements are coming. I want to take the opportunity to relay to you that the level of confidence we have as a team and in our team here at Aurinia to execute on our next phase of execution and growth is strong. Across all functional areas, we will now pivot towards our pending pre-NDA meeting with the FDA. We expect to file an NDA in the first half of next year.
We also believe that voclosporin for the indication of lupus nephritis will be granted a priority review, which has the potential to accelerate our time to FDA approval. It is also our intent to get voclosporin to patients suffering from this debilitating disease as quickly as possible and achieve this objective globally across multiple regulatory jurisdictions. We, as a company, have been preparing for this moment for well over a year and are excited to put our plans into motion. Feel confident that whether it's a regulatory filing, continued clinical execution, or commercial execution, we are prepared for this next phase of growth. I also thought at this stage it would be important to remind everyone on the call that our clinical team is in the midst of executing on a phase II/III study of our topical formulation of voclosporin for the treatment of dry eye syndrome.
As a reminder, earlier this year, we presented the results of a phase II exploratory study comparing voclosporin ophthalmic solution, or VOS, to the current standard of care, RESTASIS. I'd encourage those on the call to look back at this data and be reminded that on secondary endpoints, VOS was statistically superior on all objective measures of efficacy in as little as two weeks. We look forward to the day when this topical formulation of VOS competes in this multibillion-dollar market as a potential best-in-class alternative. We look forward to a data readout from our phase II/III AUDREY trial in the back half of 2020. We were also engaged in an exploratory study with voclosporin for a rare kidney disorder called FSGS.
FSGS is a rare proteinuria kidney disease, and if left untreated, patients can develop end-stage renal disease, suffer transplantation, and potentially even death. Based on the mechanism of action of voclosporin, there is a strong rationale for the utilization of this drug in this indication. We look forward to reporting results of this exploratory study in the back half of 2020 as well. If it's not obvious, this is a very exciting time for our company. Without further ado, and with that quick introduction by me, I'd like to now turn the call over to Dr. Neil Solomons, one of our founders and the Chief Medical Officer of the company, to provide you with further details from the AURORA trial results. Neil?
Thanks, Peter. This slide shows you a quick reminder of the AURORA study design. 357 subjects with biopsy-proven proliferative, membranous, or mixed active lupus nephritis with a proteinuria of at least 1.5 milligrams per milligram were randomized into one of two groups. All patients received a background standard of care, including MMF and a rapid steroid taper down to a target of 2.5 milligrams of prednisone by week 16. In addition, subjects were administered either voclosporin 23.7 milligrams twice daily or placebo in a double-blind fashion. The primary endpoint was renal response at 52 weeks, defined as a urine protein creatinine ratio, or uPCR, of 0.5 milligrams per milligram or less in the presence of low steroids, stable or normal renal function, and no rescue therapy.
Secondary endpoints included renal response at 24 weeks, partial response at 24 and 52 weeks, time to uPCR of less than or equal to 0.5 milligrams per milligram, and also time to partial response. Baseline characteristics in the AURORA trial were well-balanced, with the majority of patients being females of childbearing age. The biopsy classes were also well-balanced, with 14% of subjects with pure class 5 in each arm. The mean baseline uPCR was approximately four milligrams per milligram and similar between groups. This was a global study conducted in 27 countries with approximately 30% of subjects enrolled from Asia, including Japan, 30% from Europe, and 40% from North and Latin America. Many people are interested in the racial and ethnic background of AURORA participants, especially with respect to the number of Black and Hispanic Latino patients.
You'll appreciate that race is self-reported in these studies, sometimes making it difficult to be precise. Patients self-reported as Black constituted approximately 15% of AURORA participants and 40% of U.S. subjects. Approximately one-third of AURORA subjects were Hispanic or Latino. We believe that this is representative of the U.S. population. Now we're going to go over the efficacy. The primary endpoint was met in the study with a 52-week adjudicated renal response rate of 40.8% in voclosporin-treated patients versus 22.5% in the control. That represents an odds ratio of 2.65 with a P value of less than 0.001. This significant primary endpoint, when analyzed by pre-specified subgroup analyses, which include age, sex, race, biopsy class, region, prior MMF use, including the maximum dose of MMF, was remarkably consistent, with all groups favoring voclosporin. The study was internally consistent.
With respect to the secondary endpoints, renal response was also assessed at 24 weeks, with 32.4% of voclosporin subjects versus 20% of the control arm achieving renal response at 24 weeks. This is an odds ratio of 2.23 with a P value of 0.002. More secondary endpoints, the partial response rates at 24 weeks were 70.4% in voclosporin versus 50% in the control arm. Odds ratio of 2.43 with a P value of less than 0.001. At 52 weeks, the partial remission rates were 69.8% in voclosporin versus 51.7% in the control arm, with an odds ratio of 2.26, P less than 0.001. Our assumption at this point is that between week 24 and week 52, some of the partial responders improved to a complete renal response and then were replaced by non-responders. This happened in the AURORA trial.
This slide summarizes the predefined hierarchical secondary endpoints analyzed and reviewed during this presentation. These hierarchical secondary endpoints, including renal response at 24 weeks, partial response at 24 and 52 weeks, time to uPCR of less than or equal to 0.5, and time to 50% reduction in uPCR, are very important as this analysis was agreed to by the FDA and has the potential to support labeling claims. All of these pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin. This next slide looks at the reduction in proteinuria. In addition to the hierarchical secondary endpoints, voclosporin also resulted in profound reductions in proteinuria at 52 weeks compared to baseline. An encouraging aspect of this trial was that there was no apparent safety penalty associated with the clinically significant efficacy benefit seen in multiple dimensions.
As is common in these trials, the majority of patients experienced at least one adverse event. Serious adverse events occurred in 21.3 control arm subjects, compared to 20.8% of voclosporin-treated patients. Similar rates of serious infections, treatment-related adverse events, and adverse events leading to discontinuation were seen between the groups, with five deaths occurring in the control arm compared to one in the voclosporin-treated patients. Disease-related AEs were also similar between arms. There were clinically meaningful declines from baseline in total cholesterol, LDL, and triglycerides, with greater benefit observed in the voclosporin compared to the control arm subjects. No apparent difference in glucose levels as tested by HbA1c and fasting glucose was seen between the voclosporin and control arms.
There were improvements in systolic and diastolic blood pressure seen in both groups, with no clinically meaningful differences seen between the groups and no significant difference in eGFR observed at 52 weeks. In conclusion, the strong risk-benefit observed in AURORA confirms the treatment effect seen in the AURA-LV trial when comparing voclosporin 23.7 milligrams twice daily combined with background standard of care versus standard of care alone. The odds of achieving renal response on voclosporin therapy are 2.65 times greater than on control while maintaining a favorable safety profile. The absolute risk reduction was 18.3%. Substantial efficacy benefit for voclosporin was achieved without any observed safety penalty over control.
Thanks, Neil. Before opening up to Q&A, I'd like to once again thank all the patients, clinicians, and the Aurinia team that have made this result possible. The dedication by the team focused on making a difference for people living with lupus nephritis is one of Aurinia's unique attributes. We are committed to realize the full potential of voclosporin, which could truly be a pipeline and a product. With data in hand, we look forward to submitting a robust dossier to the FDA next year to enable voclosporin to possibly be the first approved drug for lupus nephritis. With that, I'd like to turn the call back to the operator and open the line for Q&A. Operator?
Thank you. At this time, we will be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that is star one to register questions at this time. Our first question is coming from Alethia Young of Cantor Fitzgerald. Please go ahead.
Hey, guys. Thanks for taking my questions. I have a few of them, and congrats on this data. It's great. We look forward to this maybe being the first approved lupus drug. I've gotten a lot of questions overnight about your IP situation. I just wanted you to talk about that broadly, but in particular, talk about the confidence and the strength of the dosing patent and if the dosing protocol and the trial is matched to the claims of the patents, how do you think about that? My second question is just I wanted you to talk a little bit about comparing the speed of response of voclosporin and the complete response level at 24 weeks versus other CNIs as well. I have one more, but I'll let you start with those two.
All right. Well, why don't I start off with the intellectual property question, then I'll have Neil pick up the rapidity of response question. On the IP front, it's a pretty straightforward story. We have composition matter out to 2027, then in the first quarter of this year, we announced the addition of a method of use patent based upon the eGFR dosing that we used both in the phase II and the phase III trials method of use patent that was issued that takes the intellectual property portfolio all the way out to 2037. We believe very strongly in the intellectual property portfolio that we have around the drug. We'll have to see how labeling comes to light as our discussions move forward with the FDA, which we believe, if done the right way, will just continue to strengthen our method of use patent.
More to come there. Neil, do you want to talk a little bit about rapidity of response data?
Yeah. As with the AURA trial, the speed of complete remission or renal response is quicker in voclosporin-treated patients than the control arm patients. We will be presenting full Kaplan-Meier analysis at medical conferences. The other question was with respect to the comparison with other CNIs. I think we always have to be a little bit cautious about comparing across trials. To my knowledge, there's not been a global placebo-controlled study using any other CNI in combination with MMF, so I'd caution that. I would say that our results are comparable with our AURA phase II results.
Alethia.
I'm sorry, go ahead.
Before you jump onto your next question, one other thing I just did want to mention around the IP side of your question is our commercial model will help drive, we believe, quite a bit of protection around the asset as well. The level of customer intimacy we intend to put together in the U.S. market in terms of our patient care support services, et cetera, we hope will get us to a point where patients value our services commercially. Second, we really want to try to take more of an almost rare disease model towards how we commercially execute on this in the U.S., and that would include trying to lock up most of the elements of the supply chain.
This isn't an immaterial drug to manufacture, and there are only a very few manufacturers who can produce all the steps in the process. Our goal would be to find the most reputable one and continue to set up a long-term agreement that would hopefully make it difficult for others to penetrate, both on the full supply chain side and commercially. More to come as we roll out our commercial strategy. Do you have other questions?
In your conversations with docs, what's the strongest argument for voclosporin when their generic CNIs are available? My second one is just are there any reads to make the FSGS on this?
I'll start. I'm not sure I understood the last part of the question, let me start with the first part. First off, generic CNIs are not currently approved. They don't have FDA approval for use in this disease. I would say that their utilization in most markets around the world is quite limited, maybe excluding Asia, I'll ask maybe Neil to comment on that. I think it's a leap to say that this drug is comparable in any way, both at the mechanistic level, at the molecule level, and at the results level to the generic CNIs that are out there in the market space today. Our results, I think, speak for the differentiation of the molecule. The preclinical data that we put out earlier in the week, I think further shows that this is different than the two available generic CNIs today.
We'll continue to hammer that message both medically, clinically, and commercially as we drive the product into the marketplace. Do remember, this is a different drug. It's a next-gen CNI. That comes down to the molecular structure of the drug. We have preclinical data to support that differentiation, and we believe these trial results support that. Neil, would you have anything to add?
No. I think two consecutive studies showing a profound treatment effect in a placebo-controlled setting, together with the dosing that we employ and also the other metabolic benefits of voclosporin compared to other CNIs, I think tells its own story.
You had a question on FSGS.
Yeah. Just looking at, obviously, the impacts on the kidney and inflammation and proteinuria. Is there any read to make on your upcoming study in FSGS from these data? Are you more confident?
It's probably a good question for Neil, but it's my understanding that CNIs are used broadly in FSGS today. I don't know if that's universally true. They are used. Neil, you want to maybe talk a little bit about our confidence here and why?
Yeah, sure. Calcineurin inhibitors are known to be good anti-proteinuric drugs. There's a couple of reasons for that, obviously the profound immunological effect, but also the effect on the stabilization of the podocyte. We think this bodes very well for the treatment of FSGS, which is a disease characterized by podocytopathy.
Great. Thanks. Congrats again.
Thank you.
Thank you.
Thank you. Our next question is coming from Ed Arce of H.C. Wainwright. Please go ahead.
Hi, guys. Thanks for taking my questions and congrats on the positive readout. It's great to see. A couple questions here. I guess you've already spoken to the speed of effect, and your intent to give a more fulsome analysis at a future medical meeting. I guess I also wanted to ask around the ongoing extension study, and what, if anything, you've seen from extensions with AURA or the extension with this study, to the extent that you've seen any data that could support the excuse me, the thesis that even beyond 52 weeks, there is a potential here for increased response on the drugs longer term. I have a follow-up. Thanks.
Neil, you want to go?
Sure. I think the first thing to say is that the ongoing AURA extension study is blinded and is an ongoing study. We don't have any insight into that data. However, I take your point, Ed, about the improving response over time. I think that's certainly a hope that we're going to see that. The other thing that's also going to be very important in that is maintaining the long-term safety of this drug, which we've seen in other indications.
Great. Going back to the question of IP, I, too, had a couple questions about that overnight. As you know, I did some work earlier in the year around this, and we've talked about this. I guess I just wanted for all of us to remind us how this protocol came about. I understand this was really initiated at least jointly between yourselves and the agency prior to the phase II AURA, or excuse me, the AURA study, and primarily around the safety. Perhaps you could give a little background around that as well.
I think the method of use and composition of matter patents and their timing I went through earlier. Since Neil's got the history of the interactions with the agency and a deeper understanding of the dosing protocol and how it came to light here, maybe Neil, you can just talk a little bit about that.
Yeah. Thanks, Ed. It's a good question. We did quite extensive modeling before we developed the phase II protocol based on a lot of the data that we already had on voclosporin and other indications with respect to the interaction of administration of voclosporin dosing, calcineurin inhibition, and GFR changes, as well as other changes as well. That complex modeling fed into a dosing protocol, which we discussed together, obviously with the supporting data with the FDA, and that's what made it into protocol. We are really pleased to see that it actually works in both protocols. Yeah.
Great. Thanks again.
Thanks, Ed.
Thank you.
Thank you. Our next question is coming from Joseph Schwartz of Leerink Partners. Please go ahead.
Thanks very much, and congratulations as well. How are you thinking about pricing for voclosporin? Have you done pharmacoeconomic analyses to illustrate the value of being able to achieve rapid remissions, and to what extent will that guide your pricing decision versus other factors?
I think it's a good question. I think it's preliminary to really give you an answer. We just unearthed this data a day or two ago, and we're in the process of really looking at it clinically from a regulatory standpoint and ensuring that we've got everything together to get this ready for an NDA filing. I think the way the data came out, we're optimistic about both access and pricing. We've done some pre-market work. To really land on a defined price today, Joe, I would tell you, it's pretty early to try and do that. We look forward to updating you as we get a little more smart about what the data shows us.
I can tell you that today, because there hasn't been innovation in this disease, that it's not a quote unquote "really managed category by payers." That being said, we have to be responsible about how we price. We have to ensure that we work with payers to ensure access for patients, and we have to have the right support care services around and in our commercial plan to ensure that we have unrestricted access to the drug. We're pretty confident with the data that we see here that that should be a smoother path for us. We'll look forward to updating you more specifically about numbers as we get closer to understanding the data and its impact on the market.
That's helpful. Thanks. Where do you see voclosporin fitting in relative to the current standard of care? How much do you expect to be used in combination or following inadequate response to CellCept, and how much before?
We've had quite a bit of discussion about this around the table. Again, I don't want to hedge on an answer there, but we've got to go out, put this data in front of clinicians, and I'll look forward to Neil's answer if he's got a different one here. We've got to go out and talk to physicians. I guess the question that I come up with looking at this data, and not being an MD, is why wouldn't you use the drug? Why would you actually use the old standard of care with the benefit that this can add to the standard of care? I think it's a jump to say that this should be the new standard of care. I think that we've got to go out and talk to physicians and see specifically where it fits in the treatment paradigm.
In addition, there are guidelines that drive a lot of the treatment use over time. We're going to have to continue to work with the thought leaders that are out there to modify those guidelines if and when this drug is approved and get voclosporin into the mix of the guidelines. Again, the steps for us are first, we've got to get this in front of the FDA, get a robust dossier together for the NDA, and then work on labeling. From there, hopefully we get a drug approved, and then we get it into the mix of the treatment protocol for these patients. Anything you would add there, Neil?
No. What I would say is our preliminary look at the data and the fact that this drug appears to work across treatment subgroups, including those that were on MMFS screening, that were not on MMFS screening, those that have had previous prior therapies for lupus nephritis, and those that are new onset, appears to show a strong treatment benefit without safety penalty across groups. I would say that needs to be added into decision making of physicians too.
Great. That's helpful too. Thanks. Maybe one quick one. To what extent have you confirmed with the FDA that the AURORA trial can suffice as a single phase III or perhaps combined along with data that's replicated from the low dose arm of AURA as another phase III?
Yeah. I'll answer that.
Yeah, please.
At the end of phase II meeting, that was suggested by the FDA that we needed to do one confirmatory study that could support potential approval. I believe that's what we've done, that AURORA should be looked at as confirming the results of AURA. Yeah.
Excellent. Congrats again.
Thanks, Joe.
Thanks, Joe.
Thank you. Our next question is coming from David Martin of Bloom Burton. Please go ahead.
Congratulations, guys. I've got a couple of questions. The first one is the adverse events leading to death, five in the control arm, one in the voclosporin arm. What were the causes of death? Were they renal related?
Neil.
Yeah. Thanks, David. We haven't disclosed details of the cause of death yet. However, as expected in a serious renal condition such as lupus nephritis, renal events were a feature of most of the outcomes.
Okay. How about the AEs leading to discontinuation? Can you give a sense of whether they were different reasons in both arms of the trial?
There were different reasons. We haven't, again, disclosed the actual reasons for adverse events causing discontinuation from the trial, David, but we will do that at future conferences.
Okay. The last question. From the extension trial, when will we see the first data? Will you report at 12 months and then at 24, or are you going to wait for 24 months?
With respect to the extension trial, this continues as a double-blind study. The data will not be available in its totality until the end of the two years. We are providing the FDA with an interim look with respect to safety. That was a request from them in our 120-day safety follow-up.
Okay, thanks and congratulations again.
Thank you.
Thank you. Our next question is coming from Justin Kim of Oppenheimer. Please go ahead.
Good morning. Thanks for taking the questions and congratulations on the landmark results. I know it's early and the need to preserve data for future medical meetings and publications, but if I recall correctly, the types of responses observed in the second half of the year for AURA were largely patients meeting proteinuria criteria. Can you share, or do you know if a similar pattern was observed for AURORA?
Yeah, I'll answer that. The main driver of efficacy was proteinuria, indeed, in this study, similar to the AURA trial.
Okay, great. I just found the robustness of the data comment intriguing in the press release. When you mentioned pre-specified subgroup analyses on biopsy class, can you share how the biopsy class was compared or if that referred to patients of Class 5 or with Class 5 involvement?
So we-- I'm just-
Yeah, can you better help us understand the question you're asking? You're asking specifically the percentage of patients in what class?
Just that the press release had noted that the sort of efficacy results were preserved when looking at subgroup analyses, and just wondering if those subgroups with respect to class and looked at sort of Class 5 or how class was compared?
Yeah. What we did a fairly crude division of biopsy where we looked at pure Class 5 because that considers to have a slightly different histology to the others versus non-Class 5. There was efficacy benefit for voclosporin in both those groups.
Okay, great. Maybe just a final one. I know that you are working towards the regulatory filing and that it has been a rolling process. Can you maybe comment on which modules have already been completed and sort of which you expect to be the maybe gating ones in the first half of next year?
Yeah, as I've said since the day I've walked into the company, I've been very impressed by the preparedness that this very small team has had leading into this outcome. It's probably one of the most prepared approaches I've seen in my time in the industry, especially with the resources that we've had around the table. Without getting into the specifics of modules and where they're at, because we really haven't disclosed that, I can tell you that we've had a pretty plug-and-play approach. The team has been waiting to dump data into the documents for submission. We have been on target or ahead of target on submission and/or acceptance of filings across the total NDA process.
We're looking forward to a pre-NDA meeting in the first quarter of next year and a filing within the first half of next year. Everything is on target right now to do that. The team's been doing a great job, and they've been working their tails off doing it. Obviously, I've thanked them in the front end of the call, but I'll do it again. They're working tirelessly, and we're on target with where we want to be.
Okay, great. Thank you and congrats again.
Thank you.
Thank you. Our next question is coming from Douglas Miehm of RBC Capital Markets. Please go ahead.
Yeah, thanks. I just wanted to follow up on the biopsy question. It was one of the differences between the AURA trial and AURORA with respect to the timelines available for those biopsy patients. My question is, were there any differences in outcome versus those that met the AURA criteria versus the new criteria that were sort of used in the AURORA trial?
Thanks for the question. We get this one quite a bit in pre-data. The question of whether there was going to be some difference in when biopsies were taken on these patients. I'll first reinforce that the difference between the phase II and the phase III on the approach to biopsy criteria was very important as it pertains to bringing the drug to the market. There is a world, especially in the U.S. market, where payers could use that criteria as an entry criteria to getting patients on the drug. If a patient has had to have a biopsy within the last 6 months to confirm lupus nephritis, it would be a little bit more, I guess, invasive and could potentially restrict access more. To have patients have the ability to have had a biopsy-confirmed lupus nephritis within a 2-year window is much more commercially relevant.
I'll ask Neil to talk about the relevance as it pertains to actual diagnosis and how it compared from one study to the other. I think the answer is there really isn't. Neil, you want to maybe give the clinical answer to that?
Yeah. Very, very small proportion. I think fewer than 10%. We limited very, very much the number of prolonged biopsies incident to the study. What we don't have is the outcomes of those, but we'd never expect them to be any different.
Okay, perfect. Next one is probably fairly simple for you. It just has to do with what are the first conferences as we go into next year, where we might see more complete data?
Yeah. I'll answer that. Obviously there's a number of conferences that I would imagine many of you would be very enthusiastic to get further read on our data, but NKF, the lupus conference in [inaudible] Lupus 2020, will probably be the first ones. There's obviously in the summer, the European conferences, EULAR, ERA, and then to the back end of the year, ASN, ACR.
Okay, perfect. Thank you. My final question just has to do, and I understand these are early days. Given these data, and you've probably been thinking about this if the data were positive, how are you thinking about taking this to the market in various parts of the world? Has it changed at all over the last while in terms of any potential partnerships or working on your own to introduce this in the U.S. market? Maybe you could just elaborate on that a little bit. I'll leave it there. Thank you.
Yes. Thanks for the question. Listen, I think that the company and management team that brought the company to where it is today did a great job at keeping this asset unencumbered globally. It's very rare that you end up with a phase III result and a phase III result like we have with an asset that you've not already sold into other geographies to help capitalize the company. Today, as we sit, this drug is unencumbered in most of the major regions around the world, if not all. Strategically, as a company, though, probably somewhere around 80% of the overall economic impact to the company is going to come from the U.S. market. We have put together a plan to be able to attack the U.S. market, and attack in an appropriate way, and commercialize in the U.S.
Outside the U.S., we have said, in upcoming calls leading up to this, that we would look to potentially partner in Europe, Asia, and Latin America. We'll see where those discussions go. We don't have any intentions of trying to over-dilute our efforts, and we will walk before we run as we move into this next phase of growth. The decision we've made is we can actually go at the U.S. market in a way that would be efficient and effective enough to make a significant impact on our own. As we've said all along, we're wide open to partnership discussions in geographies around the world.
Excellent. Thank you, Peter.
Thank you. Once again, if you do have a question, please press star one on your telephone keypad at this time. Our next question is coming from Umer Raffat of Evercore ISI. Please go ahead.
Hi, guys. This is Mike DiFiore in for Umer. Thanks so much for taking my question and congrats on the data. Very impressive. Just two questions, if I may. I noticed, obviously, in this phase III trial, there were considerably more patients from North America and Latin America. I was wondering how much patients from this geography may have influenced or driven the result. I have a follow-up question after that.
Thanks. As I said before, every single subgroup favored voclosporin. I'll also tell you that the North American subgroup appeared to have a very, very strong loss ratio in favor of voclosporin. Again, we'll be disclosing more of the intimate details of that data at conferences. I think that probably answers that question.
Gotcha. Just in terms of compliance, assuming a best case scenario, assuming that this drug does get approved, lupus patients are among the most noncompliant patients out there. How will labeling speak to that, and how should we think about modeling this drug, just given the notorious noncompliance rate in lupus patients?
Well, listen, we look forward to following up with you on a separate call. Maybe we can get deeper into it, but I think it's early for us to say how we think this could impact compliance, because I think we have to understand compliance more broadly as it pertains to the current treatment paradigm anyway. One thing I will say is, today you don't have companies actively out there promoting to this indication and to this physician group. To have a group of dedicated sales and medical people out there talking to physicians and working on the implementation of wherever our label lands with this drug, if approved, our efforts will only help to make this patient population more compliant. That would be our hope. I look at it as an opportunity.
Understanding, of course, that there is history with this patient population, there is some notorious sort of noncompliance. I look at it as an opportunity to try to provide benefit with our infrastructure as we grow towards helping patients become more compliant with our drug. I think our dosing regimen, in the early stages of dosing of patients, could be quite helpful between the physician and patient interaction.
Got it. Thanks so much.
Thank you. Our next question is a follow-up coming from Ed Arce of H.C. Wainwright. Please go ahead.
Hi. Thanks for taking my follow-ups. I have a couple. First is just a question that I'm sure you've heard many times before. Now that we have the primary endpoint data, 2.65 odds ratio and 18.3% absolute risk reduction, seems pretty clear this is sufficient for approval. How do you see this? What comments are you hearing from treating physicians around this delta and how they may view it? The other question is just around publication of the AURORA results. Do you expect that by launch? How important do you see that in the totality of your early commercial efforts? Thanks.
To answer your first question, I guess the way I look at it, maybe it's an oversimplified way of looking at it. We darn near repeated the efficacy benefit that we saw in the phase II trial. There was very close to a doubling of the effect over the standard of care. I'd almost have to continue to go back to that because we didn't do a true placebo-controlled study here. We did a study versus by adding this additive to the standard of care. We've talked to physicians historically about that, under a profile like this, they are excited about having a drug in their treatment armamentarium like voclosporin. We have to take it through the regulatory process. Obviously, we're not an approved product yet.
We also have to take this phase III data in conjunction with the phase II data and go out and do more market testing with physicians across geographies to better understand that as it pertains to access and pricing. We fully intend to do that. We've done the pre-work. I can tell you that this profile coming out of phase III was sort of our optimistic case in any pre-market work that we did post the phase II study. That coupled with, which was probably our biggest question going into phase III, what would the benefit risk profile look like?
On the risk side of the equation, I think the AURORA study did us a big favor in showing that our safety was quite comparable to that of the standard of care, which is we couldn't have asked for a better outcome there for patients and for the drug in the market space. Ed, can you repeat your second part of that question? I'm not sure. You asked about publication, but as it pertains to what? Neil can probably comment on our thoughts around publication, but you also had a commercial question that was attached to that.
Well, just first of all, the timing, do you expect or intend to have or hope to have that out in publication by launch? How important would you see that in the overall early commercial days, having that available for physicians?
Well, just to answer the question, since we would be looking at an early 2021 potential approval for the drug, if everything goes our way. I'll have Neil comment on if we think we'd have a publication by that time. I can tell you that we would be just fine even if the data was not published with what we have on file. We could easily go out and run with our label and the major medical meetings between now and 15 to 16 months from now. We have several conferences. We have plenty of opportunity to get this data out there to physicians pre-market, and then post it will be part of our label. Neil, you want to comment on the publication strategy here?
Yeah. No, I think we all like to think that we can get these things published quickly, but these things are very lengthy. We're very dependent on the review process by journals, which is something that's completely out of our control. Also, it's never just one publication. Our medical affairs team have been working on a robust communication plan, which includes publications, communications through congresses. These are all going to be thought of very carefully to support the launch of this drug.
Okay. Great. Thanks both of you. That's helpful. Congrats again.
Thanks, Ed.
Thank you. Our next question is a follow-up coming from David Martin of Bloom Burton. Please go ahead.
Thanks for taking the follow-up. I know when you started AURORA, there was contemplation of an exploratory kind of parallel sub-study with patients who agreed to get a post-biopsy as well as the pre-biopsy. I'm wondering, did that parallel study get off the ground? How many patients were enrolled, and when might we see data from that?
Yeah. Thanks, David. This is an important sub-study, but it's also part of the AURORA 2. We don't have any visibility in this ongoing study, the number of biopsies that we've got so far. We certainly don't have any results yet, but they will be reported towards the end of AURORA 2 no doubt.
Okay. Sorry. How many patients opted for it?
Yeah. We don't have that exact number. We can't give you that at this point. The study's still ongoing.
Okay. Sure. Thanks.
Thank you. At this time, I'd like to turn the floor back over to management for any additional or closing comments.
Well, thank you, operator. Thanks to everyone who joined us for the call today. We remain very excited about what's on the horizon for us here at Aurinia. We want to thank everyone for your time and attention. Feel free to reach out to us with any further questions. Thanks. Have a great day.
Ladies and gentlemen, thank you for your participation. This concludes today's event. You may disconnect your lines at this time, and have a wonderful day.