Good day, ladies and gentlemen, and welcome to the AT278 clinical trial results update. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session through the phone lines, and instructions will follow at that time. I would like to remind all participants that this call is being recorded. I will now hand over to Dr. Sarah Howell, CEO, to open the presentation. Please go ahead.
Great. Thank you. Good afternoon, everybody, and thank you for joining us today. Good morning to those of you who are joining us from the U.S. So my name is Dr. Sarah Howell, and I'm the CEO of Arecor Therapeutics, and I'm joined today by Professor Thomas Pieber. And we're going to talk you through the headline results for the AT278 clinical study, and this is an investigational insulin product that's under development by Arecor Therapeutics. And so first and foremost, I'd like to take the opportunity for those of you who have not met Thomas yet to introduce him.
So Thomas Pieber is a professor of medicine and head of the division of Endocrinology and Diabetology at the Department of Internal Medicine at the Medical University of Graz, Austria, which is where we ran the AT278 clinical studies that we're going to be talking about today. He's also the director of Institute of Biomedicine and Health Sciences at Joanneum Research in Graz, also the Chief Scientific Officer at CBMed, a center for biomarker research. Professor Pieber has published extensively, more than 450, I believe, original papers and reviews in peer-reviewed journals and has made in excess of 1,000 abstracts and congress presentations during his career so far. He's won many awards, I won't embarrass you, Professor Pieber, going through those today, but he's clearly contributed significantly to this field and would continue to do so.
So you'll be pleased to hear that Thomas will be doing most of the speaking, today. So if we could just move to the Arecor Therapeutics introduction slide, please. So I'm going to give you a very high-level introduction to Arecor, and then I'll hand over to Thomas to talk through the clinical data. So at Arecor, we're very much focused on bringing enhanced therapeutic medicines to patients that can transform their care and quality of life. We do this by leveraging our innovative and proprietary formulation technology platform, Arestat. So we're here developing novel formulations of existing therapeutic products which have enhanced properties. So we're focused here on improved efficacy, safety, and ease of use, so lowering burden for patients and caregivers. We have a very diverse and de-risked portfolio of both partnered programs and also in-house proprietary programs.
On our partnering programs, this is where we partner with major pharmaceutical and biotech companies to enhance therapeutic products, which they then further develop and take those to market. And most notably, their first product, incorporating the Arestat technology, was launched by one of our partners towards the end of last year. That's important because it demonstrates the developability, developability and approvability of our technology, the benefits that it can bring to patients, and of course, the commercial value. And for Arecor as a company, important because that's now generating recurring royalty streams under a worldwide license agreement. Within our own proprietary pipeline, we're very much focused in areas of high unmet patient need in large markets, and as you can see, we have research areas in diabetes and obesity.
So we have two clinical-stage insulin products, AT247, and subject to today's call, AT278, and also an oral GLP-1 program that's preclinical. Most recently, we announced a collaboration with Medtronic to develop a novel formulation of insulin that's compatible with implantable insulin pump delivery there, which is important need within a specific patient population. So at this point, I'll hand over to Thomas, who will talk us through the AT278 and clinical data and relevance of that to patients.
Yeah. Thank you, Sarah, and welcome to everyone, and thank you for listening. Can you move, please, to the next slide? And just to the next. So I will start here with the kind of paradigm shift that we are currently seeing, and that is that there is a quest for having insulins, not only ultra-fast for prandial coverage of the meals, but also have more ultra or higher concentrated insulins. So why do we need them? Well, first of all, we would like to allow administration of higher doses in a smaller volume, which comes along with convenience. We also would like to avoid the splitting of subcutaneous injections in people with higher insulin needs. And then... and I think this is where we started.
There's also the concept that we could develop much smaller and smarter pumps if we have a higher concentrated insulin. And AT278 is a novel formulation of an ultra-concentrated insulin. It uses the Arestat formulation technology you just have heard about. It has a concentration of 500 units per ml compared to the 100 units per ml, that's the standard. And it has been designed to maintain the rapid action characteristics of the U-100 insulin AT247, which would offer a reduced insulin dose volume. Next slide, please. So when we started out, I think the vision was, and still is, that we have with a fully closed-loop system, we also have a smaller insulin pump systems for children, young people, which allows discreet insulin delivery.
And for that, the U-100 insulins, as we have them right now, are currently a bottleneck. So from the perspective of insulin pump therapy, a higher concentrated insulin is extremely attractive. Next slide, please. I first would like to review or recap on the first trial that we did 2 years ago. This was done in type 1 diabetic patients. It was a euglycemic clamp study, and I'll just show you the results because they have been published. And then I will present to you the new results. Next slide, please. So the 1 0 2 study with the compound AT278 was a phase 1 study. It was a single-center, single dose study.
It was a randomized, double-blind, two-way crossover trial, where we used 0.3 units of either the new insulin, AT278, with a concentration of 500 units per ml, or NovoRapid as a standard comparator. We did a euglycemic clamp study, and we did this study, as you usually do with new insulins in a population of type 1 diabetic subjects, which were kind of a standard type 1 population. Next slide, please. These are the baseline characteristics. So they had an age of 39 years, BMI of 27 on average, well controlled, with an HbA1c around 7, and they were almost completely C-peptide negative, as you would expect from a type 1 diabetes population. Next slide. Shows you already the results. So these are the pharmacokinetics.
So this is the appearance of insulin in circulation. On the left side, you see the full 8 hours of our study, and on the right side the first 2 hours. In gray, you see the insulin aspart in a concentration of U-100 units per ml, and in yellow, you see this new formulation, AT278. And despite this much higher concentration of insulin, we saw a significant shift to the left side with an earlier onset of action, with an earlier half maximum concentration, and with a substantial earlier peak concentration. And if you compare that insulin profile against other insulins that are currently on the market, with the U-100 units concentration, not only it's higher concentrated, but it also has a substantial left shift. This is the pharmacokinetics.
The next slide shows you the pharmacodynamics of that clamp study. You can appreciate again, on the left side, the full 8 hours of the clamp study, on the right side, the first 2 hours. You can appreciate that not only we saw an early appearance of insulin, but also, as you would expect, of course, was a much earlier effect of that insulin when it comes to pharmacodynamics. Next slide, please. If we summarize this study that has been done, this phase 1 study that has been done in Type 1 diabetic subjects, so this new formulation is of concentrated insulin aspart, with a concentration of 500 units per mL. It showed an enhanced early insulin exposure, compared to NovoRapid, with a 6-minute early insulin appearance and 23 minutes faster half maximum concentration.
Just to illustrate, so for Insulin Aspart, the half maximum concentration was achieved at 30 minutes. With AT278, it was achieved after 7 minutes. This is this 23-minute shift. There was a 44 minutes faster T max, maximum, time to maximum concentration. And if you look at the first 30 minutes, there was a 4-fold higher insulin exposure within the first 30 minutes. It also showed an accelerated early glucose-lowering properties, 10 minutes earlier onset of action, 20 minutes faster half maximum action, and 2-fold higher glucose-lowering effect within the first 60 minutes. AT278 showed a comparable overall insulin exposure, so the unit per unit translation was the same with the glucose-lowering properties when compared to NovoRapid, and it was well tolerated.
And the highlight is now that I can move to the next study. Next slide, please. Where this was investigated now in another population, and these were people with obesity and type 2 diabetes. Why have we decided to do this study? Well, there's not only the quest for highly concentrated insulins when it comes to pump development, there's also a need for a growing population that has large insulin needs. And currently, the only concentrated insulin that is available is regular insulin, Humulin R U-500, which has a concentration of 500 units per mL, but has a very slow onset of action and a very flat profile. It mimics more a basal insulin than a prandial insulin. And if you look at the market, there are no fast-acting insulins with high concentration available except the U-200 preparations that we well know.
So in this study, again, it was a phase 1, single center, single dose, randomized, double-blind part, where we were comparing AT278 against Insulin Aspart. And then we added an open extension, where we tested it also against Humulin R U-500. The next slide shows you the study design. So in the blinded version, this was a blinded crossover trial, so patients were either receiving first AT278 and then NovoRapid, or first NovoRapid and then AT278. This was the blinded part of the study, and then we invited all the subjects also to continue, because we also wanted to see how this new insulin preparation compares against the only U-500 insulin that is available, which is Humulin R U-500.
So we screened 69 subjects, 41 were randomized, and you can see it on this exposition, how many of the subjects were concluding that study. Next slide, please. So these are the baseline characteristics. So these were standard obese type 2 diabetic population, so they had a mean age of 63 years, a body weight of 93 kilograms. More important, their BMI at the median was roughly around 30, so the range from minimum to maximum was ranging from 25 all the way to 38.7, with a median of 29.7. Diabetes duration was 18 years. They all were using insulins, and HbA1c was 58 millimoles per mol. So this was a patient group with a high BMI, and why have we chosen this?
Well, we do know from other insulins that the more obese you are, the slower the onset of your insulin gets when you inject it. There are different mechanisms behind it, and the questions we wanted to ask, if this new novel Arestat formulation, if that also would delay onset of insulin action or if that Arestat preparation can maintain fast onset in a highly concentrated insulin, as we have seen it, in the Type 1 diabetic population. Next slide, please. So I'm moving now to the results, and I can present here only the headline results. Next slide. So overall, AT278 demonstrated a significantly accelerated PK/PD profile compared to NovoRapid, which was the comparator in that study, and compared to the Humulin U-500 preparation in people with Type 2 diabetes and high BMI.
It exactly confirms or copies almost, I would say, and you have seen the curves before, it confirms the previous trial that we have performed in patients with Type 1 diabetes, where we could demonstrate this fast onset and superiority against the standard insulin preparations. And with that new results, we can claim now that this fast onset of this highly concentrated insulin is maintained irrespective of diabetes type and body mass index. So the trial specifically met all primary, it met the primary endpoint for non-inferiority with respect to glucose-lowering action compared to NovoRapid. But it also demonstrated a significantly accelerated PK/PD profile, compared to NovoRapid and compared to the Humulin R U-500 insulin.
And overall, no safety signals were detected, so we have, I think, the exciting news that this Arestat formulation allows a very fast, fast onset of insulin action, not only in type one diabetic patients or in patients with normal BMI, but also in patients with high, and very high, BMI. Okay, next slide. Why are those results so important? Well, I think we all are experiencing a growing number of people with diabetes that require high daily insulin doses. We all know that obesity-induced insulin resistance leads to these highly daily insulin requirements, and this is definitely an issue in patients with type two diabetes, but also increasingly nowadays in patients with type one diabetes.
And there's a need to deliver high insulin doses for patients with high insulin requirements, either via multiple daily injections or in continuous subcutaneous insulin infusion. And currently, we don't have a fast-acting insulin that has a concentration of 500 units, because, as mentioned, the regular insulin preparation, which we also were comparing us against, definitely does not provide a fast-acting onset, if it's used in this high concentration. So next slide, please. These results are also important for pump users. So we have seen already in type 1 diabetes that this insulin has a very fast onset, which is very attractive for automated insulin delivery.
Pump therapy becomes more and more relevant for patients with Type 1 diabetes, but probably also for patients with Type 2 diabetes in the future. The size of the pump that we currently are using matters. A smaller pump definitely would provide an easier access to pump therapy. With this new insulin, we really have a leap forward. Not only we have a highly concentrated insulin available, we have a highly concentrated insulin available for both Type 1 and Type 2 diabetic patients, irrespective of the BMI that those patients have. Okay, next slide. With this superior PK/PD profile, I think AT278 has the potential to significantly improve the postprandial glucose control and lower the burden. I mean, anybody with diabetes who has a high daily insulin need.
We also believe that it can act as a catalyst for the development of small pumps and small pump systems, and we and others are working on that. Especially because the size of the existing devices is indeed a significant barrier for insulin pump use in many patients currently. Yes, the next obvious study would be that we now investigate the usability of AT278 in continuous pump therapy, because this study, I have to remark that here, this study was a single injection study, which usually do as a first step. But yes, we are all looking forward to investigate now AT278 in continuous insulin infusion in our patients. Next slide.
With that, I want to thank for your attention, and I'm handing back to Sarah.
Great. Thank you, Thomas. So can we go to the next slide, please? Yeah, so I was just going to talk a little bit more, I think, as Thomas has talked us through the clinical data across the Type 1 and Type 2 patient population from the two phase one clinical studies that have been conducted with AT278. I want to talk a little bit more around the needs of these patients, the prevalence across the patient population, and a little bit more about the market dynamics here. So I think as Thomas just mentioned, you know, as we're seeing increased insulin resistance, which is also increasing as we see obesity and BMIs increasing in this patient population, we're seeing a growing number of people with diabetes require this high daily insulin need.
I think as Thomas has spoken about, there aren't any very highly concentrated, rapid-acting insulins. And the reason for that, and the challenge here, is that as you concentrate up insulin, it blunts and flattens out its time action profile, so it becomes much slower acting. And that's what Arecor have been able to overcome and achieve with this novel formulation of insulin. So it's a highly concentrated, very rapid-acting insulin. So for people who require insulin to manage their blood glucose on a daily basis, so that's all of Type 1s and for Type 2s that have progressed through to requiring insulin, we're looking at a patient population on what are called intensive insulin therapy. So this means that they require a mealtime or a very fast-acting insulin to control their blood glucose around mealtimes.
If we look at the U.S., now, there are around 4 million people with diabetes in the U.S. that are on this intensive insulin therapy. Around half of them have Type 1 diabetes, and the other half have Type 2 diabetes. In this patient population, around 60% of those Type 1s and majority of Type 2s currently use what we call a multiple daily injection regimen here. So that they are using a basal insulin to manage their background insulin and then injecting a mealtime insulin or a prandial insulin three times a day here.
What we can see for AT278, for those patient populations that are requiring these high daily insulin needs, which you can see on the left-hand side here, in the U.S., it's approaching nearly, on average, 100 units a day for the average Type 2 diabetic patient. But AT278 offers a number of benefits here. We have the superior efficacy, so the PK/PD data that Thomas has spoken about, to enhance that and improve that postprandial blood glucose control around those quite difficult to manage mealtimes. Really importantly, is around lowering the burden as well. Managing diabetes for both individuals and caregivers is a high burden disease. It's obviously a chronic disease. It's 24/7 management here.
So really, if we can lower the burden through lower injection volumes, potentially fewer injections a day, and certainly reducing the number of pens that you need to carry around with you, then we can drive compliance and adherence and improve outcomes there. Also, with that superior efficacy enables flexibility around dosing, so you can dose your insulin after you've eaten, for example, so you know exactly how much you've eaten and at what time you've eaten, so you can better manage and control your blood glucose. Cost is clearly important here, so there's a real drive towards reducing that cost burden to patients. So in the U.S., this is around co-pays and the insurance and of course, to payers. Now, AT278 has the potential here to reduce the cost to patients.
You, you're gaining more insulin per prescription, so that reduces that co-pay, and we'd expect it to be at least cost neutral for payers here. You would see... If you see improved compliance, adherence, and outcomes, that, of course, improves patient outcomes and reduces their burden and cost to those payers. So if you can have the next slide, please. And what we're really excited about here is the ability and potential for AT278 to enable that next generation of smaller, so miniaturized, very small, longer wear pumps. So if we look on the left-hand side here, there's great technology in place, both in insulin pumps, the algorithms, continuous blood glucose, and monitors, and this move towards what we'd call hybrid closed-loop systems, which help people with diabetes manage their diabetes on a day-to-day basis.
What we do know from clinical data and real-world data is that people on intensive insulin therapy who use insulin pumps, their outcomes are better. They have better control, there's a lower burden, and for them, an improved outcomes. But despite this, there's still a significant number of people who don't use insulin pumps. So in the U.S., there's only around 40% of Type 1s and less than 10% of Type 2 people on intensive insulin therapy use an insulin pump. And part of this part of the barrier to use is the size of the insulin pumps and their burden of use.
So if we can here play our part in terms of reducing that barrier, so helping to miniaturize those pumps and enable longer wear pumps, so less interaction, less changing over of pumps or cartridges, then there's an opportunity here to expand their use, particularly in Type 2 diabetes, where that penetration is very, very low. And really, this is a drive around if we can move patients over to insulin pump therapy, we can see that improvement in time and range, or that time spent in their healthy blood glucose target range and improve those outcomes. And in doing so, of course, expanding the number of patients in that market share within the insulin pump therapy. So can I have the next slide, please?
So, really, I was just going to talk about here in terms of the summary and next steps associated with AT278. So as we've heard about today, AT278 is the only insulin that we're aware of, and certainly the only insulin published, that's achieved this very highly concentrated, ultra-rapid acting profile here. We demonstrated that best-in-class superiority data across two clinical studies now in Type 1 and Type 2 diabetes. And it really does have the potential to meet, yeah, significant unmet patient need, both for high daily insulin users, so that's both Type 1s and Type 2s, and also that next generation of miniaturized and longer-wear pumps. In terms of the market opportunity, the intensive insulin therapy market, so the insulin alone is an existing $6.4 billion market.
So of course, there's an opportunity here with a superior best-in-class insulin to improve outcomes for patients and also gain market share within that existing market. And of course, if there's an opportunity there to increase pump use across that Type 1 and Type 2 population, we can also expand that use and expand within that market. And the current insulin pump market is valued at around $5.5 billion, and is expected to grow to greater than $15 billion in the next 5 years or so. And I think there's a real opportunity here to really catalyze that next phase of development of those miniaturized, longer-wear pumps. Now, of course, we've only just received the data.
We announced those headline results, as you know, on Monday, so there will be a full analysis across the company of those clinical results so that we can determine that best pathway forward now for the next development of AT278. With our goal here to ensure that we can bring this new insulin and improved insulin to patients. We will be planning to submit the detailed data for publication and will be hoping to present the data at a future major diabetes conference. Next slide, please. That concludes the formal presentation for today, but we'd be very happy to answer any questions that anybody has that's on the line today.
Ladies and gentlemen, we will now begin the question and answer session. We will now begin with questions from the phone line. To ask a question on the phone line, please signal by pressing star one on your telephone keypad. We will pause for a moment to assemble the queue. Our first question comes from Julie Simmonds, from Panmure Gordon. Please go ahead. Your line is open.
Hi, Sarah. Just, I suppose that I know you can't give us a sort of full comparison between the two trials at the moment, but I'm just wondering if you can give some indication of whether there would have been any expected difference between a Type 1 diabetic and a Type 2 diabetic when you're looking at other insulins historically.
Thomas, do you want to take that?
Yeah. Yes, this is an important question. Thank you. So, we do know that, the leaner or the slimmer someone is, the faster his or her insulin acts. We do know that already in Type 2 diabetes, with the U-100 insulins, we have a delayed onset. Fast-acting insulins are slower in Type 2 diabetic patients than they are in Type 1. That's one thing. The other fact is that higher concentrated insulins are usually acting much, much, slower, so the onset is delayed. A peak action is very delayed. This is, this is one of the reasons why there is a standard concentration of 100 units per ml, with some of the insulins going to 200, which is, I think, the ceiling in the current insulin market.
And here we have a highly concentrated insulin with 500 insulins, and the expectation was it's fast in type 1, but might be much less fast in type 2. But to our surprise, I think the positive findings are that this action profile is maintained in both diabetes types, and it's maintained irrespective of the BMI. So when you compare a large population with different BMIs, you see the more obese someone is, the slower the insulin gets, and this is not the case in this new insulin.
Lovely. Thank you very much.
Our next question comes from Karl Keegan from Singer Capital Markets. Please go ahead. Your line is open.
Professor Pieber, Sarah, can you hear me okay?
Yes.
Yes.
Okay. So a question for you, Sarah. You recently announced the signing of a collaboration with Medtronic, which is obviously one of the major pump players. Do you see this as a sort of an uptick in interest from Medtronic and other major players into the novel insulins? And if yes, and I do think the answer is yes, but if yes, what do you think is driving that?
Yeah, thanks, Karl. So, you know, I think here, you know, obviously, the device companies, the major device companies are, are coming at the treatment of diabetes from the technology aspect. So insulin pumps, continuous blood glucose monitors, you know, huge example of advancements in algorithms as well. And, and their drive is really around, you know, improving time in range, reducing burden for patients, improving time in range, giving them much better control, while making that as, as easy to use as an interface as possible. So we've got these hybrid closed-loop systems, and that's very much the focus of Arecor as well. But we're looking at it obviously from the insulin basis. So, you know, what we're bringing to patients here and the opportunity here is if we can develop a much faster acting insulin.
So as we've seen that with the superior kinetics, say, the PK/PD, but also in this case, a very highly concentrated, rapid acting insulin, then you can combine this with the latest technologies in terms of the insulin pumps and the algorithms to get the most out of those kinetics. And again, see a further step change in that improvement in time in range and help, you know, improve that control whilst lowering the burden of patients. So I think we're very much aligned, there with the ultimate goal, improving outcomes for patients, but coming at it obviously with different expertise and different innovations bringing to the table.
I think, you know, we can see from, you know, public domain announcements from the major device companies, so, you know, Medtronic, Insulet, Tandem, you know, there's very much drive there in terms of bringing insulin pumps and formats, ease of use, lowering burden, to help patients transition on that journey and transition over to insulin pump therapy as well. You know, we're very much aligned, and we can see from the data and real, real world use, that you see improvement in outcomes there. We think AT278 has a very significant role to play here. As we've said, if you want to have a much smaller, longer wear pump, you need a concentrated, rapid acting insulin. Otherwise, you know, that becomes the limiting step to achieving that profile.
Yeah, and if I may add here, if you allow. So in the past, the technology companies, the pump companies, said, "As long as there's no insulin we can use, there's no concentrated insulin we can use, why should we develop a smaller pump?" But that insulin is now available. That's here. And that triggers a huge interest in pump companies to be one of the first to be able to provide this new, better technology within higher concentrated insulin. So I think, we are really getting into the next level here.
Thank you.
Our next question comes from Max Herrmann from Stifel. Please go ahead. Your line is open.
Great. Thanks very much for taking my questions. Hopefully you can hear me, and congratulations on the data. Really, it's just a question, a couple of questions. One is on, obviously, repeat dosing, which you talked about. And then it's kind of what is the route to commercialization? You know, obviously, the active is well understood, and this is more of a formulation. So is it a 505 B2 type route to market, and what are the next steps? Thank you.
So-
Yeah.
Yeah, I was going to say, I didn't know whether you want to take the first question, first part of the question, Thomas.
Yeah, well, okay. I couldn't hear it correctly. Maybe you can start, and then I-
Yeah, so maybe I'll talk about the you know, the commercialization pathway. So I think it's a key question. Thank you, Max. So, you know, what's important to note here is that we're taking existing insulin, so we're using insulin aspart in this case. So it's the insulin used in Novo Nordisk products, such as NovoRapid. And this is important because it means that the safety and efficacy of the insulin, so the active, is already known. And that's key because it means now that we can follow an abbreviated regulatory and development pathway to market. We're not having to-- we're not needing here to prove the safety and efficacy of insulin itself.
The reason we're conducting clinical studies here, of course, is because we are aiming at demonstrating superiority and demonstrating that AT278 can bring additional benefits to this patient population. So that's, that's very much the focus of our clinical studies. So in terms of pathway to market, there's a requirement still to do a phase 2 and a phase 3 studies, but these are much smaller studies. I mean, you will have noticed from the patient numbers from our phase 1 clinical studies, this most recent study was 39 patients, and that's really powered for us to be able to demonstrate superiority there. So you can demonstrate superiority with just 39 patients with AT278. So, you know, a phase 2 study, again, is, is small and contained there.
You're looking at less than 100 patients, and then you're looking at hundreds of patients, not thousands, for a phase 3 clinical study. So it is an abbreviated pathway to market there.
Yeah. And so, yeah, so the studies that have been done were single injections. One of the next obvious steps would be to take AT278 and put it into a pump and provide it to patients with higher insulin needs, so which, where you can take the existing pumping mechanisms and give a fifth of the dose because the insulin is five times concentrated. And again, looking to PK and PD after one day, two days, and three days, which is the usual wear time for insulin infusion catheters. And to demonstrate, yeah, efficacy and safety of that new insulin in a pump in patients with a higher insulin need.
You won't choose patients with a low insulin need in the beginning because that pumping mechanisms that are currently on the market might not cover the much smaller bolus you need in the future. But that is under development. So the next step definitely is, as I said in my presentation, doing a test of this new insulin in pumps and see, and look on efficacy and safety.
Our next question comes from Samir Devani, from Rx Securities. Please go ahead. Your line is open.
Hi, thanks for taking my questions and for the presentation. I guess I've just got two. Could you just comment on whether you saw any cases of mild hypoglycemia in the study? And the second question is, are you aware whether Novo or Lilly are internally working on high conc formulations? Thanks very much.
The study was a clamp study, so in a clamp study, glucose is controlled very tight. In that setting, you are not getting any hypoglycemias. It was a single-dose study, so we did not give the compound for a longer time yet because this was too early. This was a phase one trial. What would you expect? When we shifted from regular insulin to short-acting insulin, overall, as soon as patients understood the faster profiles of those insulins that are on the market, the clinical trials were showing less hypoglycemic events. We also would expect within faster insulin as we have it here in our hands, at the end of the day, same glycemic control, but less risk of hypoglycemia because the insulin exposure after meal is shorter.
So this was this one, and the other part of your question, sorry?
It's around if, we're aware whether Novo ;
Yeah. So, well, I think we know that one of the two companies is working on a better pump insulin, because the product they have on the market has some limitations in pump use. It has to do with the additives in those faster-acting insulins. They are causing inflammation and pain and early failure of the insulin infusion catheter. So definitely one of the companies is working on a better insulin preparation. Yes.
Samir, specifically on your question around the highly concentrated, you know, I, I think, you know, you can never be sure what's happening in internal development, but certainly in terms of published data, intellectual property, there's no indication of anybody else, another company or research institute being able to achieve a highly concentrated, rapid-acting insulin. I mean, this is a particularly difficult challenge to overcome. It's, it's really our, of course, USP here around using its Arestat technology to enable these profiles that are otherwise unachievable. So we're not aware of any other highly concentrated, ultra rapid acting insulin, and I think that's really the key here. It's that unique profile meeting those, you know, very specific needs that we've spoken around, about that high daily insulin need, and that's miniaturized next generation pumps there.
So we believe we're in a market leadership position there.
Yeah. There are good reasons why, Novo Nordisk is only providing rapid acting insulins in concentration of 100 units, and Eli Lilly is having their compounds, Lispro and the fast Lispro, with the 200 units per ml concentration. Because with basic technology, you cannot concentrate higher because you're losing your fast acting profile very fast, and we see that, with the regular insulin, also with the highly concentrated. So in a sense, this is a very unique insulin because you can concentrate it up to very high concentrations, without losing the advantage of being a fast acting insulin. And that's, this is not an easy task to handle. And, the Arestat platform seems to work well. And that's, I think, a unique, it's this is truly unique.
Our last question today will come from Franc Gregori from Trinity Delta. Please go ahead. Your line is open.
Thank you. Professor Pieber, you, I, I understand what you're saying, that this could potentially be the critical enabler of the new smaller pumps, miniaturized, more convenient. I get all of that. But can you tell me, what is the need that we currently have? You mentioned that the basal, bolus people, the injectors need it. As a clinician, how many people are you seeing that need that? How many would you be using it for? And also, can I ask where GLP-1s come in? It's good to have a clinician here. Where do you see the role of GLP-1 in Type 2 evolving? Will this affect the need for a high concentration insulin?
Very good questions. Thank you. So, I mean, so if you ask patients what they, what kind of pump they would like to have, and we did a survey with, patients, so people with diabetes and their relatives, there's always three major things: the pumps should be smaller, the pumps should last longer, and the pumps should be smarter. So patients really want to have a, a pump therapy that takes out the burden. And when it comes to wear time, currently, when you use 80 units per day, or 70-80 units, which is, like 30% or 40% of Type 1s are using 80 or more units per day. You have to change your reservoir every three days because usually the pumps have a reservoir for 300 units.
So with a higher concentrated insulin, wear time could be substantially longer. You also need a catheter system that you can wear longer, but this is achievable. That has been achieved already. Medtronic, for example, has a catheter that you can wear for a week. So with that, you can envision a small pump with smart technology that you change every week and not every 2 or 3 days. You have also patients who need 200 or 300 units per day, and they have to change their reservoir every day. And it's so costly for them that they stop using a pump. For them, a higher concentrated insulin definitely would be a relief.
Regarding the future of Type 2 diabetes therapy, I'm with you that GLP-1 receptor agonists and dual hormone agonists that have a major impact on weight are very intriguing and interesting. If you look at the market share, it's currently 8% of all Type 2s are using GLP-1 receptor agonists. There are certain side effects, and there's a pathophysiology that also is relevant, and that is that the longer your Type 2 diabetes goes on, the more you lose your endogenous insulin secretion. So yes, you're right that in the early phase, GLP-1 is a very good alternative, and it's used worldwide. But if you have long-term Type 2 diabetes, many of them are ending, or have to use insulin. Currently, 40% or more are on full insulin therapy.
For those subjects, and this is 40% of the market, a highly concentrated insulin with a smaller injection volume in general, and for those who need large insulin doses, this concentrated insulin is quite attractive.
We have no further questions. We will now hand back over to Dr. Howell for closing remarks.
Great. Thank you. So first, firstly, thank you, Professor Pieber, for talking us through those results today. As we said, we will be publishing those in full, and once they're available in full, we will no doubt have another webinar to talk through more detail around those study results. And thank you for everybody joining today, and please do feel free if anybody has any questions outside of the webinar today, please do get in touch. And I believe the webinar will be available to view as well on our website. So thank you for joining us today, and we look forward to updating you on next steps.