Greetings and welcome to the Aurinia Pharmaceuticals Aurora Clinical Trials Results Conference. At this time, participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr.
Glenn Schulman, Head of Investor Relations. Thank you. You may begin.
Thanks, Donna, and 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 Doctor. Neil Solomons, Chief Medical Officer.
Last night, we issued a press release detailing the results, which are available on our website at www.iriniapharma.com, along with the six ks 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 and 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 Authorities and reports that we file on Form six ks with the U. S. Securities and Exchange Commission. All of the statements being made during today's call are as of today, 12/05/2019, and based upon information currently available to us.
Except as required by law, we assume no obligation to update any such statements as of this date. With all of that,
let me turn the call over to our CEO, Peter Greenleaf. Peter? Thanks, Glenn, and 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 to 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 the patient's kidneys, 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. So 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 showed 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 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, would be important to remind everyone on the call that our clinical team is in the midst of executing on a Phase twothree 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 two 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 twothree AUDREY trial in the 2020, another potential advancement for patients and for Aurinia's overall growth.
Lastly, we're 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 2020 as well.
If it's not obvious, this is a very exciting time for our company. So without further ado and with that quick introduction by me, I'd like to now turn the call over to Doctor. Neil Solomons, one of our founders and a Chief Medical Officer of the company to provide you with further details from the AURORA trial results. Neil?
Thanks, Peter. So this slide shows you a quick reminder of the AURORA study design. Three fifty seven subjects with biopsy proven proliferative membranous or mixed active lupus nephritis with a proteinuria of at least one point five 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 two point five milligrams of prednisone by week sixteen. In addition, subjects administered either voclosporin twenty three point seven milligrams twice daily or placebo in a double blind fashion.
The primary endpoint was renal response at fifty two weeks defined as a urine protein creatinine ratio or UPCR of 0.5 or less in the presence of low steroids, stable or normal renal function and no rescue therapy. Secondary endpoints included renal response of twenty four weeks, partial response at twenty four and fifty two weeks, time to UPCR of less than or equal to zero point five 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 fourteen percent of subjects with pure CAS5 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. However, patients self reported as black constituted approximately fifteen percent of AURORA participants and 40% of U. S.
Subjects. In addition, approximately one third of AURORA subjects were Hispanic or Latino. We believe that this is representative of The U. S. Population.
So now we're going to go over the efficacy. The primary endpoint was met in the study with a fifty two week adjudicated renal response rate of forty point eight percent in voclosporin treated patients versus twenty two point five percent in the control. That represents an odds ratio of two point six five 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. This study was internally consistent.
With respect to the secondary endpoints, renal response was also assessed at twenty four weeks with thirty two point four percent of voclosporin subjects versus twenty percent of the control arm achieving renal response to twenty four weeks. This is an odds ratio of two point two three with a p value of 0.002. More secondary endpoints, the partial response rates of twenty four weeks were seventy point four percent in voclosporin versus fifty percent in the control arm, odds ratio of two point four three with a p value of less than 0.001. At fifty two weeks, the partial remission rates were sixty nine point eight percent in voclosporin versus fifty one point seven percent in the control arm with NOS ratio of 2.26p less than 0.001. Our assumption at this point is that between week twenty four and week fifty two, 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, renal response at twenty four weeks, partial response at twenty four and fifty two 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 prespecified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin. This next slide looks at the reduction in proteinuria.
In addition to hierarchical secondary endpoints voclosporin also resulted in profound reductions in proteinuria at fifty two 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 twenty one point three control arm subjects compared to twenty point eight percent 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 fifty two weeks. So in conclusion, the strong risk benefit observed in AURORA confirms the treatment effect seen in the AURORA LV trial when comparing voclosporin twenty three point seven milligrams twice daily combined with background standard of care versus standard of care alone.
The odds of achieving renal response on voclosporin therapy are 2.65x greater than on control, while maintaining a favorable safety profile. The absolute risk reduction was eighteen point three percent. Substantial efficacy benefit for proxylsthorin was achieved without any observed safety penalty of control. So
thanks, Neil. And before opening up to Q and 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. And 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.
And with that, I'd like to turn the call back to the operator and open the line for Q and A. Operator?
Thank you. 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. So I look forward to this maybe being the first approved lupus drug. So I've gotten a of questions overnight about your IP situation. So 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 like kind of 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 twenty four weeks versus other CNIs as well. 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 and 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. And 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 use both in the Phase two and the Phase three trials, method of use patent that was issued that takes the intellectual property portfolio all the way out to 02/1937.
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, we'll just continue to strengthen our method of use patent, but more to come there. Neil, do you want to talk a little bit about rapidity response data?
Yes. So with the AURORA 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 mean, 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. But I would say that our results are comparable with our oral Phase II results.
And then I'm sorry, go ahead.
Before you jump on to 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 etcetera, we hope will get us to a point where patients value our services commercially. And then 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. And 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. But more to come as we roll out our commercial strategy.
You had other questions?
Yes. So in your conversations with docs like what's the strongest argument for voclosporin when there's generic C and I available? And my second one is just, are there any reads to make the FSGS on this?
So I'll start. I'm not sure I understood the last part of the question, but 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. And I would say that their utilization in most markets around the world is quite limited, maybe excluding Asia, but 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 C and Is 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 C and Is today and we'll continue to hammer that message both medically, clinically and commercially as we drive the Pokrif product into the marketplace. But do remember this is a different drug. It's a next gen C and I 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 mean, 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 oxford compared to other CNIs, I think, tell the same story.
And you had a question on FSGS.
Yes. Just looking at obviously the impacts on the kidney and inflammation in proteinuria, like is there any read to make on like 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 C and Is are used broadly in FSGS today. I don't know if that's universally true. They are used. But Neil, you want to maybe talk a little bit about our confidence here and why?
Yes, sure. I mean, calcineurin inhibitors are known to be a good antiprotein drugs. There's a couple of reasons for that. Obviously, the profound immunological effect, but also the effect on the stabilization of the podocyte, which is bodes very, very well for the treatment of FSGS, which is a disease characterized by podocytopathy.
Great, thanks. Congrats again.
You.
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. So a couple of questions here. I guess you've already spoken to the speed of effect and your intent to give more fulsome analysis at a future medical meeting.
But 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 thesis that even beyond fifty two weeks, there is a potential here for increased response on the drug longer term? And then I have a follow-up. Thanks.
Neil, you want to go?
Sure. I mean, so I think the first thing to say is that the ongoing extension AURORA extension study is blinded and is ongoing study. So we don't have any insight into that data. However, I take your point, Ed, the improving response over time. I think that's certainly a hope that we're going to see that.
The other thing that is also going to be very important from us is cementing the long term safety of this drug, which we've seen in other indications.
Great. So and then going back to the question of IEP, I too had a couple of questions about that overnight. And as you know, I did some work earlier in the year around this and we've talked about this. And I guess I just wanted to for all of us to remind you or 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 Aurinia or excuse me, the AURA study, and primarily around the safety.
And so perhaps you could give a little background around that as well.
Well, I think the method of use and composition of matter patents and their timing, went through earlier. So 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 to light here. Maybe, Neil, you can just talk a little bit about that.
Yes. I mean 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 change as well. And that complex modeling fed into a dosing protocol, which we discussed together obviously with supporting data with the FDA.
And that's what made it into the protocol. We're really pleased to see that it actually worked in both protocols.
Great. Thanks again.
Thanks, Ed. Thank you.
Thank you. Our next question is coming from Joseph Schwartz of SVB Leerink. 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, but 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. But 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 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. And 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. And then 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 an adequate response to CellCept and how much before?
I mean, we've had quite a bit of discussion about this around the table. And again, I don't want to hedge on an answer there, but we've got to go out sort of put this data in front of clinicians and I look forward to Neil's answer if he's got a different one here. But I mean 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?
But 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, 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 give voclosporin into the mix of the guidelines. Again, the steps for us are first, we got to get this in front of the FDA, get a robust dossier together for the NDA and then work on labeling.
And then 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. I mean, 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 MFAT screening, those were not on MFAT 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. So I would say that needs to added into our decision making of physicians too.
Great. That's helpful too. Thanks. And maybe one quick one. To what extent have you confirmed with the FDA that the AURORA trial can suffice as a single Phase three or perhaps combined along with data that's replicate from the low dose arm of aura as another Phase III?
Yes. So I'll answer that. 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 and that AURORA should be looked at as confirming the results of AURORA. So yes.
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? Yes. So 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. And how about the AEs leading to discontinuation? Can you give kind of 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. And then the last question, from the extension trial, when will we see the first data? Will you report at twelve months and then at twenty four? Are you going to wait for twenty four months?
So with respect to the ASCENTION trial, this continues as a double blind study. So 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 at safety. That was a request from them in our one hundred and twenty day safety follow-up.
Okay. Thanks and congratulations again.
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?
Yes, I'll answer that. I mean, main driver of efficacy was proteinuria indeed in this study similar to the AURORA trial.
Okay, great. And then maybe 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 five or with Class five involvement?
I'm just Can 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. I'm just wondering if that those subgroups with respect to class and looked at sort of Class V or how class was compared?
Yes. So what we did fairly crude division of biopsy, where we looked at pure class five because that consists of slightly different histology to the others versus non class five. And there was efficacy benefit for voclosporin in both those groups.
Okay, great, great. And maybe just a final one. I know that you are working towards the regulatory filing and that it has been a rolling process. So can you maybe comment on sort of which modules have already been completed and sort of which you expect to be sort of the maybe gating ones in the first half of next year?
Yes. I mean, as I've said since the day I've walked into the company, I've been very impressed by the preparedness of 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. So 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 and everything is on target right now to do that. So the team has been doing a great job and they've been working their tails off doing it. And obviously I thank 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 Doug Miehine of RBC Capital Markets. Please go ahead.
Thanks. I just wanted to follow-up on the biopsy question. It was one of the differences between the AURORA trial and AURORA with respect to the timelines available for those biopsy patients. My question is, were there any difference is in outcome versus those that met the Aura criteria versus the new criteria that were sort of used in the AURORA trial?
So thanks for the question. I mean we get this one quite a bit 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. And if a patient has had to have a biopsy within the last six 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 two year window is much more commercially relevant. I'll ask Neil to talk about the relevance as it pertains to actual diagnosis, but and how it compared from one study to the other. I think the answer is there really isn't.
But Neil, you want to maybe give the clinical answer?
Yes. What we don't have at this point is the actual outcome They're a very, very small proportion, I think, fewer than ten percent. We limited very, very much the number of prolonged biopsies entered into this study. What we don't have is the outcomes of those, but we don't we've never expected them to be any different.
Okay, perfect. Next one is probably fairly simple for you. It just has to do with the what are the first conferences as we go into next year that where we might see more complete data?
Yes. I mean, I'll answer that. So I mean, there's a number of conferences I would imagine, many of you are very enthusiastic to get further reading our data, but NKF, the Lupus Conference in Dust and Roll Lupus twenty twenty will probably be the first ones. And there's obviously in some of the European conferences, EULA, ERA and then to the back end of the year, ASN, ACR.
Okay, perfect. And then my final question just has to do and I understand this is early days. But 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 the company and the management team that brought the company to where it is today did a great job at keeping this asset unencumbered globally. So it's very rare that you end up with a Phase three result and a Phase three result like we have with an asset that you've not already sold into other geographies to help capitalize the company. So today as we sit this thing is this drug is unencumbered in most of the major regions around the world if not all.
So 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 the appropriate way and commercialize in The U. S. Outside The U. S, we have upcoming calls leading up to this that we would look to potentially partner in Europe, Asia and Latin America and 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.
And 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 significant impact on our own. But as we've said all along, we're wide open to partnership discussions in geographies around the world.
Excellent. Thank you, Peter.
Thank you. Our next question is coming from Umer Raffat of Evercore ISI. Please go ahead.
Hi guys. This is Mikey Furey 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, this Phase III trial, there were considerably more patients from North America and Latin America.
And I was wondering how much patients from this geography may have influenced or driven the result? And I have a follow-up question
after that.
Thanks. As I said before, every single subgroup favored voclosporin. And 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.
Got you. And just in terms of compliance, I mean, assuming a base case scenario, assuming that this drug does get approved, lupus patients are among the most noncompliant patients out there. Will this how will labeling speak to that? Will this how should we think about modeling this drug just given the notorious noncompliance rate in lupus patients?
Well, I mean, listen, we look forward to following up with you on a separate 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. And 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 will only help our efforts will only help to make this patient population
That would be our hope. I look at it as an opportunity. Understanding of course that there is history with this patient population and there is some notorious sort of non compliance. 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. And 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. So first is just a question I'm sure you've heard many times before. Now that we have the primary endpoint data, two point six five odds ratio and eighteen point three percent absolute risk reduction seems pretty clear this is sufficient for approval. How do you see this what comments are you hearing from physicians, treating physicians around this delta and how they may view it?
And then the other question is just around publication of the AURORA results. Do you expect that by launch? And how important do you see that in sort of the totality of your early commercial efforts? Thanks.
Well, I mean, to answer your first question, we I guess is the way I look at maybe it's an oversimplified way of looking at it. We darn near repeated the efficacy benefit that we saw in the Phase two trial. There was very close to a doubling of the effect over the standard of care. I mean, 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 and 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 three data in conjunction with the Phase two data and go out and do market more market testing with physicians across geographies to better understand that as it pertains to access and pricing and we fully intend to do that. We've done the pre work.
But I can tell you that this profile coming out of Phase three was sort of our optimistic case in any pre market work that we did post the Phase two study. That coupled with which was probably our biggest question going into Phase three, what would the benefit risk profile look like? And 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, timing, do you expect or intend to have or hope to have that out in publication by launch? And how important would you see that in the overall early commercial days having that available for physicians?
Well, I mean, just to answer the question, since we'd be looking at an early twenty twenty one 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, but 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 fifteen to sixteen 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. But Neil, you want to comment on the publication strategy here?
Yes. I think we all like to
think that we can get these things published quickly, but these things are very, 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 not just never just one publication. Our medical affairs team have been working on a robust communication plan, includes publications, communications through congresses, And
these
are all going to be thought of very carefully to support the launch of this drug.
Great. Thanks both of you. That's helpful and 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 substudy 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?
Yes, thanks David. I mean, this is an important sub study, but it's also part of the AURORA two. So we don't have any visibility into 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 two, doubt.
Okay, sorry. How many patients opted for it?
Yes. We don't have that exact number. We can't give you that at this point. The study is 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.
Thank you, operator, and thanks to everyone who joined us for the call today. I remain 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 and feel free to reach out to us with any further questions. Thanks and 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.