Vimal Mehta, CEO, and Vince O'Neill, Executive Vice President, Chief of Product Development and Medical Officer, BioXcel Therapeutics.
Thank you. I like to start by thanking Jefferies for giving us the opportunity to present at this conference. Good afternoon, everyone, and thank you for joining us today. I'm very pleased to share the exciting developments in terms of market expansion for our lead product, BXCL501, with you, and now we are gearing up for two pivotal Phase 3 trials. Just to remind everyone that I will be making some forward-looking statements. We are building a leadership position in the acute treatment of agitation, and with our two advanced programs, SERENITY and TRANQUILITY, we believe that we can achieve that. So I'm going to discuss at length where we are with these two trial designs in terms of readiness to initiate the trial and when the data readouts can happen.
We believe these two late-stage programs set up a path for us for potential two sNDAs . As you all know, we have an IGALMI drug already approved, and this will allow us to expand our market opportunity. In addition to that, we continue to maintain our market presence for IGALMI. It is helping us build the brand equity. It's strategic, as well as it building the physician and caregiver experience by the time we start the journey for moving the 501 into the home setting in schizophrenia, bipolar, and into in-care and home setting into Alzheimer's-related agitation. The current market opportunity for IGALMI captures about 16 million episodes. These patients show up in the emergency rooms, in psych units, or in care units, wherever the doctors are, and IGALMI, they can be treated with the IGALMI.
Our strategy was always learn and expand, and by expansion, we can capture additional 23 million episodes in bipolar and schizophrenia agitation, where these patients are residing in the home setting, and they have literally no treatment options currently. There are no FDA-approved drugs for treatment in a home setting. The second opportunity, which is Alzheimer's agitation, is really large. It's approximately 100 million agitation episode. So we are in the market with 16 million episode that we are marketing IGALMI with our small footprint, and then we have an opportunity to expand this now into an additional 123 million episodes, approximately. So the total opportunity can be really large, once we are successful with the clinical trials, 2 pivotal clinical trials and filing of our sNDAs. Let me now discuss our first SERENITY program, which is related to schizophrenia and bipolar agitation.
It's a very near-term opportunity. This could allow us to expand the label for our currently approved drug, IGALMI. Agitation is a very debilitating condition for patients, as well as threatening to healthcare providers. There are no current treatment options. Our current approved drug, IGALMI, is already helping patients and healthcare providers, and we're getting very positive feedback from the physicians, and we are highly motivated now to expand this treatment option to broader patient population that lives in the home setting. We had, two meetings with the FDA related to this program in last six months, and our goal was to develop a clear game plan that what is the next trial we need to do, what would it take to file a potential sNDA, and by when we can get to the market, with this indication.
So we are very pleased to have a clear development path for bringing this drug to the home setting. SERENITY I and II, that you see on the left, resulted in approval of IGALMI. Those were two pivotal trials that we conducted in schizophrenia, bipolar patient. Now, we have a clear game plan to initiate a SERENITY At-Home trial, and we have a clarity with the FDA what we need to do for this trial, and we have agreed on the key trial design elements. Once we have completed the trial, trial is successful, it will lay the path for a potential sNDA in the home setting. The SERENITY At-Home trial is evaluating 120 microgram dose. That is the lowest approved dose of IGALMI, our current, marketed drug, and the primary endpoint for this trial is safety.
We have already demonstrated efficacy in two well-controlled trials in SERENITY One and Two, so the primary goal here is safety, and based on our extensive experience in conducting these trials, these trials are efficient in terms of time as well as capital requirement. So we are looking forward to initiating these trials. We have the technical readiness in terms of protocols have been submitted to the FDA. We have a CRO in place, and we are doing the site selection so that we can initiate these trials. If you look at this graph, and we did the market research to understand how patient will use this if this drug is approved in a home setting, and our market research is very supportive of expansion into the home setting for treatment of agitation in this patient population.
When a profile of BXCL501 was shown to the patient, there was a very strong response by 80% of the patient that... or agitation episodes in the home setting can be treated with 501. There are some other medications are used, but none of the medication, I want to make clear, for schizophrenia, bipolar agitation, is approved by the FDA for the home setting. As you all know, IGALMI was approved a couple of years back. We have launched the drug. It's already helping thousands of patients and caregivers. We feel very passionate and motivated that this is... Feedback we get from both from the patients and we get from the healthcare providers is very encouraging.
When a patient comes in an ER room or in a setting where they're very highly agitated, some of these patients get completely calm within a half an hour to two-hour period, and they can be discharged from the hospital setting. Some of these patients, as you know, come in a four-point restraint when they are brought into this setting. IGALMI has two doses approved, 120 microgram and 180, and both doses we are finding are being used in the real-life condition, and the feedback has been extremely positive. That lays a nice foundation for our new indication that we are trying to expand into with our pivotal trials. We have a very small footprint of market access team of about six people that is deploying a volume contracting strategy.
And we have seen some uptick in our revenues, and that's primarily driven by volume contracting that we have adopted our existing customers, repeat users. We are acquiring some new customers, and also we are expanding into new channels. So it's a very focused strategy to continue, and the value of doing this is it helps us maintain our brand, as well as develop the physician and patient experience. And it's very capital efficient in terms of the way we have now designed our commercial strategy to maintain our brand in the marketplace. I'd just like to point out that both settings, whether institutional or home setting, they are very complementary to each other. The patient journey starts for agitation in a home setting, and then when a agitation is a spectrum, it can be mild, moderate or severe, and when it escalates and patient cannot...
They know they're going to either get in trouble, they end up in the ER, or they are brought in by other people into that setting. So if there is a drug that can treat their agitation in a home setting, that could be a game changer for these patients because they can take that drug in the early stages of their agitation before it reaches to a level when they don't have control, and they are brought into those institutional settings. We believe that treatment options are needed in both settings. For institutional settings, we have 120 microgram and 180 microgram doses approved, and depending on the nature of the patient, physicians use either 120 or 180, how fast they want them to calm down.
And we believe that the treatment, both treatment options in an institutional setting as well as in home setting, are needed. So Serenity program is a near-term value driver for the company. We have approval in the institutional setting, and we have set up with Serenity at Home trial to expand, potentially expand our label into the home setting. Let me now discuss the Tranquility program, which is for acute treatment of agitation associated with Alzheimer's dementia. It's a very large opportunity. It's a long-term growth opportunity and a very in a highly untapped market. There are no drugs for acute treatment of agitation that have been approved in a home setting. We believe for acute treatment, we have the leadership position, since we already have one positive Phase 3 trial in the Alzheimer's agitation.
Most of the patients, Alzheimer's patients, don't go to the higher level of care because of their underlying disease, Alzheimer's. They end up in those care because of the agitation that cannot be managed by their loved ones when they are in the home setting. So there is a huge healthcare burden due to the agitation, and I truly believe anybody who is successful in developing a drug will really make a societal impact, because this is a huge problem both for the patients, for the healthcare providers, and the family members. There are no current, as I mentioned, FDA-approved treatment options, and we are extremely passionate about bringing a new treatment option to these much-needed patients and caregivers, who really need some sort of a treatment, as and when these agitation episodes happen.
And as I mentioned, there are about 100 million episodes that happen in this patient population. Let me now give you the, what the overall program for TRANQUILITY looks like. We conducted a trial, TRANQUILITY I, and based on that data, we got a breakthrough therapy designation. Then we initiated a TRANQUILITY II trial that was announced. It's a Phase 3 trial, efficacy, safety, and continued efficacy over a three-month period. We announced the positive data there, and now we are, have a alignment with the FDA after having 2 meetings in a very short amount of time, that what the next steps will be. So next step or next trial in this will be another second efficacy trial.
It's very similar to TRANQUILITY II in terms of both primary endpoint, which is reduction in PEC at two hours, and that's the primary endpoint, and overall design is very similar to TRANQUILITY II. So let me just give a little bit overview with what medical settings these Alzheimer's patient live in. So once their Alzheimer is mild to moderate, they live in a home setting, and when they have agitation episodes, and they are not too frequent and not too many of them, they continue to live in the home setting as long as it's manageable situation. Once it start becoming unmanageable, they go to a little higher care of center, what is called an assisted living facility, and from there on, journey, because Alzheimer's is a very progressive disease, so they continue to escalate in terms of their number of agitation episode.
They end up in memory care centers, or if they need more help, into skilled nursing home. So that's the intensity. Depending on the disease intensity, they live in different care setting. So you will notice and see that the way we have designed our strategy is to be able to capture both aspects of the patient in the TRANQUILITY In-Care setting, as well as in the home setting. The strategy we adopted for schizophrenia and bipolar, we are adopting the same strategy to get this drug to the broadest patient population. TRANQUILITY In-Care trial design, as I already mentioned, is very similar to TRANQUILITY II. This study will evaluate 60-microgram dose of 501 over a 12-week period, which is similar in many aspects to the TRANQUILITY II. The primary endpoint is efficacy, also similar to TRANQUILITY II.
In TRANQUILITY In-Care, we are simulating the real-life, so we will be enrolling patients that are mild, moderate, and severe Alzheimer's patients, and across the spectrum, whether they are mild, moderate, or severe agitation. So it will be the real-life simulation in the trial, and that will, if we have that inclusion, exclusion criteria, that will get reflected in our label. So that's part of the reason this TRANQUILITY In-Care trial is designed. It has 150 patients, 75 in each arm, 60 microgram, 75 patients in placebo arm. Placebo arm also has 75 patients. This is an initial design for TRANQUILITY At-Home.
This is based on our experience with the SERENITY At-Home, and we had some preliminary conversations with the FDA around it, what kind of a trial we will need to conduct if we want this label to be expanded into the home setting. So safety, we believe, will be the primary endpoint, like we have it in the SERENITY At-Home. Once we believe we have two adequately well-controlled trials in the Alzheimer's, TRANQUILITY II plus TRANQUILITY In-Care, then we will be able to move this drug in the home setting. None of this TRANQUILITY In-Care or home setting needs to be parallel or staggered. We can either do this trial in staggered fashion and get to the sNDA with TRANQUILITY In-Care and then expand into the home setting, or we can start both trials and submit the package for a broader label with the FDA.
Those are the things we will be deciding that what should be the optimal strategy to get to the submission of our sNDAs in Alzheimer's agitation. Let me wrap up with a few closing remarks. So as you can see, that we have two pivotal programs very well set. We have protocol submitted, site selections have happened. We are leveraging our extensive experience, clinical experience and expertise, and now we are focused on advancing the clinical program and also strengthening our balance sheet. So we believe that with these two trial initiation and data readout, we are well-positioned to drive stakeholder value by maximizing the full potential of BXCL501 and continue to build a leadership position in acute treatment of agitation. Let me spend a minute on our other interesting asset, which is BXCL701.
There was a late-breaking abstract presented at ASCO by our investigator in the pancreatic cancer. This is a very exciting development for the program. Initial 6 patient data was re-presented, and it was a safety experience, but they saw the efficacy signals in terms of reduction of markers as well as partial response. And there has been number of links on the slide that you can look at. There is a press release. There is a video which talks about what the data is and what the excitement is around BXCL701 when it's combined with Keytruda. And this trial is run. It's a com- is run by Georgetown University, and it's in collaboration with Merck.
Merck is providing the Keytruda. The we continue to be focused on partnering and monetization this asset. We do believe with either monetization, partnering, or sale, we can bring some non-dilutive capital to the company to continue on our mission of BXCL501 in schizophrenia, bipolar, and Alzheimer's disease. I want to thank you for your interest in BioXcel Therapeutics, and I would like to now open the presentation for any questions, and I'm joined by my colleague, Vince O'Neill, who is the head of product development. Any questions? Otherwise, we can wrap up the session. No questions? Thank you very much for joining us today.