Great. Welcome everyone. Good afternoon. My name is Jessica Fye. I'm a large cap biotech analyst at JPMorgan, we are continuing the conference today with Insmed. Good news, we don't have to switch rooms for Q&A this year, so we're all gonna stay here after the presentation, go straight into Q&A. If you wanna ask a question, there's two ways you can do it. You can raise your hand, somebody will bring you a mic, you can type your question into the portal, it'll shoot it to an iPad I'll have up there, and I can read your question that way. With that, let me turn it over to Insmed CEO, William Lewis.
Thank you, Jess.
Sorry. It's coming up on our screen.
One second for a technical adjustment. I'll give you a preview. I'm anxious to share what's going on with the company, but in a moment, I'm gonna have to put up our forward-looking slide, forward-looking statement slide. I will be making some forward-looking statements, and these should be considered in the context of our public filings. I would encourage you to review all of these very carefully. The secret ingredient to creating a self-sustaining biotechnology company is having adequate capital, commercial and development programs that are of sufficient scope and stage, and a unique culture that allows talented employees to do their best work. For Insmed, 2023 is the year you're gonna see all of this on display.
As you can see on Slide four, a snapshot of Insmed in the present shows a company with a $1 billion in cash to support 4 distinct development programs. We're coming off of a year where we leveraged our global commercial infrastructure, excuse me, producing 30% revenue growth for our lead commercial program. As we enter our 5th year of launch, we anticipate this growth will continue in 2023, and are estimating revenue will be in the range of $285 million-$300 million. Importantly, the greatest near-term value will be generated from the pipeline programs that are reaching maturity, and you will see more important clinical data throughout 2023 and 2024. We see ourselves building a flywheel of value creation, and that value creation begins now.
On Slide five, you can see at a quick glance, we've constructed a range of programs at different stages of maturity. A robust pipeline where the vast majority of expenditures, more than 80%, are focused on the first 3 pillars. These programs are either already commercial or the closest to becoming commercial. Our fourth pillar is our early-stage research. 2023 will demonstrate for the first time, it's no longer just early stage, we're gonna be moving some of these programs into the clinic starting in the first half of this year. Today, for the first time, we identify the specific range of therapeutic areas these technologies will target. Musculoskeletal, CNS, ocular, rheumatologic, as well as other manufacturing innovations and other technologies that will provide a platform upon which we will continue to build the future pipeline of Insmed for many years to come.
This is all gonna be fueled by the commercial success of the first three pillars I've mentioned. Let's turn to our first pillar, ARIKAYCE. This is well known to many of you as our first commercial product approved in the U.S., Europe, and Japan, where it has demonstrated an impressive commercial performance. It is a first in disease product, which has enjoyed the support of the medical community, and it is the only product strongly recommended for use in international treatment guidelines for MAC-NTM that is refractory. This year, we will release data from the first of 2 phase 3 clinical trials, specifically in the Q3 , which will inform our ability to move this program into frontline patients.
As you can see at the bottom of this page, the increase in addressable patients around the world that would be afforded to us should we achieve success in the frontline setting is quite significant. Multiple times the size of the current refractory market opportunity. Given that we have achieved with just the refractory market, it is easy to see the significance of this year's clinical data readout and the opportunity to reach so many more patients with what would be a first in disease treatment approved for the MAC-NTM condition. I wanna remind you that the clinical profile between refractory and frontline is related to time. How long the infection has been in the body. There's a strong likelihood that our therapy is gonna work just as well in frontline as in refractory patients in our view.
I also wanna draw attention to some data we provided in our press release on Friday for the first time, and that is the current discontinuation rate for the first of these phase 3 studies called the ARISE study. At approximately 15%, it is less than half the discontinuation rate of the refractory study. This is a very positive development, and as a result, we foresee a strong argument for physicians to treat patients with NTM earlier in their disease to enhance the probability of successful treatment. Refractory and potentially frontline MAC-NTM treated with ARIKAYCE is an encouraging base from which to build the rest of our company and an exciting growth opportunity in its own right. However, our second pillar is even more exciting. If we turn to Slide seven, you see brensocatib, which represents one of the most significant pulmonary development programs in the last decade.
Not only is it a first in mechanism approach for the treatment of bronchiectasis, like ARIKAYCE for NTM, it would be another first in disease approval should the phase 3 trial currently underway prove successful. Bronchiectasis has nothing approved to treat it. While NTM lung disease has patients totaling perhaps 200,000 globally, if you consider all forms of the disease, the bronchiectasis indication we're targeting totals more than 1 million addressable patients at launch, with several times that also potentially in need of treatment. Our phase 2 data using brensocatib to treat bronchiectasis was successful and published in the New England Journal of Medicine. Our phase 3 program, which we hope will replicate the phase 2 results, will read out in just over a year, in the Q2 of 2024.
This will be a landmark clinical trial and one of the more important developments in pulmonary medicine in more than a decade. We are pleased to announce today for the first time that the blended blinded event rate in the ongoing ASPEN study over the last 3 months is 1.12-1.15 events per patient per year. This is a very encouraging statistic as it matches what we saw in the Phase 2 WILLOW study. This gives us great comfort that the patients in this study are consistent in profile and behavior with those who we saw in the Phase 2 study that was successful. This is something we watch very carefully, and it remains an extremely encouraging data point. Insmed already has the global infrastructure to launch this drug because it is the same call point globally as for MAC-NTM.
The synergy here could not be more perfect. Work in pursuit of what we believe will be one of the more significant commercial launches in respiratory disease in recent years is already underway. Let's take a moment to look more closely at this mechanism of action, because it is this pathway that suggests that bronchiectasis, as large as it may be, is just the beginning of the opportunity for this drug and for Insmed. Slide eight shows that brensocatib is a DPP-I inhibitor. This means it has the potential to be active in a range of neutrophil-mediated diseases like eosinophilic-mediated diseases, which multibillion-dollar drugs like Dupixent and Fasenra target. Neutrophils play an essential role in mediating inflammation. DPP-I activates neutrophil serine proteases or NSPs. By inhibiting DPP-I, we are inactivating these NSPs.
Through this approach, the ability to prevent this inflammatory cascade upstream in the bone marrow before the neutrophil is released is accomplished. Because of the promise of this mechanism of action and our results from healthy volunteer, non-CF bronchiectasis, and now CF patient populations, as well as extensive preclinical models, we are already turning our attention to other indications where this drug may prove effective, including CRS without nasal polyps and cystic fibrosis. As we turn to the next slide, I am very excited today to share with you for the first time the clinical data from our phase 2 PK/PD study of brensocatib in cystic fibrosis patients. This included patients who are on Vertex CFTR modulators and those who are not.
The key takeaway from this study, which lasted about 1 month and dosed CF patients to placebo 10, 25, and for the first time 40 milligrams of brensocatib, is that we saw a clear dose-dependent inhibition of all NSPs across all doses. It just doesn't get any clearer than this. This chart tracks blood levels of NSPs and their reduction. You can see the 3 NSPs across the top of the chart, neutrophil elastase, cathepsin G, and proteinase 3, and the various doses of brensocatib along the left-hand side. This is exactly what we hope to see in this study. Given the magnitude of NSP reduction we can see here, we can further conclude that while we could have increased to a 65 milligram dose for CF patients, it will not be necessary to do so.
We can use these doses and importantly, leverage the existing clinical study work done for WILLOW and ASPEN to help inform the safety and efficacy of brensocatib for cystic fibrosis patients. Turning to Slide 10. Taking a different comparative look at these data, we see remarkable consistency of these results across three different clinical studies of brensocatib, which again gives us comfort in the predictability of the mechanism. Here across the top of this chart, we see a comparison of three studies, two done by Insmed and one that was done by AstraZeneca before we licensed the drug from them in 2016. Specifically, in this case, we are examining blood levels of the NSP neutrophil elastase at the different doses 10, 25, and 40 milligrams versus placebo. Once again, we see clear dose-dependent reductions in each of these studies that is remarkably consistent.
This gives us great confidence that what we see when this drug is utilized in the clinical setting is not a fluke or a one-off chance finding, but a clear mechanistically driven reduction in the target and consequent biological impact. Please take note that the NA in the lower right corner of this chart is because we did not test 40 milligrams in the WILLOW study. For those who were concerned about the dose-response curve in the WILLOW study, these data should prove and provide clear comfort that we are witnessing the mechanism of action operating in a dose-dependent manner, exactly as we had hoped. Now, if we turn to Slide 11, it's important when considering the profile of any drug candidate to remember that it's safety first, then efficacy.
Here we saw again, no new safety signals from the use of our drug, even at the higher dose of 40 milligrams. Please note that the 1 serious treatment emergent adverse event indicated was unrelated to our drug and in fact was a pulmonary exacerbation brought on by the removal of the CFTR, which resulted in rapid degradation of the CF patient's condition. Coupled with the ongoing promising safety seen in the WILLOW study, as reported in the New England Journal of Medicine and the ongoing data safety monitoring board meetings, 3 of which have occurred in the ASPEN study with no concerns related to the study, we are excited by the safety profile we have seen to date from brensocatib.
When it comes time for the regulatory agencies to consider the risk-reward profile of this drug in various therapeutic uses, its safety profile will be a real advantage for that assessment. Turning to the next slide, 12. Given the strong safety and efficacy and mechanistic proof of the compound to date, it's worth pondering where it might be used and what that would mean for patients, Insmed, and our shareholders. Here across the top of this chart, we have itemized the diseases we are targeting and the size of these addressable markets. The opportunity for brensocatib across these indications cannot be overstated. Please take note, 3 of these indications currently have nothing approved to treat them. Bronchiectasis, phase 3 for non-CF bronch is underway, and this slide shows the potential population for all bronchiectasis patients. CRS without nasal polyps, phase 2 begins in the middle of this year.
cystic fibrosis, the phase 2 PK/PD study is just read out, and we have just reviewed the exciting data for that indication. Other diseases like hidradenitis suppurativa or HS lie just around the corner for development, and we'll have more to say about those development programs as we reveal more clinical data from these ongoing studies. Turning to Slide 13. If we look at this a different way, and we just consider the numbers of addressable patients we're currently targeting from just our first two development programs at Insmed. We can see the first bar here represents refractory NTM, which we estimate will generate between $285 million-$300 million of revenue in 2023. Moving to the right of the chart, you can see the actual addressable patient populations contemplated by our ARIKAYCE and brensocatib clinical programs, which will soon read out.
The chart to the far right indicates the potential of this drug across all indications we are currently targeting. Bottom line, the first and second development programs alone hold unbelievable promise for our patients and our investors. There is more for us to cover today. Our third development program on Slide 14, treprostinil palmitil inhalation powder, or TPIP, seeks to realize the full potential of prostanoid therapy for patients across the pulmonary arterial hypertension spectrum. Recently, we had an advisory board meeting with key opinion leaders from across the PAH community, and what was affirming is that they again renewed their enthusiasm that our drug, TPIP, could become the cornerstone of therapy for PAH patients.
Their enthusiasm comes from the fact that we have already successfully dosed our drug at levels in excess of 600 micrograms, including an actual PAH patient for 16 weeks at 320 micrograms. To remind you, the highest dose in the label for Tyvaso's DPI is 72 micrograms. Our Phase 2 trials in both PH-ILD and PAH patients are underway. We hope to be able to provide updates to you this year on an interim basis of the blended titration levels a select group of these patients achieve and hopefully demonstrate their ability to reach higher dose levels, something that has not been possible historically. The ability of our drug to reach these higher dose levels on a sustained basis is the reason why doctors are so excited about the drug. Where does their enthusiasm come from?
We turn to Slide 15, we can address this issue. Long ago it was shown aerosol administration of treprostinil was much more potent than IV administration. Because treprostinil rapidly leaves the lungs after aerosol administration, continuous inhalation was required to achieve steady state of vasodilatory effect in this particular sheep model. Continuous inhalation of treprostinil is not feasible in the clinical setting, existing formulations have not been able to take full advantage of this phenomenon. What we have done is to chemically recreate the effect of continuous inhalation by producing an inhaled slow-release formulation of treprostinil. This positions our drug to take full advantage of the superior potency associated with inhaled delivery by maintaining prolonged local exposure.
Inhaled treprostinil uses the best route of administration but can't keep the exposure constant, so it can't take full advantage of the benefit of inhaled delivery. We achieve both inhaled route and constant exposure, and we clearly saw the benefits of this approach in our animal models. These included a prolonged vasodilatory effect after a single administration and superior effects on vascular remodeling. We are now attempting to replicate this in the clinical setting. We believe our phase 2 trials are designed to demonstrate this. This would be a game changer for patients with this disease, and we know from Acceleron the value of innovation in the treatment of these patients and what it represents for shareholders. We anticipate having the data from our first phase 2 study in PH-ILD patients in the first half of 2024.
Now the first three development programs, as we turn to Slide 16, are incredibly promising, all the more because they are mid to late stage and will read out their data over the course of the next 18 months. We have been hard at work extending our lead in drug development, adding platform capabilities in artificial intelligence to enhance protein engineering and gene therapy to name just two. Our goal in developing new therapies using these technologies is not just to reconstruct a pipeline for the future, but also to reduce the time and cost of drug development. We believe we have assembled the technologies to make this possible. As we turn to Slide 17 and review them, these capabilities have been assembled from several distinguished sources, and these teams have been hard at work within Insmed for well over a year.
We have pre-clinical data validating these approaches in hand today. We are targeting several therapeutic areas under the leadership of very experienced teams who have successfully done this before from our AI and protein engineering efforts under the leadership of Karl Griswold and Chris Bailey-Kellogg at our New Hampshire research facility located at the Hitchcock Medical Center near Dartmouth. To our own Chief Technology Officer, Walter Perkins, who along with his team in New Jersey, has led the development of ARIKAYCE, TPIP, and will also lead the development of next generation DPP-I inhibitors, among other opportunities. Finally, I am excited to introduce to you today the team behind our gene therapy program, the scientific and regulatory team from AveXis under Dr. Brian Kaspar, who led the successful development of what is now known as Zolgensma, the most successful gene therapy to date, both clinically and commercially.
It has literally altered the otherwise fatal outcome of patients who inherited the condition known as spinal muscular atrophy or SMA type 1. Brian and his team have been hard at work inside Insmed in our San Diego state-of-the-art facilities, developing gene therapies in therapeutic areas like musculoskeletal, CNS, and ocular diseases. We have recently augmented their capabilities with a technology acquisition that will further the impact of gene therapy in these diseases. Collectively, these are the best and brightest research teams we have come across, and very soon, you will be able to dig into their preclinical data and witness the impact of these approaches on patients as we enter the clinic in 2023.
The promise of the preclinical data we have developed is very exciting, and it shows the investments we have made to date, which have been and will continue to be very modest, are well worth it. I am confident these data and our efforts will make a very compelling case that we are on track to establish Insmed as one of the great self-sustaining biotechnology companies. We will delve into all of this in even greater detail during our research day in the Q2 of 2023. These technologies and platforms represent the engine of our future growth. Our strategy is to use the revenue from the first three pillars to fund these programs as they come to maturity.
We continue to predict that these development programs will represent less than 20% of our expenditures in the coming years, despite the fact that they will produce more than half a dozen new drugs, INDs, phase 1 trials during this time frame. This is a great return on investor capital as they prove their worth and represent the future engine of Insmed. Ours is a business that is dependent upon breakthrough innovation that helps patients. This array of talent and technology holds the promise of just that for patients and shareholders for many years to come. To summarize, as you can see, we will be busy with actual data in the next 18 months, culminating in the ASPEN results in the Q2 of 2024. Between here and there, every development program at Insmed will demonstrate its worth for patients and our shareholders.
Across the top of this slide, you see each of our programs, and across the left-hand side, you can see the timing. Within the chart, we document the many different key events which will validate our programs, thereby creating significant value for our shareholders. I wanna close by emphasizing that our culture at Insmed is what makes this all possible. As investors, this is incredibly important and an often overlooked point of distinction across great biotech companies. It is the culture underneath that makes it all possible. We have assembled great people and talent. We have given them a place to do their best work, and we have charged them, and they have charged each other with delivering on the promise of great science and clinical execution for patients. All of the great biotech companies share this, a great culture underneath their accomplishments. We have now been recognized for ours.
We stand alone with only 2 other companies in history that have ever been identified by Science's top employers list as number 1 2 years in a row. Who were the other 2 companies that earned the honor? Genentech and Regeneron. In the past year, if you can believe it, we beat out Moderna for the coveted number 1 spot, the inventor of the COVID vaccine. This should give you some idea of the promise that our company has on offer and what is yet to come. We are incredibly proud of what we built and where we are today as a company. We could not be more excited for what it is about to produce for all of you who have waited for the fruits of all these labors.
I know these past years have required patience from our investors as we have navigated the capital demands of building a great biotech company in the midst of the COVID epidemic. This is the year it all begins to pay off. Most importantly, we are excited for the patients for whom, in many cases, we are producing first in disease therapies or therapies that will have significant impact on their conditions. I invite you to be a part of this story right now if you are not already. This is the moment to do so. In advance of the readout from all of the work that has brought us to this promising moment, 2023 and 2024 are going to be the years that everyone learned about Insmed. With that, we can move to questions. Any questions from the audience?
I have one. Could you just go over the blinding data for and how you said on the phase 2, you feel more confident? Just more potential of that for us.
Sure. The question was the data from the that we just released on the brensocatib phase 3 ASPEN study, which is the event rate that is blended and blinded from that study. That range was 1.12-1.15 events per patient per year over the course of the last 3 months. The way to think about this data is as follows. We assume in the placebo arm an event rate of 1.2 events per patient per year. What we saw in WILLOW was 1.37. What we require for patients coming into the study is two or more exacerbations within the last 12 months. What you would expect to see if the drug is operating and those predictions are accurate, is a level that is in the range that we are seeing right now.
Why have we waited to put this data out until now? We wanted to know that we had enough patient data that it wasn't going to continue to move. We are now in excess of 63% of all the patient data we're gonna collect out of ASPEN in terms of patient years. We know that these ranges aren't going to move significantly from here. It is very encouraging to see 1.12-1.15 as a level. It's what we saw in WILLOW. It means the patients appear to be the same as were in WILLOW. When that happened during WILLOW, we know we were statistically significant on the primary endpoint. This is a study that is running longer. It's very fully enrolled, 90% powered to show a 30% treatment effect.
To remind you, in phase 2, we were 80% powered to show a 40% treatment effect, and we were statistically significant. We feel like we're in a very strong position with this study. You never know till you turn the data card over. No one's gonna be more excited to do that than me in the Q2 of 2024, but, so far so good. Does that help?
The inclusion, exclusion criteria between the two studies are almost identical?
The inclusion, exclusion criteria, they did not change. The whole goal when you have a successful phase 2 study, in my opinion, and you go into phase 3, change as little as possible. We're not trying to answer new questions, we're trying to replicate success. The phase 2 study was successful enough to be published in the New England Journal of Medicine. It's the first time in 20 years that they've published a result on bronchiectasis. The backbone here of this was described by the person introducing it at the American Thoracic Society as the holy grail of pulmonary medicine. This is a once-a-day small molecule pill, where the dropout rate was higher in placebo than it was in the treatment arms.
We come into this phase 3 study wanting to make sure that it looks as much like phase 2 as it can, and that we change as little as possible. We increased the power, we lowered the threshold for success, and we feel pretty good about where we are. Other questions? Please.
Yeah. On ARISE, the 15% discontinuation rate, is that something that's more reflective of what you guys are seeing in the real world? Is that a metric that maybe docs focus on as they continue to make their case in that second line?
The question was about the 15% discontinuation rate that we reported in ARISE. To put this in context, during our phase 3 refractory study, we had a 33% dropout rate. To be very transparent, we were concerned that in the frontline study, we would actually see an even higher dropout rate. These are milder patients. We thought if we give them a drug that is caustic in some way, that they will just drop it rapidly, so we could've seen a much higher rate. The fact that it's less than half is really quite shocking, in a positive way, because what it tells us is that the severity of the disease is probably contributing to that adverse event profile.
If you wait too long to treat this, it's going to be more burdensome for the patient, it's gonna be more difficult to take, and the fact that the dropout rate is now at 15%, of course, immediately means that the commercial opportunity just got bigger. More patients will be on drug, they'll stay on drug longer. The potential for that is very significant because we remember that in the frontline indication, we're already 3 to 5 times the size of refractory. Refractory today is forecast to do $285 million-$300 million. We put that data out to give you a sense of how encouraging that study appears to be at the moment. We'll have the full top-line results in the Q3 of this year. Very excited to turn that data card over.
You know, once again, the overlap between this and bronchiectasis is almost perfect. Same call point, same physicians, same community thought leaders. The dialogue we are having in the medical community right now, it could not be more robust. Does that address the question? Yeah. Okay. Other questions?
I have another one. You also implied some percentages for the Q4 as it compared to this number. It seems like it was +30%, now it's 30%. That would imply it's supposed to be a down quarter. Can you talk about what would be driving behind that outside of currency after that mention? Is there any other issues that might be slowing growth?
There was a question. The question was about the Q4 implied number, 'cause we didn't actually put out the final number. We didn't have the final number. We knew that we had set the goal of getting 30% growth in 2022. We achieved that. We did it in a year when COVID had eight different surges in Japan, when we saw a foreign exchange go against us to the tune that we lost $10 million in revenue. We didn't have to adjust that forecast or that ambition to hit 30%. We didn't report out Q4 . There are puts and takes there. There are some one-offs that may get captured in the Q4 that relate to one-time negotiations on price in certain countries in Europe.
It doesn't speak to the fundamentals underlying it. It's how we face down what is a very challenging pricing and reimbursement market environment in Europe at the moment, and in particular, in France, to be transparent. It's just a very difficult time over in Europe to get drugs reimbursed. In contrast, in the U.K., we've had a fantastic reimbursement outcome. It's very touch and go over there. As you know, Europe represents less than 5% of our revenue. Japan is really where we think the growth is gonna come from in 2023, and we're excited about the possibilities over there. We'll just have to see where it takes us.
$285-$300 as a forecast feels good coming off the end of last year. I would say that I think the fundamentals of the market for growth are very much in place for both the U.S. and Japan, and a little bit for Europe, but it's a much smaller component. Please.
Is the PAH market crowded?
Oh, yes. The question is the PAH market becoming crowded? The PAH market is crowded. I think there are 12 approved therapies to treat pulmonary arterial hypertension Group 1 patients. What's interesting about our drug is that while we're targeting that area with the goal of becoming the cornerstone prostanoid therapy choice for those patients, we are also able to go after Group 3 patients, and specifically in the PAH-ILD, interstitial lung disease population. Right now, there is only 1 drug approved to treat that, and that is Tyvaso. To put it very directly, wherever Tyvaso works, we should work significantly better because of this constant vasodilatation that we have. Tyvaso, in its original incarnation, is dosed 4-7 times a day, no nighttime coverage.
The idea of what you're trying to do is get that vascular relaxation so that you reduce the pulmonary resistance, the arterial resistance and right heart hypertrophy and the other consequent negative effects. By having a constant vasodilatation, which our drug accomplishes, you're putting the patient into a relaxed state. The sheep model showed in that vasoconstrictive model that you can return them to normal in that particular model. It's not to say we're gonna return PAH patients to normal. It's to say that that is giving us real insight that the animal model results we saw, which were dramatic improvements in these studies, should carry through to humans. We will know that by the end of this year, beginning of next year. I'm glad to be in PAH-ILD.
I wish PAH were less crowded, but we're happy to play there too. Other questions?
Okay, I'll go. Japan got off to a really great start. It was like COVID just, like, wouldn't stop. You said Japan's gonna contribute to growth next year, where do you get that confidence given kinda what's happened in the back half?
Yeah. I, you know, Japan was about 20% of our revenue in Q3 . To get there from a standing start in the midst of the COVID epidemics, display was pretty impressive. We think there's much more. The trick is we've gotta get away from the forces over which we have no control, the arrival of COVID and FX going against us. FX moved against us to the tune of $10 million last year, internationally. Now that we see the dollar weakening a little bit, stability below 140 JPY to the dollar, that should help. We think about COVID, we know it's been very challenging over there, but it is beginning to shift. We need to make sure it continues that shift, and we don't see new variants arrive.
It seems less likely to us, following the pattern of behavior that we've seen in Europe and the U.S., that it would be under the same siege this year that it was last year. That's where some of our belief is that we can make inroads. The final thing I'll say is, you know, we have taken a different approach to Japan this year. We're thinking of Japan as a relaunch. We have to be able to reach these physicians and patients regardless of whether there is COVID that is severe. We've had some time to work with that and come up with strategies for that, and we're excited to implement those. I think that's part of where the confidence is coming from.
For ARISE, I know we get kind of the big update in the back half, but you talked about in the past sort of a two-parter update where we would first hear if the PRO was working and then subsequently hear if the study worked. Is that still the way we should expect this disclosure to kinda come in two pieces?
I think we worked hard to confuse everybody with what we thought was gonna be coming out. I think we succeeded. We didn't mean to, and we apologize for that. The best intention was to describe the fascinating way one goes about building a PRO. It turns out that what people really wanna know is, does your drug work? What we're gonna put out in the Q3 of this year is very simple top-line result data. Using the PRO, did we beat the control arm? Using the culture conversion, did we beat the control arm? As we go further beyond that data and decide what are we gonna do now that we know what the results are, do we need to make adjustments for ENCORE? As you all know, we have the ability to do that 'cause ENCORE remains blinded.
That's the second phase 3 trial. ARISE teaches us how the PRO works. ENCORE allows us to make adjustments if we want to. We've already discussed this with the FDA. We would have to go to FDA and say, "Here are the changes we wanna make," and they would have to agree with those. It may not be necessary to do so, but we have that option should ARISE teach us something that we wanna act on. The way you should expect the disclosure is in Q3, a very clear communication about whether we did better than the control arm and what our plans are with the PRO from there. My guess is if we're thinking about making changes to the PRO in any way, which we have the ability to do, we would not want to talk about what those were until we had FDA sign-off.
It may take a little while for that dialogue to happen, but we'll be as transparent as we can about what we're thinking. Once we make any changes or we plan to make any changes and FDA has given us their guidance, we would definitely share that with people so people understand what, if anything, is gonna change about ENCORE. We will try to make it much clearer than the explanation that we put out previously.
Okay. Maybe one update?
One update in Q3.
Okay. We've talked about this a little bit in the past, but I'm curious how you are thinking about the way the incentives that the IRA legislation creates for Insmed.
IRA, we all know is probably the beginning of some pretty significant change across our industry. What it's likely to do in Insmed's case, and specifically, is that it's gonna help people afford ARIKAYCE. That's the first thing it's gonna do, because it's gonna cap the copays that people have to pay for expensive drugs. The second thing it's gonna do is it's going to drive us to think very carefully about how many indications to take brensocatib into, and whether it might make sense to have additional DPP1 candidates that we bring forward in the pipeline. We're looking at that right now. We need to know what IRA is gonna ultimately become before we make those decisions. In the meantime, we're sort of running these things in parallel. We have identified many diseases we wanna go after.
It looks very promising for things like hidradenitis suppurativa, for things like lupus nephritis, rheumatoid arthritis. There's a number of areas we could go to with this drug, but we may choose to do that with a successor DPP1. Any other questions from the audience?
I can't see the clock. Are we okay on time?
Oh.
Actually, I have a question on TPIP. I thought we weren't getting data on that until maybe next year, but now you've talked about like some kind of like interim update that we get in 2023. Why are you doing that?
I want people to understand where our enthusiasm for the drug comes from. Since we can't, we will put out the results, the top line results from PAH as soon as it's available. What we realize is that the secret to this drug working is getting to higher titration levels. If we know from the patient that we got who has PAH that went up to 320 micrograms for 16 weeks that that was a positive experience. What we wanna do is demonstrate that we can accomplish that across a broad range of PAH and PAH patients. Putting out interim blended, blinded titration levels, right? What is the average titration these patients are reaching? If they're up at 300 micrograms, we should win. It's as simple as that, 'cause the underlying drug, we know how it operates. It's a prostanoid.
If we're getting constant vasodilation, patients will benefit. That's what's got the KOLs so excited. We're trying to find a way to give something before the final top-line results. I mean, look, this is the way I think about the company this year. This is the year that we start to put out data on everything. Between now and 15 months from now, plus or minus, we will have data from every program running inside of Insmed. Unlike many companies where we think some programs win, some programs lose, these are all rifle shots. They're all intended to win. If that is the case, the company 15 months from now will look dramatically different than it does today. That's why I say this is the year to make a decision about whether or not to get behind the company.
Okay, we'll leave it there. Thank you, everyone.
Thanks, everyone.