Good morning. My name is Dr. Nina Webster. I'm the CEO and Managing Director of Dimerix. For those of you not familiar with Dimerix, we are an ASX-listed company, code DXB, and we're working in the space of inflammatory diseases, in particular kidney disease and respiratory disease. Please note forward-looking statements as I go through today. Just for note, what is the key asset that we're working on? This is a phase three clinical study in a disease called Focal Segmental Glomerulosclerosis, or FSGS. That's a rare type of kidney disease, and it's a kidney disease for which there are no treatments available anywhere in the world at this time.
Fortunately, we have what's called orphan drug designation for that disease, and that gives us a number of different advantages, including a faster pathway to market, particular pricing incentives, as well as market exclusivity once we get to market as well. The product is called DMX-200, or QYTOVRA in some territories, as we get closer to market. It's also a candidate for which we do have four commercial marketing partners around the world, and I'll come on to those just shortly as well.
In the background of all of the activity to bring us towards that phase three clinical trial is a huge amount of effort and outcomes, and a lot of that is around those preclinical activities, the manufacturing we have scaled up for commercial manufacturing, and we are manufacturing in the U.S., as well as the phase one, phase two clinical trials, which showed really strong safety profile, but also very encouraging efficacy, which has led us to that phase three clinical trial, which is the last one before we go to market. In the background of that phase three clinical trial, we are working with the F D A and a working group called Parasol, which I'll also come back to in just a moment, in bringing forward what those endpoints might look like for the end of this clinical study.
There's a lot of activity happening behind the scenes and a lot of outcomes that we can look forward to in the very near future, which I will just touch on in a moment. What I'd like to do, though, is just take one step back and talk about what is FSGS. FSGS literally means some sections of the kidney are scarred. What happens over time is more and more sections become scarred until there's not enough left to filter the blood, and you end up in kidney failure. Sadly, for these patients, it can affect children down to two years old, as well as adults. Once they hit that kidney failure, the only solution there is dialysis and/or transplant. In this particular disease, for those who do get a transplant, around 60% get reoccurring disease in the transplanted kidney. Not a solution.
What happens in this disease, and we start at point number one here, is patients present typically with that high blood pressure. That high blood pressure causes a lot of pressure buildup on the kidney vessels. Those kidney vessels under pressure come to point number two, causing inflammation of those cells. Those cells, because that inflammation is ongoing and persistent, become scarred or fibrotic, which leads you to point number three, where those cells die off. Kidney cells are not like other cells in the body because they can't regenerate. That means once you've lost those cells at point three, you can imagine you now come back to point number one with fewer cells, working even harder, causing more pressure, causing more inflammation, causing more cell death.
You go round and round this cycle faster and faster, each time with fewer and fewer cells until there's not enough left to filter the blood and your kidney fails. This typically, from diagnosis, can be less than five years. It's a very aggressive disease. The current standard of care for point number one is a blood pressure medication. It's called an angiotensin receptor blocker, and that's there to help drive down that pressure on the kidney vessels. Our drug, DMX-200, or QYTOVRA, works at point number two, and what we are doing is driving down the inflammatory component and therefore preventing the scarring and fibrosis. This is important because in context of our clinical trial, the patients stay on their blood pressure medication. That's really important. We add in our drug to those patients to drive down that inflammation.
Jumping on to the key things that we measure in our clinical trial, and this is really important, is those surrogate endpoints. Surrogate endpoints are markers that help determine how your kidney function is performing. The first one is eGFR, or Estimated Glomerular Filtration Rate. eGFR literally means how many milliliters per minute is your kidney filtering your blood. When we're all born as babies, we all have an eGFR of about 120. We sit up here, and every day we sit here, our kidney function is declining, and that's the black line represented in this graph. As that declines over time, most of us, though, you can see where it intersects with the red line, which is kidney failure. Most of us will be long gone from this earth before that ever happens. With FSGS, that eGFR is crashing, and that's represented by the green line on this star on this graphic.
The star on this particular graphic is about age 45, and that's because it's the average age in our clinical trial. You can imagine that if you were a child, two years old, that's when the green line starts crashing, or older, that's when it starts. It's really aggressive and when it declines. Drugs like DMX-200, what we're trying to do is move that green line back more in line with natural aging. The black line can't go back up because it's a progressive disease, but we can bring that trajectory back more in line. Imagine for those who do come back in line, if they were diagnosed at 45, they could actually hit end of life without requiring dialysis, which is a massive outcome.
Even if you only move that line a little bit, what you can see along the bottom there is you are buying years on the patient's life, the patient's kidney. That's years without requiring dialysis, cost of healthcare, but also quality of life. It's a really important outcome for them. The second surrogate we look at is something called proteinuria, and that's literally protein in the urine. The healthy person, the kidney is a really good filter. It filters the blood, and you should see little or no protein spilling into the urine. As the kidney becomes damaged, it's under pressure, the cells are forced apart, and then you get some of those cells dying off. It becomes quite leaky, and you end up with protein spilling from the blood into the urine.
We know that the amount of protein in the urine is a measure of how fast is your kidney disease progressing. If you can reduce the amount of protein in the urine, it says you are slowing down the rate of kidney disease progression. These are two particular surrogate endpoints, really important in the clinical study that we're running because they tell us how is the kidney functioning and whether we are slowing down the rate of kidney disease progression. Just jumping into the design of our phase three clinical trial on the back of some really encouraging phase two data. Looking at the graphic on the bottom here, these patients are randomized to drug or placebo, and all of them are on that background of that blood pressure medication, the angiotensin receptor blocker.
That full study is a two-year study, and we are collecting both proteinuria and eGFR throughout the whole study for these patients. Ultimately, we aim for around 286 patients, and as of today, we're around 225. You can see that we're well and truly on our way towards full recruitment for the clinical study. In this clinical study, because it is an orphan disease, two interim analyses are built in. The first one we completed last year, where we saw a really encouraging outcome, patients are doing better on the drug than placebo. It is a blinded analysis, so we don't see specific data. What we know is they've hit a certain threshold, and what we don't know is whether we just met it or we've blown it out the water. We know that the drug has separated from placebo and is doing something.
The second analysis at the moment is termed what we call another blinded analysis, and that is looking at the statistical and that powering of the clinical study, but also may be able to give us the opportunity for what we call an accelerated approval. Looking at what that means is where this project Parasol comes in. By way of context, when there is nothing approved in a particular indication anywhere in the world, what happens is as new information comes to light, the endpoints for those clinical trials can be adjusted to meet that new information. A working group led by the FDA was put together late 2023 through 2024 to look at FSGS specifically and what the appropriate endpoints could be for FSGS. It was confirmed that eGFR is a validated endpoint, so you can see eGFR at two years.
They also recognized in that study that you can use protein in the urine, proteinuria, which is a much easier endpoint to hit from the context that it typically changes in a faster period of time, and therefore you would typically need less patients to be able to see it. That is a really encouraging outcome. That analysis was done at 24 months. What we are doing, Dimerix is working with that Parasol group right now to have a look at if you need to see X at 24 months, what do you need to see at 12 months to be able to see an accelerated approval? That is the project that's running at the moment. Now, the steps to get there for that decision is the first thing is getting the outcome from that Parasol working group.
That should be around one to three months, and we should be able to get the outcome of is there a correlation between an earlier time point, such as 12 months and 24 months, and essentially the risk of progression to end-stage renal failure or kidney failure. Assuming we get that correlation, we will then be able to take that to the FDA to get confirmation. Do they agree that the correlation is strong enough to get an earlier approval for FSGS accelerated approval? We then do an analysis because we have to preset the endpoints before we can do analysis. That's really important. Otherwise, we risk the integrity of the study. The endpoints are preset. Once we've done that, we do our analysis.
We can check on our statistical powering for the clinical study, and at the same time, we'll be working through, based on the outcome from the FDA and Parasol, whether we are going to be looking to do any unblinding and accelerated approval. That process is expected to happen over the coming months, with the outcome expected around the end of this year into potentially the early next year. We're talking predominantly there about the FDA, but what's really important is putting that into context that in other territories, they still want the eGFR for the two years. We are collecting both proteinuria and eGFR all the way through. There is also potential for those faster pathways in some of those other territories as well, including in Europe and Japan, which are under discussion with the regulatory authorities in each of those territories as well.
Now, just jumping into the potential market for here, we mentioned at the start that this is a rare disease, but it's not ultra rare. It's actually very difficult to get the complete prevalence. Prevalence is the number of patients suffering at any one time around the world, and that's because it is driven by biopsy, which is a surgical procedure. Put that into context. When there's very little treatment for kidney disease, as there has been for over 20 years, it meant that once you were diagnosed with kidney disease, there was no burden on the physician to work out which kidney disease. It didn't matter. There were no treatments for any of them. As treatments are becoming available for the different types of kidney disease, what we're seeing is biopsy rates starting to increase, and therefore the prevalence is likely to increase as well.
What we can see more clearly is what we call incidence. Now, incidence is the number of new patients in a specific period of time. What we can see here is the estimated incidence of patients around the world. As it's growing each year because the biopsy rates are going up, we're seeing more diagnosis. This is a really commercially attractive opportunity globally, given that per capita the incidence of FSGS is relatively uniform around the world. Now, again, putting that into context of the commercial opportunity here, there is nothing approved for FSGS. There's no pricing reference for FSGS at the moment. A different type of rare kidney disease called IgA nephropathy, there are four products approved. You can see it on the graphic on the right-hand side here. They retail anywhere between $120,000 and $500,000 per patient per year.
If you took that cheapest one, it's about $10,000 per patient per month. That same product is retailing in other territories, such as Europe, for just over $8,000 per patient per month. It gives you a context of actually an orphan drug. The pricing is relatively uniform around the world as well. Now, just bringing you to the commercial partners that we have, it is strategic on how we have partnered at this time and bringing in that expertise with our key partners. We've got four excellent partners around the world now, bringing their expertise, particularly in their territories, for the regulatory, for the pricing and reimbursement, and of course their existing infrastructure for sales and marketing.
On the basis that we are able to go for an earlier marketing approval, it's really important that we have those in place so we can hit the ground running with logistics, distribution, and ultimately potential sales. The four marketing partners we have across the U.S , Europe, Canada, Australia, New Zealand, Middle East, and Japan. Across all of those, the total deal value is up to $1.4 billion. What's really important here is we've had over $65 million come in the door already before we've even got any further. That then shares the risk with our partners, but helps de-risk it from our investors. That is also really important in driving this product through to completion. Just talking to the corporate position at the moment, at the last quarter, June quarter, we had almost $70 million in cash.
That is sufficient for us to continue to drive our phase three clinical trial, but it also means we're now turning our attention to what else we may be able to work on and bring into the pipeline as well, given we do have a platform technology and there's a lot of opportunity out there for us to work on other orphan or kidney products. That just gives you a context of the full company opportunity at the moment. Put that into the catalysts for 2025. We've already seen in quarter one, quarter two, us hit a number of those milestones that we aimed to achieve in those quarters. We expect in quarter three, quarter four, a number of different activities. The first one, of course, is the outcome from that Parasol opportunity, the FDA feedback, as well as that blinded interim analysis towards the end of the year.
We also expect to hit full recruitment by the end of the year, but also introduce those additional pipeline opportunities. The other thing just to put into context is the potential upside that can happen at any time, as we've demonstrated with the four licensing deals we've done to date. That is the opportunity for all of those other territories for licensing, including China, Latin America, and other available territories as well. There's a big opportunity for commercial partnering that could come in at any time as well. Thank you again for listening today. This is an opportunity to give you a broad snapshot of the clinical trial. I do encourage you to look at the full slide deck with additional information and look forward to updating the market in due course. Thank you.