Okay. We'll go ahead and get started with the next one. I'm Ben Burnett, biotech analyst at Wells Fargo. Pleased to be here with Tucker Kelly, CFO of Xenon Pharmaceuticals. Tucker, thank you.
Great. Thanks for having us, Ben. We appreciate it.
I think maybe just to kick us off, maybe give us a brief overview of Xenon and give us what is the sort of key message you're giving investors now?
Yeah, no. We are an ion channel drug discovery and development company, and on our way to becoming a commercial company. Our lead asset is called azetukalner. We completed the second of our registration studies earlier this year, the X-TOLE2 trial, in focal onset seizures. And we've got it to filing this month an NDA. It'll be the company's first, that'll allow us to commercialize here in the U.S. A really incredible medicine that's got an unmet need in focal onset seizures, and really allows us to make that transition from being a discovery and development organization on through to commercial here in the U.S.
Beyond that, we are looking to expand opportunities for azetukalner in neuropsychiatry, and we have got a really exciting earlier stage pipeline of phase I assets in pain, another Kv7 mechanism drug, which is the same as azetukalner for epilepsy, as well as a Nav1.7 inhibitor as well. Those are both in phase I studies in SAD/MAD. We are going to achieve the goal, hopefully, this time next year, late 2027, of becoming a fully integrated biopharma company, and with a real exciting pipeline behind it.
Fantastic. Obviously a busy time for Xenon, and I think especially right now, there is the European Epilepsy Congress going on, and then we have AES coming up in a few months. I guess, do you have a presence at the European conference and what has been the presentation?
We do. We have got a team of a couple dozen people in Athens, Greece this week. The conference is just finishing up. It is the major medical meeting for epilepsy, as you said, in Europe, and then AES is the one here in the States. Yeah, we had a really great presence at EEC. Feedback from the team that I have gotten has been really incredibly positive. We had six posters and presentation. We had an oral presentation, which was an encore presentation of the phase III data from X-TOLE2 that Dr. Jacqueline French presented, and some really great feedback on the panel discussion there. It is always great to kind of broaden the understanding and awareness of the drug.
We get some great feedback from Dr. French and some of the other KOLs who are on the panel, giving some updates and anecdotal evidence that they have from their patients about how well they can do on azetukalner. It is a novel mechanism. It has got a lot of ease-of-use attributes, and it is going to be a really important addition to the armamentarium for these physicians. We had a variety of other posters as well. We had one on the mechanism, the Kv7 mechanism for azetukalner, and how that can combine with other ASMs. Oftentimes, for patients who are not well controlled, they are on polypharmacy, so they are typically on multiple anti-seizure medications, SV2A blockers, sodium channel inhibitors, but there is no other Kv7 potassium channel modulators out there.
We showed that the synergy in combination with potassium channels, with SV2A inhibitors, sodium channels can be really profound for patients as well. We talked about things like ease of use. One of the other benefits of azetukalner is that it is a drug that doesn't need to be titrated. We have doses from 10 mg up to 25 mg, but all of them are at efficacious doses, and that's unlike a lot of other anti-seizure medications. We had some data talking about the patient and physician experience, where patients get really nervous if they're on a drug that requires titration. They're very scared of having another breakthrough seizure. It's a really traumatic event for them, and so the idea that they're on a subtherapeutic dose of a drug can be really challenging.
I think it really highlighted the unmet need for azetukalner, the novel mechanism, the benefits of the ease of use that it comes with it, and then again, these kind of anecdotal stories from the clinicians who've worked with the drug in their hands and how impactful it's been for their patients.
Very cool. I think, with the NDA filing being imminent, maybe if we could project forward and just think about what the potential label could look like and specifically, what doses do you expect would be on the label, and what is the evidence that would maybe support some of the lower doses being included?
Yeah. ASM anti-seizure medication labels are pretty standard in terms of what the indication is. It'll be for kind of broadly for focal onset seizures. It wouldn't be relegated to a particular line of therapy or prior exposure. But as you said, beyond that, we're hoping to have four doses. We studied in the two registrational trials, the phase IIb. There we studied three doses, 10 mg, 15 mg, and 25 mg. 10 mg, 15 mg Oh, sorry. 10 mg, 20 mg, and 25 mg. In the phase III study, we had 15 mg and 25 mg. So we've got a really robust data set across four different doses, and what we see is that across all four doses, we've got good efficacy. So there's a very strong correlation between exposure and efficacy. Our best efficacy is at 25 mg, where it's the best placebo-adjusted efficacy in FOS that we've seen in a clinical study.
We've got really good efficacy down at 10 mg, and we also have the AE profile, which changes as you increase dose as well. You see more CNS-related adverse events at 25 mg. You see much lower rates and very comparable to what we saw in the placebo arm in the phase IIb study at 10 mg. Our goal is to get all four of those doses on label. We think that that's going to provide a lot of optionality for clinicians to try and find the right dose for the right patient. We do know there's a BMI to exposure relationship, so if you're a really slight patient, you probably don't need to be on 25 mg of azetukalner. You can probably get good efficacy and moderate any of the side effects at a lower dose.
For patients who've got really difficult-to-treat seizures, or maybe are heavier, then maybe 25 mg is good. In practice, I think what we hear is that a lot of physicians may start at 15 mg. In fact, that's one of the things that Dr. French commented on at the EEC conference, is that in her experience, she probably will start patients at 15 mg and then move them up as needed, versus starting them at 25 mg and bringing them back down. For us, commercially, it won't make a difference. We're looking to do flat pricing. I think this gives the physicians a lot of choice as far as how they manage their patients without an economic impact on us. We've got good, strong data across those two studies to show that we've got good support for each of those doses.
That's great. Actually, you mentioned pricing. What have you said about pricing? I think a lot of us have sort of the context of XCOPRI, that those priced a number of years ago. I guess, what are sort of the guardrails in terms of the pricing that we should be thinking about?
The epilepsy market's really interesting. On the one hand, it's got a lot of drugs available to it. There's 20+ medications that are approved for epilepsy. They tend to cluster in a couple different mechanisms, as we talked about, SV2A, sodium channel blockers, but there are a lot out there. Right now, there's really only one branded drug left. That is XCOPRI or cenobamate, marketed by SK Life Science. The prior generic, BRIVIACT, just went off patent from UCB earlier this year. It's an interesting market in the sense that a lot of it's generic with very few brandeds. The branded that is out there now is priced at about $15,400, roughly. That's gross a year. BRIVIACT, before it went off patent, was around $18,000.
But as you said, Ben, cenobamate was approved back in 2019, so it's been a while, and drug pricing in the U.S. in general has really shifted upward in the last few years. We think that there is an opportunity that even cenobamate could've priced higher at the time. As we think about the pricing decision for azetukalner, we think we've got, one, a great drug that's got a really strong clinical benefit, from efficacy to the ease of use. It's got a mechanism that doesn't have any other peers out there in epilepsy today, so the only potassium channel modulator. We think we've got good value. So we'll be looking to try and price at a premium to where the branded drugs are and were, so something north of that $15,000 or $18,000. Beyond that, we haven't provided any more specificity.
The team's doing a lot of work now to understand better what sort of reactions there might be from the payer community. The other good thing is that there's a real alignment, we think, today with how payers look at it and what clinical practice is like. So we think at the outset we'll certainly be adding on to existing ASMs that patients are already taking. We're not going to be the first drug somebody gets when they're diagnosed with epilepsy. In practice, patients will have probably already been on a monotherapy probably twice. Usually, they start with either an SV2A or a sodium channel blocker, and then if their seizures aren't well controlled, they'll kind of flip and go to monotherapy to the other.
So oftentimes, by the time they get to that first add-on, where we hope to eventually be, they'll have already seen a couple generics. So from a payer standpoint, the step-through of generics will likely already be happening in practice. In addition, because it's not a heavily managed class, it doesn't have a lot of branded drugs today, it's not getting a ton of attention or costing the sector a lot, and it's a protected class for government pay purposes. So we think there are a lot of things that will help give us good momentum going into that pricing decision next year. Starting with, we've got a great drug that we think is going to help a lot of patients and has a novel mechanism and great data.
That's great, and I appreciate the color on the practice dynamics. Given the current status of epilepsy care, what's your launch strategy, and who are your initial call points when you're approved?
Yeah. At the outset, we do think that patients that are really not well controlled under their existing ASMs, who are typically seen by epileptologists, will likely be the quickest early adopters. So those are patients that are probably not too dissimilar from what our study population looked like. They have probably tried five or six anti-seizure medications. They are on two or three, and they are still not effectively controlled. We think those are rapid adopter patients. But ultimately, we think this could be a really big drug, and we think it could be used much more broadly in FOS. We are going to be targeting not only those patients, but again, trying to move earlier in the treatment paradigm, not up to initial diagnosis, but maybe that first add-on timeframe, where we think it could be really impactful for patients.
From a call point perspective, that means that at the outset, it is going to be more concentrated among the epileptologists. Not surprisingly, they see a higher rate on a per capita basis than the general neurologists do. But general neurologists and primary care and APPs also prescribe a lot of ASMs. There are some that are more epileptologist-like. They have got a higher concentration, higher frequency of epilepsy patients, so we will certainly be targeting them at the outset. Our total universe will be around 7,000- 8,000 physicians. Of those, there is about 1,500 epileptologists in the U.S. The balance are our key targeted general neurologists. We use things like non-personal promotion to go after the broader general neurology community at the outset. But our goal is not to just be a drug that is used amongst the epileptologists.
We think it is one that has got good uptake and utilization more broadly. If you look at analogs in terms of drugs that have been more relegated to the epileptologist, that is things like XCOPRI. It is a very good drug. It is very effective, but it is a little challenging from an ease-of-use standpoint. It has to be titrated over many weeks. It has drug-drug interactions that require you to down titrate or up titrate other drugs once you put them on cenobamate. They tend to be used really by the epileptologist and not by the general neurologist. They are doing well. They are probably annualizing about $600 million in the U.S. today. On track, the company is guiding $2 billion at peak. But then you look at drugs like VIMPAT, and before that went off patent in 2021, they were doing about $1.3 billion in the U.S.
They were much more widely used, even though their efficacy was not as good as what we see with azetukalner or even what cenobamate has, but it was very easy to use. It had a lot of ease-of-use attributes. In today's dollars, if you put a premium price on that, it is a multi-billion dollar drug. I think for us, pricing is important, but it is really about getting that breadth of access to the epileptologist, as well as to the general neurologist, too.
That's fantastic. And so I guess expanding on that is, as you kind of mature in this launch and go out to the general neurologist, what are kind of the sales force investments that you think you would have to make over time?
Yeah. So it's nice. The U.S., we think we can address it with a sales force of maybe 75+ reps, 150 total for our commercial group, as well as obviously we'll have MSLs. We've made really good early investments in our MSL community over the last couple of years. So we have a team now of 8- 10 MSLs that cover key opinion leaders, help with awareness of the medical need, and that will serve us well for scientific communication once we launch as well. But it's a nice focused market that allows us to really get access to those epileptologists that are higher prescribers, focus on those general neurologists that do see a lot of epilepsy patients, and concentrate on ones where we can really get that mind share, that those physicians will be the ones that their peers look to.
So, this tends to be a slightly more conservative physician base. So they'll often want to see and try the drug in their hands with their patients. But once they get a handful of patients that have had good experience, I think they'll become much more likely to use themselves and also be people who can help reflect that back out to the broader community. So we think a kind of targeted field force here in the U.S. can be really effective, and allow us to get the kind of breadth and depth of penetration that we want. And if we need and want to flex more, and add more reps or do some things creatively, we think that's going to be really important as well.
And just one last question on this. So, we have a lot of examples within epilepsy in terms of commercial launches to kind of look at, kind of guide expectations. You talked about some pretty interesting sort of peak sales numbers, but how long would it take to get there? Is this kind of a slow build, or would this be more of a hockey stick kind of launch curve?
Epilepsy launches tend to be, as they say, low and slow. We would expect that our goal with the data that we have and the drug that we have is try and outperform what we've seen historically, but it's not going to be a hockey stick, right? This is not a rare disease or target oncology, the world I came from before, where you've got patients that are really desperate for therapies, and you get these kind of quick adoptions and then kind of plateauing. You typically, on the plus side, tend to see that ASMs grow into LOE, into a loss of [IP expiring]. That's good. They continue to kind of grow over time, but they're not hockey sticks at the outset.
We look at the analogs in the past, and we think, again, given the profile that we've got, our goal is to take some of the historical launches, and try and bend that curve upward. So, try and do better than others have, and again, we think we've got the attributes to do it with the drug, and we're going to work on other things, too. One of the other components the commercial team is working on is our channel and our distribution method. Historically, ASMs have gone through the retail channel, which in general, across pharmaceuticals in the U.S., have been more difficult in the last few years, but particularly in epilepsy, what we see in the data, is that it's incredibly difficult for patients to get access, to have stocking. Even with things like cenobamate, we see a high abandonment rate.
The physician writes a script, but the patient goes to the pharmacy, and for whatever reason, it's not in stock. There's a prior auth. There are other barriers that prevent that script from being filled, and that's a shame, right? The physician, the patient have both decided this is a drug the person should try, and the logistics of the channel and the market access shouldn't be the thing that stands in the way. Our team that's come from places before where they've done both retail but also specialty pharma models, launching products like EPIDIOLEX at GW and then Jazz, are going to be looking to put in place a specialty pharma model. We think that's going to help across a variety of fronts.
One is it's going to help with things like uptake and compliance, so those refills or those new scripts are actually filled, and you don't have abandonment at the pharmacy door. It's going to help facilitate it for physicians and patients to be able to navigate through, whether it's a prior auth or other insurance impediments that they need to do. That's particularly important amongst general neurologists, right? They're seeing a lot of different types of patients, a lot of different medications. They're not loving drugs that take a while to titrate or have DDIs, and they also don't love drugs where they're going to have to spend a lot of time working to try and make sure they've got coverage and access for the patient. We think kind of a more white glove service will be really helpful there.
In addition, it's going to give us a lot of data. With a specialty pharma model, it allows the manufacturer to have better understanding of the patient journey and the narrative, to assist the patient as they move through that process, and understand better what it looks like in terms of refills or other medications they're on. There's a lot of advantage to us from a patient standpoint and access standpoint, and I think all those things together we think is a really compelling profile of the drug. Will hopefully allow us to build a launch curve that looks better than we've done in the past, with we think are some really good potentials at peak, but it will be a slower ramp than maybe in other indications investors are used to seeing in other areas.
Okay. That's fantastic. I guess, as we think about label expansions and additional opportunities, how important is the pediatric and adolescent population from a commercial perspective?
Yeah. There are other opportunities within epilepsy that we're working on. One is primary generalized tonic-clonic seizures, which used to be called grand mal seizures. These are not focal, meaning they don't start in one part of the brain, but they happen across both lobes of the brain. Those are difficult studies to enroll, but really important to your point of building the sense that this is a general epilepsy drug. That comes through label expansions for things like PGTCS. So we're running that study. Takes a while, so we don't have any guidance yet as to when we'll do it. And things like pediatric indications, right? Epilepsy tends to be bimodal in terms of when patients are diagnosed, oftentimes in childhood or teenage years, and then more after that, later in life.
There is a strong pediatric need for other epilepsy indications beyond some of the rare developmental epilepsies. We'll have commitments and be doing pediatric work with additional formulations over time. But it will be important over time to have some of those additional data points to have a broader, both expanded label and a broader perception amongst physicians that azetukalner can be a broad anti-seizure medication that they can use for their patients in focal onset seizures, PGTCS, or in pediatric areas as well.
Great. Just with regards to X-TOLE3, this next study that is in the works. Given the geographical differences, would you expect any notable differences in the patient population under study versus X-TOLE2?
Yeah. The studies are very similar in terms of enrollment criteria, in terms of what we are looking to do for endpoints. There is obviously always variability from trial to trial. We would certainly expect some. We do have a slightly different mix of sites, both U.S., European, and also now we can touch on the fact that we have made a change in conjunction with our discussions with the regulators in Japan to use part of that study to add some Japanese subjects. We had originally X-TOLE, which is a phase IIb study, eight-week trial. Then we have X-TOLE2, which is the data we read out earlier this year, phase III study at 12 weeks. Those are going to form the basis of our NDA submission here in the U.S. X-TOLE3 is a study that we designed originally to have global regulatory reach.
The European regulators have guidance that they like two 12-week studies, and I mentioned X-TOLE originally, the first study, the phase IIb was an eight-week study. To be compliant with that, we would have needed technically two. I think with the strength of the data we have from X-TOLE2, we may have a compelling package, but nonetheless, we are well on our way with X-TOLE3, with a second 12-week study for EMA purposes. What we said earlier this year is that of those 360 patients in X-TOLE3, we had aligned with the regulators in Japan that we could utilize 60 of those patients for Japanese subjects. That combined with an ethno-bridging study would be sufficient for an efficacy study for Japanese approval and submission.
We said that we would have about 300 of those patients outside of Japan, and that those we would expect to have enrollment completed around the end of this year. No guidance yet on full enrollment, including the 60 extra subjects in Japan, and when we would read that out. We will read that study out all at once with both the non-Japanese and the Japanese subjects. Again, gives what we think is a really strong package for a partner. We are not intending to commercialize outside of the U.S. ourselves. For either a regional or global partner, we have got a dossier that we think is really compelling for Europe, for Asia as well, and a regulatory submission package that is really robust for all jurisdictions.
Okay. That's fantastic. I want to move to depression now. You have your X-NOVA2 trial, which is ongoing. I guess the question is what do you see the role of this mechanism in depression and what placebo drug difference would you find clinically meaningful and commercially impactful?
Yeah. There's still a really high unmet medical need in MDD. Despite psychedelics coming on and doing really well for patients with treatment-resistant depression, we still think there's a strong unmet medical need. We've seen data from our studies in the past and other Kv7s that Kv7 modulation can have an antidepressant effect. From a clinical study standpoint, what I think clinicians would tell you is that depending on the endpoint, a MADRS or HAM-D17, we're using the HAM-D17 as the primary in our phase III study, that a separation of about 2 points is clinically meaningful. What the market research will tell you is that given the desire for multiple modalities, new mechanisms, and the challenging AE profiles that a lot of the current MDD drugs have, sexual dysfunction, weight gain, that a differentiated profile is something that prescribing decisions are made on the back of.
There's the what's the clinically meaningful bar that's in that 2-point separation from placebo range, and then there's what will ultimately be commercially meaningful, and that's a more holistic view of the efficacy, but also what AE profile and mechanism do new agents bring?
That's great. Actually, going back to your epilepsy study, I think you had some patients with comorbid depression. I believe depression was sort of captured in a patient-reported outcome, the Beck Depression Inventory Scale. There it is. I guess, yeah, can you talk about that, and were there any patients in that study that had active depressive episodes that you were able to look at the effects of azetukalner in?
Yeah. A lot of patients, unfortunately, with epilepsy suffer from depression and anxiety. There's a high rate of comorbidity between those sort of neuropsychiatric conditions as well as epilepsy. But we didn't, one, enroll or enrich the trial for patients with epilepsy, and we didn't do the same level of screening and assessment that we would do in an MDD study in epilepsy. As you said, Ben, we did do patient reported outcomes and looked at patient reported symptomology, but we didn't do the more clinical workup that you would do with a psychiatrist that you do in an MDD study. We've got limited insights into it. It wasn't intended to look at an enriched patient population, and we weren't looking at outcomes.
What we saw is that in the epilepsy study, patients on both the active arms and the placebo arm did a little bit better on their self-reported outcomes. That's not surprising in some ways, in the sense that what we also know in general in clinical studies, that patients that are being seen more often and going to clinics, if they do have ongoing depression, that that can help a bit with some of their symptoms, and they can have some relief of that from there. We got a little bit of insight from that, but not a significant read-through to the MDD studies. But what we also know is that for physicians, there are some ASMs where it's not only mood neutral or mood positive, but mood negative. There are some irritability, aggression that can be seen with other anti-seizure medications.
I think being able to come out of the studies and see mood neutrality, not having that sort of irritability, aggression as a symptomology is something that was well received as well.
Okay. That's fantastic. In the last couple of minutes, let's talk about the pain program. I guess question number one is why advance a second Nav1.7?
Yeah. A Nav1.7 is a really compelling target. It's something that we at Xenon have worked on for a long time. As a company, back in its founding days, we were a genetics company, and we cloned the gene. We know Nav1.7 really well. We then entered into partnerships with a variety of pharma companies in mid-2010s to develop chemistry against it. These are patients who, despite having no other real symptoms, feel no pain. It's been a really compelling genetic story. For us, it's all about getting the right chemistry and finding the right profile. The drug that we are first in the clinic with now called XEN1701, we think solves a lot of the challenges that we and others have experienced in terms of putting together the right chemistry against this target over time.
One of the things that historically had been a problem is these are drugs that really didn't have selectivity. They were hitting the other sodium channel isoforms. Those non-selective compounds were not effective at showing efficacy, and they had side effects and tolerability profiles. We think we've got a Nav1.7 in XEN1701 that's really selective. It also needs to be something that has got good pharmaceutical properties, so good free fraction. There was a drug from Pfizer that was good and effective. It even showed a little bit of efficacy, but it had a very high protein binding rate. The free fraction rate was not what it needed to be to get drug exposure. Our current asset has that, and we think you need to be in the central nervous system.
XEN1701, we think, is the drug that is going to allow us to test in a proof of concept study, starting sometime next year, in acute pain, whether or not we can replicate the human genetics and have an analgesic effect without an opioid based on targeting Nav1.7. We think it's a really compelling target, and we think that there's a lot of opportunity in both acute and in chronic pain. For us, using our expertise in ion channel drug development and our expertise, in particular, in Nav1.7, having multiple shots on goal is really important. We announced at our Q2 earnings call that we had brought a second Nav1.7 inhibitor into the clinic that's following on from XEN1701. We'll continue to progress both of those through.
We'll provide an update on XEN1701 a bit later this year that we've given a lot of, I think, color on how well the program's been going so far this year in terms of being able to hit what we think the right receptor occupancy is. The emerging AE profile looks beneficial for what we want to do in the POC. We think we'll be able to move that forward pending the final results. Then we'll have a follow-on with the next- generation Nav1.7 that will give us some optionality as we learn more, moving into the patient studies in acute pain and give us more options to develop more chemistry. It's similar to what Vertex did. They're the leader in targeting sodium channels for pain. They've got JOURNAVX or suzetrigine, which is a Nav1.8 inhibitor. But they didn't stop at just that.
They've brought forward and continue to bring forward more Nav1.8 inhibitors. Other companies, like Latigo, in the Nav1.8 space also, again, have different Nav1.8 inhibitors that may serve different purposes and have different properties. We think it's a great investment to make and a really important target.
Those drugs you just mentioned, JOURNAVX, Latigo, the commercial opportunities that we're seeing, is that a good proxy for how you're thinking about the commercial opportunity in acute pain? I guess, how big could a chronic pain opportunity be?
Yeah. Certainly when you think about a chronic non-opioid analgesic is potentially huge, right? There's a variety of very large market indications with long duration of therapy that could make for a very large commercial market, which is why it's been so attractive to try and find options outside of opioids that don't have the addictive properties. We think that drugs like Nav1.7 have that possibility, and chronic pain is certainly a market that I think everybody believes for Nav1.7 or Nav1.8 could be really big. We'll certainly look to try and progress there. For a quicker proof of concept, acute pain has been the path that's been more well-worn. That's both by Vertex and by companies like Latigo. Vertex now, the last couple of years, has been out in the market. They got JOURNAVX approved.
It's an effective drug that doesn't have the liabilities of opioids, and the acute pain market is challenging, too, right? You've got opioids which are very effective, easy to use. Hospitals and doctors have been using them for a long time, and they're relatively cheap. Vertex has made a big investment, and they've done a really good job of building that market. We're kind of happy to have a company with the commercial chops of Vertex out there doing that hard work. They've guided to tripling the number of scripts this year, and based on the data so far, looks like they're doing just that, well, if not better. It's a matter of can they convert some of these free drug patients or lower cost commercial patients and others to more pain drugs.
We think they're doing really good work to try and transition this market from being focused solely on opioids, really, to kind of broadening that. That may play out well for those of us like Latigo and Xenon coming behind, and making the acute market even better. We'll see. For us, the acute market right now is really about getting that proof of concept. The studies you run there, these abdominoplasty and bunionectomy studies can be run relatively quickly, and allows you to get good read, whether the RO profile that we've identified here that we think is going to be compelling is really going to help replicate those human genetics and have an analgesic effect.
Absolutely, we think chronic market is where the large market opportunity is, and so we'll continue to do the work and find the time as we progress the clinical program to move toward that as well.
Just last question on this. Have you articulated, or has Xenon articulated yet the strategy in terms of moving into that chronic market? Would you just fully develop and de-risk the drugs in the acute market first or the acute setting and then consider chronic? Do you think you might parallel that?
I think that is still an open question. I think what we do know is we are going to move into acute first in terms of getting that POC. This is both with our Nav1.7, but we also have a Kv7, same mechanism as azetukalner for pain. Both of those will go in an acute study first. We will look to figure out whether we go full on and move toward a registration package in acute. That would require an additional larger study and then typically what you see with others is that you do kind of a broad-based pain program coming out of a variety of surgical indications. Or whether we, as you say, kind of parallel process and move more rapidly toward the chronic market. We will have some additional data points. There will be additional, both acute and chronic from the Nav1.8 competitors out there.
They are not obviously perfectly analogous, but they will be good read-throughs. There is a variety of different indications you can do in chronic. We have seen DPN, we have seen osteoarthritis, dental pain. I think we will continue to learn from those who are a little bit further ahead of us in terms of what they see in the chronic market from a clinical development standpoint. That will help, I think, inform us in terms of how do we sequence our investments on acute versus chronic, and what is the right timing of those.
Okay. Well, fantastic. Just any questions from the audience? Okay. Tucker, thank you.
Thanks for hosting. Take care.