Good morning, ladies and gentlemen, and welcome to Axsome Therapeutics' conference call. Currently, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. Instructions will follow at that time. As a reminder, today's conference call is being recorded. I would now like to turn the conference over to your host, Mr. Mark Jacobson, Senior Vice President of Operations at Axsome Therapeutics. Please go ahead.
Thank you, operator. Good morning, everyone, thank you for joining us on today's conference call to discuss the positive top-line results from the MOMENTUM phase III trial of AXS-07 in migraine patients with a history of inadequate response to prior acute treatments. A press release announcing that AXS-07 achieved the co-primary endpoints in the trial crossed the wire a short time ago and is available on our website at axsome.com. During today's call, we will be making certain forward-looking statements. These statements may include statements regarding, among other things, the efficacy, safety, and intended utilization of our investigational agents, our clinical and non-clinical plans, our plans to present or report additional data, the anticipated conduct and the source of future clinical trials, regulatory plans, future research and development, and possible intended use of cash and investments.
These forward-looking statements are based on current information, assumptions, and expectations that are subject to change and involve risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements. These and other risks are described in our periodic filings made with the Securities and Exchange Commission, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements, which are only made as of today's date, and the company disclaims any obligation to update such statements. Joining me on the call today from Axsome's management team are Dr. Herriot Tabuteau, Chief Executive Officer, Dr. Cedric O'Gorman, Senior Vice President of Clinical Development and Medical Affairs, Mr. Nick Pizzie, Chief Financial Officer, and Mr. David Marek, Chief Commercial Officer.
Herriot will start by providing an overview of today's announcement before turning the call over to Cedric, who will review in greater detail the top-line results of the MOMENTUM clinical trial. Following Cedric's presentation, we will open the line for Q&A. Following the Q&A, Herriot will provide some concluding remarks. I shall now turn the call over to Herriot.
Thank you, Mark. Good morning, everyone, and thank you for joining us today on the call. We are extremely pleased to announce that AXS-07, Axsome's novel oral multi-mechanistic investigational medicine for the acute treatment of migraine, met the two regulatory co-primary endpoints and significantly improved migraine pain and most bothersome symptom as compared to placebo in the MOMENTUM phase III trial. AXS-07 also met the key secondary endpoint, demonstrating statistically significant superiority to the active comparator, rizatriptan, on sustained freedom from migraine pain. These positive results are especially notable because the study was conducted in a population with difficult-to-treat migraine and incorporated the active comparator, rizatriptan, which is considered to be the fastest-acting oral triptan and one of the most efficacious oral medications currently available for the acute treatment of migraine. The MOMENTUM trial enrolled only patients with a history of inadequate response to prior acute migraine treatments.
The patients in this trial exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes. The positive results of the MOMENTUM trial, therefore, have potentially important implications for patient care. The positive results of the MOMENTUM trial are also significant for Axsome as they support the filing of an NDA for AXS-07 in the acute treatment of migraine. We now anticipate filing two NDAs in 2020, one for AXS-07 and one for AXS-05 in the treatment of MDD. MOMENTUM, which was conducted pursuant to an FDA Special Protocol Assessment, randomized patients to treatment with AXS-07, rizatriptan, MoSEIC meloxicam, or placebo.
AXS-07 met the two regulatory co-primary endpoints by demonstrating, with high statistical significance, two hours after dosing, a greater percentage of patients as compared to placebo achieving pain freedom with a P value of less than 0.001, and absence of most bothersome symptom with a P value of 0.002. Superiority of AXS-07 to its rizatriptan and MoSEIC meloxicam components was established as specified in the SPA by demonstrating a greater percentage of AXS-07 patients achieving sustained pain freedom from two to 24 hours after dosing, compared to rizatriptan with a P value of 0.038, and MoSEIC meloxicam with a P value of 0.001.
AXS-07 provided substantially greater and more sustained pain relief compared to rizatriptan over 24 and 48 hours after dosing, which was highly statistically significant with P values of 0.006 and 0.003. This efficacy benefit translated to functional improvement as well as a significant reduction in the use of rescue medication with AXS-07 compared to rizatriptan with a P value of less than 0.001. AXS-07 demonstrated superior outcomes to rizatriptan on multiple other secondary endpoints. Was safe and well-tolerated in this trial. The seriousness of migraine is underappreciated. The World Health Organization classifies severe migraine attacks as among the most disabling illnesses, comparable to dementia, quadriplegia, and active psychosis. Migraine damages family life, social life, and employment. A significant percentage of patients experience inadequate response to current treatments.
Suboptimal treatment has serious consequences, as large-scale studies show that in addition to debilitating pain, it can lead to increased progression from episodic to chronic migraine. There is an urgent need for new treatments that provide improved efficacy for this serious neurological disease. AXS-07 is a novel, oral, rapidly absorbed, multi-mechanistic investigational medicine for the acute treatment of migraine consisting of MoSEIC meloxicam and rizatriptan. AXS-07 is thought to act by inhibiting CGRP release, reversing CGRP-mediated vasodilation, and inhibiting neuroinflammation, pain signal transmission, and central sensitization. Axsome's MoSEIC technology significantly increases the speed of absorption of the meloxicam component after oral administration while maintaining a long plasma half-life. AXS-07 is covered by 21 issued US and international patents, providing protection out to 2036, and Axsome maintains worldwide rights. I would now like to turn the call over to Cedric, who will review the MOMENTUM top-line results in greater detail.
Thank you, Herriot. The MOMENTUM, or Maximizing Outcomes in Treating Acute Migraine study, was a phase III randomized double-blind, multicenter, active and placebo-controlled trial to assess the efficacy and safety of AXS-07 in the acute treatment of moderate and severe migraine in adults. The study was conducted pursuant to an FDA Special Protocol Assessment. Only migraine patients with a history of inadequate response to prior acute migraine treatments, as assessed by the Migraine Treatment Optimization Questionnaire, or mTOQ-4, were enrolled. A total of 1,594 subjects were randomized in a 2 to 2 to 2 to 1 ratio to receive a single dose of AXS-07, MoSEIC meloxicam, rizatriptan, or placebo following a qualifying migraine. The co-primary endpoints of the study were pain freedom at 2 hours and freedom from the patient's most bothersome migraine-associated symptom, nausea, photophobia, or phonophobia at 2 hours for AXS-07 as compared to placebo.
The key secondary endpoint to establish component contribution was sustained pain freedom from 2 to 24 hours after dosing for AXS-07 as compared to rizatriptan and MoSEIC meloxicam. Shown here are the key inclusion criteria. In addition to a history of inadequate response to prior acute migraine treatments, eligible patients were required to have an average of 2 to 8 moderate or severe migraine attacks per month. The characteristics of the patients enrolled reflect a population with very difficult-to-treat migraine, as shown on this slide. The mean mTOQ-4 score was 3.6 out of a maximum of eight, reflecting patients who are characterized as poor responders to prior acute migraine treatments.
In addition to a history of inadequate response, enrolled patients exhibited a high rate of characteristics that are strongly associated with poor treatment outcomes, including cutaneous allodynia, or pain from a normally non-painful stimulus, which was seen in 75% of patients, severe migraine pain intensity, which was seen in 41% of patients, obesity, seen in 44%, and morning migraine, seen in 37%. As noted here, a greater percentage of patients in the AXS-07 group had cutaneous allodynia and severe migraine pain as compared to the rizatriptan arm. There were no meaningful differences in other baseline demographics or clinical characteristics across the treatment groups. Importantly, approximately 40% of patients described prior triptan use.
On the first co-primary endpoint of pain freedom at two hours, a statistically significantly greater proportion of patients treated with AXS-07 were pain-free as compared to placebo, 19.9% versus 6.7% respectively, for a placebo-adjusted difference of 13.2% with a P value of less than 0.001. On the second co-primary endpoint of freedom from the patient's most bothersome migraine-associated symptom, photophobia, phonophobia, or nausea, a statistically significantly greater proportion of patients treated with AXS-07 were free of their most bothersome symptom at two hours as compared to placebo, 36.9% versus 24.4% respectively for a placebo-adjusted difference of 12.5% with a P value of 0.002.
On the key secondary endpoint of sustained pain freedom from 2-24 hours evaluated in order to establish component contribution, a statistically significantly greater proportion of patients treated with AXS-07 had sustained pain freedom as compared to rizatriptan and MoSEIC meloxicam. 16.1% for AXS-07 versus 11.2% for rizatriptan with a P value of 0.038 versus 8.8% with MoSEIC meloxicam with a P value of 0.001. AXS-07 was also statistically significant versus placebo on this measure with a P value of less than 0.001. AXS-07 provided substantial and rapid relief of migraine pain as shown on this slide. The percentage of patients achieving pain relief with AXS-07 was numerically greater than with rizatriptan at every time point measured starting at 15 minutes and statistically significant by 60 minutes. This performance over rizatriptan is significant since rizatriptan is widely recognized as the fastest acting and one of the most effective oral triptans.
This slide shows the pain freedom rates over time starting two hours after dosing. AXS-07 resulted in a consistently greater proportion of patients experiencing pain freedom compared to all comparators with the benefit provided by AXS-07 increasing over time. One of the key goals of acute migraine treatment is not only to rapidly relieve pain, but also to provide durable pain relief that is sustained over time. As is shown here, AXS-07 provided substantially greater and more sustained migraine pain relief compared to rizatriptan, MoSEIC meloxicam, and placebo. The percentage of patients experiencing sustained pain relief from two to 24 hours after dosing was 53.3% for AXS-07 versus 43.9% for rizatriptan, with a P value of 0.006, and versus 33.5% for placebo with a P value of less than 0.001. Importantly, 80% of the AXS-07 subjects who had achieved pain freedom at hour two maintained it through hour 24.
The benefit of AXS-07 on sustained pain freedom and sustained pain relief is even greater over 48 hours. For example, the proportion of patients experiencing sustained pain freedom with AXS-07 over 48 hours is nearly twice that with rizatriptan in this population with difficult-to-treat migraine. The efficacy benefits of AXS-07 translated into significantly less use of rescue medication with AXS-07 as compared to rizatriptan. Subjects treated with rizatriptan were almost twice as likely to need rescue medication as compared to those treated with AXS-07 within 24 hours of their migraine. With only 23% of AXS-07 treated patients requiring the use of rescue medication versus 35% of rizatriptan patients with a P value of less than 0.001 and 44% of placebo patients also with a P value of less than 0.001.
Overall, greater benefits of AXS-07 as compared to rizatriptan were observed on multiple efficacy endpoints in this population with difficult-to-treat migraine as shown on this slide. In addition to the statistically significant superiority of AXS-07 compared to rizatriptan on 2 to 24 hours sustained pain freedom and pain relief, and on 2 to 48-hour sustained pain freedom and pain relief. AXS-07 was also statistically significantly superior to rizatriptan on the Patient Global Impression of Change score with a P value of 0.022, headache pain relief at 1 hour with a P value of 0.04, and return to normal functioning at 24 hours with a P value of 0.027. AXS-07 was safe and well-tolerated in this study. The most commonly reported adverse events with AXS-07 were nausea, dizziness, and somnolence, none of which occurred at a rate greater than placebo or greater than 3%.
There was one serious adverse event of miscarriage that occurred in the AXS-07 arm, which was deemed non-treatment related. In summary, in the MOMENTUM study, treatment with AXS-07 resulted in rapid, sustained, substantial, and statistically significant efficacy as compared to placebo and rizatriptan in the acute treatment of migraine in patients with a history of inadequate response to prior treatments. The efficacy benefits of AXS-07 translated into significantly less use of rescue medication with AXS-07 as compared to rizatriptan and placebo. Finally, AXS-07 was safe and well-tolerated in the study. We would like to thank all the patients who volunteered to participate in the MOMENTUM study.
Their participation has allowed us to generate comparative data for AXS-07 against a well-established standard of care acute migraine treatment as we strive to bring a new multi-mechanistic therapeutic approach to patients who are disabled by migraine attacks and have been underserved by current therapies. We would also like to thank our principal investigators and all the clinical site staff who collaborated with Axsome in the execution of this important study. With that, I would like to hand the call back over to Herriot.
Thank you, Cedric. I would like to hand it back to the operator to open the line for questions.
If you'd like to ask a question at this time, please press star then the number one on your telephone keypad. If you would like to withdraw your question, press the pound key. Your first question comes from Charles Duncan with Cantor Fitzgerald.
Hey. Good morning, Herriot and team. Congrats on very nice results in this MOMENTUM study. Have a couple of questions for you. Cedric, you did a great job answering how you established that patients had inadequate response or history thereof. I guess I'm wondering, how did you establish that the patient was experiencing sufficiently moderate or severe migraine to warrant treatment?
Thanks, Charles. That basically was worked into the electronic device where the patient would respond in their electronic diary. Once the migraine came on, and at such time as it reached moderate or severe intensity, the information that they would input into the electronic device, which is par for the course for these kinds of studies. Once they put in that it was of moderate to severe intensity, it would identify the migraine as a qualifying migraine. At that point, they would be eligible to continue through the time points, inputting their information as to severity and so forth, related to their illness experience. The device would allow them to continue once their migraine was identified as moderate or severe.
Okay. Just two other clinical questions, and I'll hop back in the queue. One is on the ongoing INTERCEPT study, in which you're evaluating earlier treatment of migraine. Would you anticipate maybe some differences in terms of patient heterogeneity or even perhaps a decrease in the primary endpoint, I guess, differences due to greater impact on less severe symptom presentation by placebo? Would you anticipate actually the reverse, to see a greater divergence between the curves?
I think it's very important data to generate because what is really characteristic and unique, because it hasn't been done before with the MOMENTUM trial, has been to look at patients with difficult-to-treat migraine. What we wanted to do by designing the INTERCEPT study was to generate data which more reflected real-world practice, where patients are advised to take treatment on the immediate onset of their migraine pain and to look at those response rates, and of course, it's placebo-controlled. It remains to be seen what the data show, but we think that the data generated, rather than being in the more difficult-to-treat population, will reflect all comers, migraine pain, earliest onset, you treat it, and then you see how this treatment will compare to placebo.
Got it. Last question is regarding the long-term safety study that's ongoing. Can you, I know that it's really a different study, but in terms of the patients who went through the MOMENTUM study, what percentage of patients are enrolling in the long-term safety study? Just remind us in terms of the requirements for multiple dosing, what would you anticipate in terms of the dosing frequency hurdles in that study?
Well, of course, Charles, the difference is that this will be episodic chronic administration of the drug. Patients are eligible to roll over from MOMENTUM. Quantifying percentages or anything like that, it was premature to say that, but they're eligible to roll over into the extension study. Thereafter, they will treat their migraines as they occur. We capture a lot of different data here, but the most important thing is to demonstrate that out to one year, patients are tolerating the drug.
Okay. Very good. Thank you for taking the questions. Congrats on the results.
Your next question comes from Joon Lee with SunTrust.
Hi. Thanks for taking my question. Congrats on the positive data. I also have a question on INTERCEPT study. Is this a gating item for the NDA in second half of 2020? If so, when can we expect the top line? Other than timing of the medication, is there any other differences such as baseline for the demographics? Thank you.
Hi, Joon, this is Herriot. INTERCEPT is not gating for the NDA filing for AXS-07 in the acute treatment of migraine. We're on track to report results from the INTERCEPT trial in the first quarter of 2020. In terms of the differences between INTERCEPT and MOMENTUM, there is one major difference in terms of the demographics, which is that INTERCEPT will take all comers. So it's more of a frontline population as opposed to MOMENTUM, which enrolled patients with a history of inadequate response. Then, as Cedric also outlined, the goal of MOMENTUM is to have patients treat their migraine at the earliest sign of pain as opposed to the MOMENTUM trial, in which patients were required to wait until their migraine had reached either severe intensity or moderate intensity.
Good. I have one follow-up. Given really significant positive impact of combining the triptan with meloxicam, do you have any future pipeline plans for combining meloxicam with other drugs for additional pain indications in the future? Thank you.
Axsome has a pretty broad pipeline. We do have a pipeline of assets that are not CNS. These are non-core assets. One of them is actually AXS-06, which does combine meloxicam with another agent for another indication. Right now, to be clear, our focus is on our CNS pipeline. We're looking forward to filing the NDA with AXS-07 next year.
Thank you. Congrats.
Your next question comes from Ram Selvaraju with H.C. Wainwright.
Thanks very much for taking my questions. Congratulations on this very strong data. Again, just to clarify, I wanted to ask whether you have more detailed thoughts on the potential read-through for the INTERCEPT top-line data readout, given the current MOMENTUM data, what we should be taking away from the MOMENTUM data set as the most key perspective as we approach the INTERCEPT data readout. Secondly, wanted to ask about whether you have had discussions with the FDA regarding the safety labeling for AXS-07. If specifically there would be any contraindication for use in individuals who have multiple cardiovascular risk factors, or if that's not yet come up, or if you don't think that's likely to be a factor going forward at all. Also wanted to ask about the safety profile, specifically relative to the cardiovascular context that was seen in the MOMENTUM trial.
Lastly, wanted to know if you could comment on what we have seen so far with respect to the efficacy profiles of the anti-CGRP agents in migraine and how that compares specifically to AXS-07 in the treatment context, not the prevention context, and how you expect AXS-07 to potentially be deployed, assuming approval in the context of a competitive field that includes both the injectable and oral anti-CGRP agents. Thanks.
Thanks, Ram, for the multiple four questions. I'll answer some of these and then turn it over to my colleagues to provide color on some of these answers. With regards to read-through from MOMENTUM to INTERCEPT, what's nice about the MOMENTUM trial is we now have efficacy data with AXS-07, which shows that in a clinical trial that set a very high bar with a very difficult to treat patient population against one of the most efficacious migraine treatments as an active comparator, that we were able to show not only strong separation from placebo but also from the active comparator. That certainly bodes well for any subsequent trial that we might do looking at the efficacy of AXS-07. That's the read-through to INTERCEPT.
With regards to the safety labeling for AXS-07, we would fully expect that we would inherit the safety precautions that are in the labels for rizatriptan and also for meloxicam. Just as a reminder, in our MINDSET survey and also in other physician surveys, the percentage of patients who do have cardiovascular contraindications to migraine treatments was reported at somewhere between 10%-15%, so that's a minority of patients. With regards to the safety profile of AXS-07 in the trial as it relates to the cardiovascular context, the drug was incredibly well-tolerated, and as we mentioned, in fact, the most commonly reported adverse events were all lower than placebo. There were no cardiovascular adverse events in the AXS-07 arm in the study. As the efficacy profile of AXS-07 as it relates to anti-CGRPs, all anti-CGRPs.
First of all, we should note that our study enrolled a patient population which is different from that enrolled by other recent studies. Again, this is a patient population with a history of inadequate response, a very difficult to treat patient population. This is the first time that this patient population has been studied in a large efficacy trial like this. Whereas the data for the other agents that are out there, the other recent agents, all study a frontline setting. Having said that, the therapeutic gain, which we saw with AXS-07 compared to placebo, was on the order of 13 points, which is on the higher end. It's actually higher than what has been reported with many of the oral anti-CGRPs. Again, we would caution that you should not make cross-trial comparisons since we are studying a much more difficult-to-treat patient population.
With regards to the commercial aspects of AXS-07, and I'll turn that over to Dave.
Yeah. Thank you for the question. I think one of the things that we really look at in terms of where AXS-07 would be positioned is really understanding what's the unmet need in the marketplace. While there's been a fair amount of discussion on what are the most prominent unmet needs, clearly efficacy seems to be what's driving the greatest unmet need out there. That was confirmed in our MINDSET survey with just over 100 physicians who treat migraine in a survey we reported out last month, where 80% of physicians believe that efficacy is the greatest unmet need.
When you look at the data that we just generated in going head-to-head against what many would consider to be the most effective triptan available today, and having superiority data, which we think is distinct, then when we put that profile in front of physicians, we weren't tremendously surprised to see their willingness to prescribe AXS-07. In fact, in the survey, when we asked that question, 87% of physicians said that they would prescribe AXS-07 over emerging therapies, which included oral anti-CGRPs or the gepants. We feel very confident that we are solving the right problem out there in terms of efficacy. We feel like our data is distinct and showing superiority over current standard of care. The survey data that we have with physicians confirms a very high likelihood to prescribe over emerging therapies as well as current therapies.
Thank you.
Next question comes from Yatin Suneja with Guggenheim.
Hey, guys. This is Derek on for Yatin. Congratulations, thanks for taking the questions. We just have a couple. In order to file in by the second half of 2020, could you just kind of explain what the safety database is you need to generate, and how does that work in light of the as-needed dosing schedule? Do you guys have any plans to maybe expand the clinical program to include a prevention type study with AXS-07?
Thank you for the questions. With regards to the safety database, we do need to have safety data on 100 patients treated for one year and 300 patients treated for six months. I think total number of treated patients, that would be probably 1,000 or so. The way that it works with the dosing schedule is that patients in our open label safety extension are required to treat basically every migraine that they have. We collect all of that data. That open label safety extension trial has been ongoing since early July, so we're pretty happy there. With regards to studying AXS-07 in the prevention setting, that is a very interesting concept.
The reason for that is one of the rationales behind the MOMENTUM trial and enrolling the patient population that we enrolled is the data from large surveys showing that suboptimal acute treatment does lead to progression to chronic migraine. We will certainly be looking at that on a longitudinal basis in our ongoing long term studies to see on what the potential impact would be or will be on migraine frequency over time.
Great. That is very helpful. Thanks. Congrats again.
Thank you.
Next question comes from Matthew Kaplan with Ladenburg Thalmann. Please go ahead.
Hi, guys. Good morning, and congratulations on the positive results. Just wanted to dig in a little bit more in terms of how you're thinking about the commercial opportunity for AXS-07 and if you have plans to partner in the U.S. or partner outside of the U.S. and how you're going to approach the commercialization of 07.
Yeah. Hi, this is Dave. Good morning, Matt. Thank you for the question. I think we've said previously that our plans are to seek partnerships outside the U.S.
We have every intention of commercializing AXS-07 within the U.S., and we are building our commercial capabilities to ensure that we can maximize the opportunity. I think with the results we reported previously in the depression category, this gives us a tremendous opportunity to look for synergies across not only the patient base but the prescriber base. We're very excited about the potential to commercialize within the U.S. as Axsome and looking across the therapeutic areas to have not only a highly effective commercial effort but a highly efficient commercial effort as well.
Great. Thanks for taking the questions and congrats again on the positive results.
Thank you, Matt.
We have a question from Myles Minter with William Blair.
Hi, guys. Congrats on the data. Thanks for taking the questions. Just my first one is actually on the rates of nausea as most bothersome symptoms in this trial. Do you have those rates? How well was that symptom particularly treated at 24 and 48 hours? My second question is to do with patients who, at baseline, if they came in with medication overuse headache. You showed a reduction in rescue medication usage. I'm wondering whether or not KOLs are thinking about this class in addition to your meloxicam here as a solution to that very prevalent problem there. Also if this trial was actually a true single-dose AXS-07 trial or whether these patients could voluntarily take another dose at two hours. That's it for me. Thanks.
Yeah. Thanks for the question. Let me do the last piece first. It was a pure single-dose trial, so they could only take one dose of study medication, which is important when you think about other trials where you're allowed to take your drugs again. This was one dose and you're done. It speaks even more strongly to the efficacy benefits that we saw. Your question around overuse headache. We work very hard to make sure that the patients coming in had migraine pain as opposed to other types of headache, which would complicate the picture as you're trying to look at efficacy for migraine.
You raise a really good point because given that the population of patients in this study was so unique in terms of being difficult to treat, you can imagine that these patients had been, to speak colloquially, somewhat through the mill in terms of trying treatments and not getting any benefit. There is a tendency, therefore, to overuse medication coming in. I'm sure that the patient population had quite a degree of that historically, as well as all of those other characteristics which we pointed out are associated with poorer outcomes. Overall, you try to make sure that you have a pure migraine population that are experiencing migraines so you can look at the efficacy of your drug. Did I miss a part of you? In terms of nausea, these rates are very competitive and very low.
None of the adverse events occurred greater than the rate of placebo, or if they did, it was less than 3%. Nausea was very low. We capture it at any time point over the safety follow-up period. You ask the patient to describe their adverse events or report them. Very low, very competitively low rates compared to other studies. Also, you have to bear in mind that nausea is also a component of the disease under study. That comes into it as well. You have to factor that in. Again, very low rates. Tolerability does not appear to be an issue with the drug, so we're very pleased with the findings there.
Great. If I may just add one thing to Cedric's answer around medication-overuse headaches. That's one of the reasons why we found the reduction in the use of rescue medication so compelling. There was a large separation there from not just rizatriptan, but also from the other treatment arms. This should speak well to the potential to avoid or certainly reduce medication-overuse headaches.
Great. That's helpful. My question around nausea was more to do with what proportion of patients selected that as their most bothersome symptom coming into the trial, as opposed to photophobia, phonophobia, and how well that particular symptom was treated at through 24 and 48 hours.
Yeah. No, that's a great question. We just received the data, and we wanted to get it out as soon as possible. We're going to dive down into further detail on the photophobia, phonophobia, and nausea piece of the most bothersome symptom in subsequent analysis.
Okay, great. Cheers. Thanks for the questions, guys. Happy New Year.
At this time, I will turn the call over to the presenters.
Well, thank you all for attending today's call. We are very pleased with the MOMENTUM data readout, given its potential implications for the care of patients with migraine, which is a highly disabling neurological disease. We look forward to filing an NDA for AXS-07 in the acute treatment of migraine in the second half of 2020. As a reminder, as we discussed, AXS-07 is also currently being studied in the INTERCEPT trial, which is evaluating the early treatment of migraine. We are on track to report top-line results from that study in the first quarter of 2020. Earlier this month, we announced positive results from our phase III trial of AXS-05 in the treatment of MDD. That enables the filing of an NDA for AXS-05 next year. We therefore will now have the potential to file two NDAs next year, one for AXS-07 and one for AXS-05.
We also announced earlier this month positive phase II results from our AXS-12 product candidate in the treatment of narcolepsy. We anticipate launching phase III trials with AXS-12 next year. When you step back, this has been a very productive month for Axsome, and 2020 promises to be a year of continued clinical and regulatory momentum for us. We anticipate next year filing two NDAs, top-line results from our ongoing phase III trials of AXS-05 in TRD and in Alzheimer's disease agitation, top-line results from our ongoing INTERCEPT trial of AXS-07 in the early treatment of migraine, and also the initiation of new phase III trials with AXS-12 in the treatment of narcolepsy. We recently completed a financing, which provides us with a very strong balance sheet, and this allows us to effectively execute on these upcoming milestones.
I would like to thank the Axsome team for their hard work and dedication, which is allowing us to advance our CNS pipeline with the goal of providing new treatments for the millions of patients who have failed by current therapies. Thank you. We look forward to speaking with you in the coming year.
This concludes today's conference call. Thank you for participating. You may now disconnect.