Sage Therapeutics, Inc. (SAGE) Earnings Call Transcript & Summary

May 11, 2022

NASDAQ US Health Care conference_presentation 30 min

Earnings Call Speaker Segments

Tazeen Ahmad

analyst
#1

Good morning. Welcome to Day 2 of the Bank of America Healthcare conference. I'm Tazeen Ahmad. I'm one of the senior SMID biotech analyst here at Bank. It's my pleasure to have our next presenting company here with us, Sage Therapeutics. Sitting with me this morning will be Alan Chris. I'll let you guys introduce yourselves, and maybe, Chris, you could give us an overview -- a quick 2-minute overview of what's been happening at Sage Therapeutics.

Chris Benecchi

executive
#2

Sure. I'm Chris Benecchi. I'm the Chief Commercial Officer at Sage. We show the Chief Scientific Officer of Sage Therapeutics. So first of all, Tazeen, thanks for having us. It's an exciting, and it's great to be here. It's an exciting time to be a part of Sage, and we're off to an incredibly strong start in 2022. When you take a step back and think about what we've already accomplished -- with respect to clinical development, we are planning and executing 6 Phase II studies across our neuropsychiatry and neurology franchises that essentially means that for patients living with essential tremor and mild and cognitive impairment associated with conditions like Huntington's disease, Alzheimer's disease and Parkinson's disease that we believe we have the potential to profoundly affect the way that they live their lives with the therapies that we have. And I'm sure we'll get into that in a little bit of time. I think also, last week, we had some exciting news as well, too. We announced the rolling submission kickoff for zuranolone. So obviously, as you might imagine, we're working incredibly hard on that submission right now. But again, a very important milestone for our organization. And certainly, last but not least, we're amidst commercialization planning with respect to zuranolone for both MDD and for PPD. So a lot of work going into that right now. And again, an incredibly exciting time for both our organization and Biogen, who are collaborators with us for zuranolone as we move forward. And that's all enabled by what really is a strong balance sheet as you think about what we have and our ability to leverage those resources both for clinical development as well as for commercialization as we move forward. So again, as an organization that's really committed to pioneering life-changing therapies for people living with serious brand health conditions, we feel like we're in a great position in 2022 and looking forward to the rest of the year.

Tazeen Ahmad

analyst
#3

Okay. Great. Well, thanks, Chris, for that intro. So yes, maybe let's stay on topic. You started, as you said, by announcing that you're rolling submission was in place last week for zuranolone. Can you tell us what additional steps are still to be completed as this rolling submission happens. A few companies have hit some snags along the way, FDA by perception seems to be becoming a little bit more conservative across the board. I don't know if you, as a team would agree or disagree with that. But one thing that has been a topic of discussion for a lot of companies is where they are on CMC. So can you just give us a summary of what the company has done to prep for CMC issues that might pop up? And just in general, where you plan on doing most of your manufacturing?

Chris Benecchi

executive
#4

Yes. So -- sure. So with respect to CMC, at this point, we've completed CMC development and scale-up. So we're in great shape there. With regard to how we think about the CMC portion of the submission, the team is working incredibly hard on the CMC sections of the NDA. So the idea is that as we complete the CMC sections of the NDA and we have the final submission, we'll come back and we'll provide an update with respect to where we are and once we've submitted all of the modules associated with that as we move forward. So again, I think as an organization, we're doing everything that we can as we think about not just CMC, but the submission overall to really think through what it is that we need to accomplish in order to successfully have a submission and approval as we move forward.

Tazeen Ahmad

analyst
#5

What are the advantages for you in particular to do a rolling submission?

Chris Benecchi

executive
#6

Yes. So I think the rolling submission allows us to get our material in front of the FDA as soon as possible, right, as we move forward. And I think that there's an opportunity as we do that, to continue to provide the modules that we have as we ready them as we move along. So they have an opportunity to review those as we go. So when the submission is finally completed, they have everything that they need. And they've already had an opportunity to look at some of those materials.

Tazeen Ahmad

analyst
#7

Okay. So how are you feeling about the potential for having an AdCom?

Unknown Executive

executive
#8

I got to talk a little bit of that, Tazeen. Thank you, again for having us at the conference. It's a pleasure to be here. So please warm and sunny for a change. We -- the rolling submission is something -- I'm sorry, what was this? The AdCom is a great question. We really don't know whether or not the FDA would require one as they don't tell you until they actually ask for us. But we really look at it as an opportunity to demonstrate and to talk about the profile that zuranolone is and how this differentiates itself from other compounds. We were planning for it in the event that the FDA does ask for us to work, the team is getting ready for it in the event that they do. But it gives us an opportunity to really showcase how this molecule is different to standard of care. We wrap an onset of action for 2017, the durability as well as the utility of an acute therapy, which is very much different from the standard of care that exists now. Those questions are probably ones that are very important. We did have an AdCom for ZULRESSO, as you know, but this is an oral therapy, not the IV therapy. So we expect that they may ask for the same thing.

Tazeen Ahmad

analyst
#9

Yes. So maybe we can touch upon one of the points you just made about the benefits of zuranolone, which is durability. So do you think that the Street fully appreciates the drug's profile? So you are taking a more nuanced view to treating depression, right? So it's chronic disease, but you would like to treat it with first of acute therapy basically, right? So how does the question of durability get answered when you're trying to really treat people over spirts of time?

Unknown Executive

executive
#10

That's a fantastic question and one that we've evolved and learned as we've developed the molecule as well. We believe that patients don't want to be treated forever. You don't think of a depressed patient is now a press patient for life. We believe that depression is a disease, not who you are. What we found out through our clinical studies has been pretty consistent through all the clinical studies that we've conducted, is that a 2-week therapy of this in the vast majority of patients is all that is necessary to put their depression in some phase of remission, bring them to some level of relief from their depression. Will patients go back into depression, that possibility always exists. Because of that question, we started a very complicated and very thorough clinical study called SHORELINE, which is a study that looks at if patients need to be redosed over the course of a year. And we allowed patients to be doses many times as necessarily during the course of the year. And we'll probably talk about it more in depth. But in general, patients in that entire clinical study required only 1 or 2 doses over the course of an entire year. So it's obvious to us that patients don't want to be treated chronically for a year, 2 years or longer on therapy, especially therapies with side effect profiles that aren't necessarily attractive to most patients. And what we found out in that study is they don't need to be. The vast majority of patients require 1 or 2 doses or dose regimens of the 2 therapy.

Chris Benecchi

executive
#11

Yes. I mean I think just as an add-on to what Ed said. All said, I agree with everything that you said. I think from a go-to-market perspective, as you take a step back and you think about it, while there are 21 million people that are expressing at least 1 episode of major depressive disorder on an annual basis, $6.8 million or so were switching therapies. And what that says to us is that this is not a well satisfied market. There are patients that are incredibly troubled by their MDD and they're looking for solutions. And for many patients, sometimes that solution is something that they can take and they can know within 3 days or so that the medication is going to deliver what they want. In other cases, it's to have the efficacy and to really experience it without the stigmatizing side effects associated with other therapies like sexual dysfunction and weight gain. And sometimes, as Al mentioned, it's the opportunity to take a therapy to experience the relief and then not need to redose or retake the therapy for an extended period of time so they can get back to living the lives that they want to live in the absence of needing perpetual therapy.

Tazeen Ahmad

analyst
#12

So in theory, everything you say makes sense, but how do you translate that into an actual label?

Unknown Executive

executive
#13

Well, label discussions are something that we're very much obviously coordinate with the agency in discussing -- the results ultimately done.

Tazeen Ahmad

analyst
#14

Yes. So I guess in ideal world, if you were writing your label, what would it look like?

Unknown Executive

executive
#15

I don't want to speculate on what I'm certainly not the clinician. I'm the science guys. So those label discussions are deep. Obviously, the commercial team is very much involved in that as well as the clinical team but Chris want to say...

Chris Benecchi

executive
#16

Yes. I think from a commercial perspective, a broad label would be advantageous with respect to MD and ultimately with PPD, the opportunity to really have the label reflect what we've seen in the LANDSCAPE and NEST programs. I know we're talking about MDD, but I think it's the same for PPD as well too. I think with respect to the LANDSCAPE program, what we've seen is that patients, whether they are patients that are in need of monotherapy patients that are in the adjunctive therapy or patients that are also potential for co-initiation of therapy that we have the ability to message to the breadth of what we've seen in the LANDSCAPE study and the broadest label possible would enable us to do that. So that's what we look forward to. But I think as Al said, it remains to be seen what comes from the FDA, but we're planning for all scenarios.

Unknown Executive

executive
#17

Our entire clinical program has been designed around gaining the information that helps inform both patients as well as providers, how to dose the drug for various types of depression, whether it's coadministration with an SSRI or an acute therapy or they met need for PPD and other types of depression. So the entire program has been designed around getting that information to help guide what the label would say.

Tazeen Ahmad

analyst
#18

Okay. Now assuming that the drug is approved, upon approval, you will expect to have a 3-month DEA review?

Chris Benecchi

executive
#19

Yes, that's correct. Yes. So essentially, we would expect that from our PDUFA date to the scheduling is approximately 90 days.

Tazeen Ahmad

analyst
#20

Yes. And just for people that are not familiar with that, what does that entail?

Chris Benecchi

executive
#21

Yes. So at the point of PDUFA, DEA will take a step back. And what they want to do is they want to think about whether or not the medication should be scheduled. So DEA when they take that step back, they look at the medical use, and they look at the risk of abuse independence and they'll schedule the therapy anywhere from a Schedule 1 agent, which bears the highest risk of abuse independence all the way out to a Schedule V. I think with respect to what we saw from ZULRESSO and what we would expect with zuranolone as a Schedule IV agent, which essentially means that there is strong medical use for the product and low risk of abuse dependence associated with the therapy. And again, it's quite common in the neuropsychiatry space for agent to be schedule if you will as you move forward. So in that 90-day period, we have an opportunity to continue to engage with all stakeholders as we think about what it's going to take to effectively prepare while the DEA schedules the medication over the course of that 90 days.

Unknown Executive

executive
#22

And all the studies necessary to help guide the agency with that decision-making process have been completed in regards to zuranolone. So to the rest, it was a schedule for compound, and we expect that we probably will see some see something similar as we see similar adverse event profile.

Tazeen Ahmad

analyst
#23

Okay. And then, I guess, a real-world setting, what does that end up meaning for your ability to market the drug coverage for formulary if any effect at all?

Chris Benecchi

executive
#24

Yes. So you don't have final label until you have DEA scheduling. So what we'll continue to do is we'll continue to engage with stakeholders in the way that we will leading up to the PDUFA date. So we'll continue to be actively engaged with payers, for instance, whether they're national or regional payers, PBMs or IDNs in and around the data that we've seen in this case, from the LANDSCAPE program, and we'll continue to prepare, if you will, for our commercialization once we have DEA scheduling. And what that will mean is that we'll shift our activities from really being out in front of clinicians and making sure that we understand them and their treatment practices to ultimately with DEA scheduled, then the ability to promote the product. So we'll be out, we'll be engaged and we'll be ready to go when the product is all the way scheduled.

Tazeen Ahmad

analyst
#25

Okay. So maybe another question on commercial opportunity for you. At least initially, where do you see zuranolone fitting into the treatment paradigm? Because MDD is complicated. There's like a very wide range and type of patient profile. As you strategize about what you want your areas to focus to be on initially, can give us some guidance as to what proportion or where in the population you think ideally the drug would have strong initial update?

Chris Benecchi

executive
#26

Yes. It's a great question and one that we obviously think about quite a bit. With respect to what we've seen, as I said, in the LANDSCAPE program, we know that the medication works as monotherapy. We know that it works as an conjunctiveness. As I mentioned from CORAL, we also understand that there's an opportunity to co-initiate the therapy with other therapies like an SSRI. So taking a step back, a lot of the work that we've done has been to engage with clinicians to understand over the course of months leading up to today, and we'll continue to do this as we continue to progress through to approval to understand how clinicians ultimately will use the product. And what we see is that there is a wide degree of use desired by the clinicians that we engage with. There are some physicians that will want to use it out of the gate as is an adjunctive therapy. Others that will want to use it as monotherapy and others that may actually try and go ahead and try it is a therapy that they co-initiate. I think for us, as an organization, what we really need to focus on is making sure that with respect to the work that we do, we do everything that we can to move zuranolone up into the line of therapy as soon as possible. So patients are not stepping through 1 therapy to the next before they get to us. And the breadth of what we would expect with respect to the clinical data and the label would give us the opportunity to move up earlier into the process of physicians experiencing medications or trying medications before they move patients on -- onto another one. As I said, there's 6.8 million patients that are currently not satisfied in the market. And we know that for zuranolone, a number of those patients are very right for our medication. So I believe there's broad and specific opportunity for us as we look forward.

Tazeen Ahmad

analyst
#27

And what's the feedback been from physicians when you speak to them about the profile of the drug? And then how they intend on using it?

Chris Benecchi

executive
#28

Yes. So the feedback has been great. I think in terms of what we hear from physicians is the idea of being able to send a patient home with a solution that in 3 days that they know if the medication works or not, is game changer with respect to what they currently have available. Over the course of the last 30 years or so, I think there's been 35 new medications. And even as you step back further from that, if you think about the last 60 or 70 years, there's not been a lot of innovation. There's been a lot of sameness in this space and the mentality has been treated to fail. The opportunity to send someone home with a product that they know in 3 days works, and that they can take over a short course that has lasting effect, as Al mentioned, with respect to the SHORELINE data with 80% of patients effectively being able to go 1 year, which has 2, 2-week courses without the tolerability profile that you see with other therapies like sexual dysfunction and weight gain. It's a profound game changer for them. And there's a lot of excitement about early use in getting the product to try as we move forward.

Tazeen Ahmad

analyst
#29

So some of the questions that I get, everybody fully agrees that this is a fast onset of action drug, and that in and of itself is important and needed for patients. But there is also the deal that perhaps one of the options that Sage might have is to approve the drug for [ Resona's ] induction therapy. So allow the patient to feel better really quickly and then switch them to something more traditional generic drug that has by itself a shorter time spans to provide efficacy, I don't know, what is it an average of 3 months that it takes to show some level of improvement.

Chris Benecchi

executive
#30

Typically 6 to 8 weeks with SSRI therapy.

Tazeen Ahmad

analyst
#31

Yes. So what is your view of FDA in considering such a thing? Is that even on -- would that even be on the table?

Chris Benecchi

executive
#32

Well, lot reason why we did the call CORAL study. The CORAL study was the study where we coinitiated the use of zuranolone with an SSRI to see if there was that rapid onset of activity. And what we saw with CORAL was exactly what we've seen with every other study, a rapid onset of activity of the molecule and durability out to 2 weeks. Once you stop, you're taking the drug. The effects are still there at the end of the 42-day period. So we're seeing very much what we saw in all the other studies. There are going to be some physicians who would probably want to treat their patients after the 2 therapy with a follow-on an additional SSRI or additional antidepression therapy. And for that reason, that's one of the reasons why we did that trial, to help inform both us and the providers and patients of what their actions are in being treated for depression. So I think what we have is a data set that allows us to administer the drug in a lot of ways. And ultimately, what will happen is people start experiencing the differentiation of this molecule relative to standard of care, they may start adapting how they treat their patients. And for a physician is going to be up a patient by patient so there's no doubt. It's going to be -- they're going to consider their patient's past history as well as how they respond to this therapy.

Tazeen Ahmad

analyst
#33

If doctors have that level of flexibility in choosing how they want to prescribe zuranolone, doesn't that make it complicated in how you think about pricing the drug?

Chris Benecchi

executive
#34

So with respect to pricing, I mean, obviously, as you might imagine, we're active and engaged with payers right now. And I think those conversations have been incredibly valuable and productive and instructive with respect to how we think about pricing the product. I think with respect to what we see in and around the pricing of products, we have a sense for the range within which we need to think about how to price a rent alone as we move forward and what it will take in order for payers to adopt the medication. So with respect to how we think about pricing, though, it's really been a conversation that we've had with payers. I think physicians will use the product independent of what the price is of the product. I mean, obviously, how the payers ultimately choose to reimburse or cover the product has some benefit, but the physicians themselves aren't thinking about the price. It's more of a payer dialogue that's happening in and around how we make sure that there's access to the product.

Tazeen Ahmad

analyst
#35

Okay. So maybe taking a little bit of a more deep view about the market opportunity. What do you think the patient awareness is of zuranolone right now? Obviously, you can't detail to anybody, but do you think that initially you can rely upon patients that were in your clinical studies to be sort of the first users of the drug? And what kind of a slope of uptake should we really be expecting? Because it is certainly paradigm shifting and differentiated, but it is not a rare disease drug, right? It's going to be launching into a very large market. And even with your partner on board, how do you think about the dynamics that are going to be in play in the initial portions of your launch? What are going to be the rate-limiting factors?

Chris Benecchi

executive
#36

Yes. So I think with respect to how we think about commercialization for zuranolone, but let me provide a little bit of a broader perspective on that. I think as an organization we acknowledge that we need to take an omnichannel approach to how we effectively reach this marketplace. This is an incredibly large market with respect to the number of patients and the number of prescriptions. And the number of clinicians that are actually writing prescriptions for patients with depression. I think with that being said, we know that there's going to be effort that is largely focused on physicians. There's also going to be effort that's going to be focused on patients and other stakeholders like payers and policymakers as we move forward. So with that being said, patients will play an important role in what we do once we're approved in terms of our ability to directly message to them in and around zuranolone and what it potentially offers relative to other therapies that they may have experienced in the past. I think right now, we're continuing to build our efforts in and around preparing for our go-to-market. And so as it stands right now, there's not a lot of effort, as you note, around educating patients about zuranolone. But what we are engaged in is working with patient groups and really educating around the need for innovation in this space and the opportunity that therapies could offer in and around how to change the mindset about what current therapies offer and what new therapies may offer in the future. So that disease state awareness effort is just beginning to kick off right now. But again, it's going to play an important role in our omnichannel efforts and specifically, it's going to engage in a number of the patient groups that are out there in support of those patients.

Unknown Executive

executive
#37

There was a clear need for differentiated medicines in mental health. The pandemic has told us anything is that mental health is definitely a pandemic in and of itself in the United States as well as the world today. And patients are looking for other opportunities to treat their diseases where either they're not getting the effects that they want from the current standard of care or they're looking for something with a different side effect profile.

Tazeen Ahmad

analyst
#38

So if you think about the size of the market, where do you think the ideal -- or where do you think it could peak in terms of market share? And how have the interactions with Biogen been going as you inch closer to becoming commercial with the drug?

Chris Benecchi

executive
#39

Yes. So it's early to talk about market share. Obviously, as I mentioned, there are 6.8 million unresolved MPD patients that are out there currently as we speak. And we see our opportunities being squarely in that group of patients for us to really have the opportunity for them to experience something that is profoundly different than anything they've experienced before. So with that being said, as I said, it's a little early to talk about market share. And then around the partnership with Biogen, I think that collaboration has gone incredibly well. They are an active and an engaged partner. They are as determined as Sage to make a profound difference in the lives of these patients that are living with MDD and PPD. And it's been a really strong collaboration out of the gate. I think right now, what we see is, is that not only is it a priority for us, but it's also a priority for Biogen as well, too, with respect to the therapies that they have in their portfolio or in their pipeline. With that being said, in terms of the activities that are ongoing right now, there's a lot of activity around continuing to deepen insight into the marketplace and deepen insight into the stakeholders that are currently engaged in the treatment of depression and postpartum depression and to continue to evolve the strategy and the go-to-market plan that will effectively allow us to reach those patients with both MDD and PPD. So more work to be done, but the partnership has gone incredibly well.

Tazeen Ahmad

analyst
#40

So they launched [ Angie Home ], which probably has not gone as well as they would have initially anticipated. And so they had to make changes to their commercial structure. Is there any concern that those changes that they've made there may impact the structure of how the sales force would look like for zuranolone?

Chris Benecchi

executive
#41

So no concern in and around out at Home. I think the go-to-market efforts is we're continuing to frame out right now, are still being, as I said, framed out or built up. So that impact of [ Angie Home ] doesn't have impact on zuranolone as we move forward. What I can tell you is that the same partners that we had at the beginning of this and the collaboration remain the same people that we collaborate with today, and they are strong commercial leaders, strong marketeers, strong sales leaders. The breadth of the talent that they bring has been really strong from the very beginning. So we'll continue to look forward to working with them as we move forward.

Unknown Executive

executive
#42

And as there is such a need in the mental health field as well, there is -- as we mentioned, again, there are definitely needs in the areas of cognitive impairment in Alzheimer's disease. And we have a very deep program in there as well as the whole NDA platform for Sage, turn around SAGE-718 is one that we're equally excited about advancing the company forward and taking that clinical program forward as well.

Tazeen Ahmad

analyst
#43

We'll talk about that in a minute, but just to wrap up on commercial. How big is the commercial footprint going to be between the 2 companies? And as we stand, have has the hiring process started for field force?

Chris Benecchi

executive
#44

Yes. So it's still a bit premature to put a number on what it is we're going to do with respect to field sales force, and we're working on that currently. As I mentioned, it's really important for us to think about this from an on a channel perspective. So whether it's the sales representatives that we have in the field or it's the way that we think about engaging clinicians digitally or patients directly through digital mechanisms for payers. We're still building that out as we go. But we do know that in this space that -- we really want to be thoughtful about what we do. We really want to use our resources wisely. And the mentality is to think big but it's to start in a focused way and to scale quickly with respect to as we see green shoots of uptake in the marketplace and to adjust the approach that we take. So that's the real approach that we're taking right now as we move forward.

Tazeen Ahmad

analyst
#45

Okay. Let's talk about PPD for a minute before we move on. So how is that treatment regimen going to differ from the treatment regimens adjusted for MDD? And can you just give us a sense of how big that market opportunity will be?

Chris Benecchi

executive
#46

Yes. So -- sure. In terms of the size -- let me start with the size of the marketplace. We know that 1 on an 8 moms suffering from PPD. I think when you begin to peel that back and you start to think about those that are actually diagnosed, it's in the range of 500,000 or so moms that are living with postpartum depression across a variety of different severity scales associated with that. So we know that there's significant opportunity in PPD in order to reach those moms with zuranolone. In terms of the number of courses of therapy, as Al mentioned, with SHORELINE, we know that there are patients that 80% or so need 2, 2-week courses over the course of a given year. It may look a little bit different in postpartum depression with respect to the number of courses of therapy, or maybe 1, 2-week course that they need.

Tazeen Ahmad

analyst
#47

Okay. And how would pricing for PPD indication work relative to MDD?

Chris Benecchi

executive
#48

Yes. So the way that we're thinking about it, and again, we're active and engaged with payers on this topic right now. We would price it the same across PPD as we do for MDD, at least that's the thinking that we have as we continue to engage right now. So the idea is that you shouldn't charge more for a mom living with PPD than you would for someone with MDD, nor the other way around that. We want to make sure that people have the equal opportunity to access the product for the price.

Unknown Executive

executive
#49

And there are even less choices in the field of PPD for patients suffering PPD than they are for MDD. They're -- ZULRESSO is the only approved drug for PPD currently.

Tazeen Ahmad

analyst
#50

Okay. And will the dosing be the same?

Unknown Executive

executive
#51

Yes, the dosing regimen for PPD be same treatment as it would be for MDD.

Tazeen Ahmad

analyst
#52

Okay. So let's move on to the pipeline. And maybe you can give us a little bit of an overview of 718 since...

Unknown Executive

executive
#53

Sure. I think we're sort of pressing up against a little bit of time, but I'll try to highlight as quickly as I can. SAGE-718 is our first NMDA positer modulator in the area of the glutamate side of the house. It is -- we're very much excited about that as we are about the GABA platform. We've initiated a very thorough clinical examination of the effects of SAGE-718 in a number of different diseases associated with cognitive impairment, beginning with Huntington's disease, looking at Parkinson's disease as well as Alzheimer's disease. And just -- I can briefly say that we've done open label studies in all of those diseases, and we've shown the effects of 718 on those 3 different diseases. And what we're seeing, thankfully, is a very similar effect on executive function and cognitive performance that is very much unlike what a lot of other companies are looking at today. We're looking at improving synaptic function and we're looking at improving the brain circuitry associated with cognitive decline. What we're seeing in a very short amount of time is improvements in, as I said, executive function and cognitive performance. That really encourage us about the utility of this molecule, not just any specific type of neurogenic disease but across a platform of diseases that have cognitive impairment as sort of a common alloy amongst them. We're starting with our Huntington's disease placebo-controlled study now both with 2 different studies looking at surveyor and dimension where we're looking at. And we're recruiting now for patients suffering from Huntington's disease, a cognitive impairment associate with Huntington's disease. And those studies are ongoing right now. We also will be initiating soon thereafter a study in Parkinson's disease as well as a study in Alzheimer's disease.

Tazeen Ahmad

analyst
#54

Okay. So these are all potentially very large indications and also famously difficult to drug. So for Huntington's, how do you think about the use of biomarkers? And how are you going to think about whether you're getting efficacy to support disease modification or if it's more going to be symptomatic control is your goal?

Unknown Executive

executive
#55

So we see this as modifying the disease pathway. We're ultimately improving synaptic function or believe that we would be improving synaptic function of patients suffering from a cognitive impairment. One of the first things we did was we did a Huntington's disease trial where we looked at patients that were deficient in what we believe to be the endogenous neurochemical that actually activates [Indiscernible] receptors. One of the things that company did very, very early and working closely with Washington University, we identify what we believe to be the native ligand in your brain that activates a [Indiscernible] receptor molecule 24-hydroxy cholesterol, that molecule like allopregnanolone isn't very good drug-like molecule. It doesn't have good oral bioavailability. It's not -- it doesn't perform as you would want with a normal drug. So what the team did was identify synthetic compound that has very similar pharmacology but has much better drug-like properties, and that is SAGE-718. And that molecule was something that we developed a number of years ago and we brought forward. So we do believe that we'll see significant effects similar to what we did with Huntington's disease. The first patient population we looked at was deficient in that 24-hydroxy cholesterol. And what we saw was improvements in executive function and in memory performance in a very short span of time in that patient population, that data associated with the data that we got in both Parkinson's and Alzheimer's encourage us to make our first entry in the placebo-controlled study into the Huntington's disease patient population.

Tazeen Ahmad

analyst
#56

And It's too early to tell. But what kind of data would you want to see in terms of efficacy to make it feel like it's clinically meaningful?

Unknown Executive

executive
#57

When we're looking at a number of different scales, obviously, I was looking at MoCA as the scale of looking at cognitive performance. And what we've seen early on is we've seen a significant improvement in the MoCA scale in patients taking 718 in a very short amount of time. The study that we have -- the 2 studies that we have going on right now, we'll look at the longer-term effects of that molecule on cognitive performance and on executive function as well as how that improvement or potential improvement in their efficacy translates to real-world activities. And those are the 2 studies involved with 718 right now. So working closely with the agency, obviously, around what that would look like and ultimately, as we evolve the study, we'll develop those.

Tazeen Ahmad

analyst
#58

Okay. Any guidance on roughly when we could see that data?

Unknown Executive

executive
#59

The data we are recruiting for that -- for those studies, and we just started recruiting for the studies this year. I think as the cadence of those studies start to evolve and we get more and more patients and we'll have a better understanding of what the recruitment level looks like and how quickly we'll be able to do that, and we'll report that in the near future.

Tazeen Ahmad

analyst
#60

Okay. Perfect. I think with that, we're out of time. So thanks so much, Al and Chris, for joining us here at the conference, first time live in 3 years. So I appreciate you making the trip. And thanks, everybody, for joining us.

Unknown Executive

executive
#61

Thank you.

Chris Benecchi

executive
#62

Thank you very much.

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