My name is Claus Elsborg Olesen, and while I'm waiting for the clicker, I'm the CEO of Initiator Pharma. At Initiator Pharma, we are developing clinical drugs for sexual dysfunctions and pain. Of course, just hearing the speak now, that will be something that will probably be difficult to do in the U.S. at this time. We are advancing a pipeline of drugs that modulate monoamines. Monoamines are signal molecules in the brain that control a lot of behaviors, such as sexual function, mood, also involved in locomotive function, and also in memory. We have two clinical assets, pudofencin, that we are advancing in organic erectile dysfunction, where we have phase two data showing that we can treat moderate to severe ED patients. Is this going in and out?
We have shown in a pre-clinical, sorry, in a phase I pain challenge study that we actually have good effect in neuropathic pain, and also that we have pre-clinical data showing that we have good effect in female sexual dysfunction. That drug candidate is what I'll talk about today and also highlight what we are now doing with this pain profile of this compound. The program librafem is something that originates back to that pudafensine has a really good pain relief profile that we demonstrated in a healthy volunteer study. Also, because we know that vulvodynia, which I'll come into, also patients suffering from this experience sexual dysfunctions. We see a good combination of harnessing two of the benefits of pudafensine in this program. What is vulvodynia? Do you know vulvodynia? Anybody in the audience knows? There's a few hands.
It's actually surprising because you can say it's actually a relentless pain indication. About 10% of all women are suffering from pain in the vulva. If you look at this, looking in the U.S. and across Europe, it's more than 30 million women daily living with very severe pain that doesn't allow them to walk, bike without hurting, and not even having a sexual intercourse would hurt even more. What's really interesting about this indication is that there's no approved therapies out there. We don't know how to treat these patients. Often we try to mix many different painkillers, but nothing has been shown to demonstrate any efficacy in this indication. What we are doing with our compound, pudofencin, actually, we want to go in and we want to demonstrate that we actually have an efficacy on vulvodynia.
Vulvodynia, for many, is representing as a localized pain. Actually, it's been proven in 2005 by Dr. Foster that the pain sensitization in vulvodynia patients goes through the central nervous system. When you want to target this, you cannot just have a local peripheral acting cream to give pain relief. You actually need to do something that changes the pain perception in the brain. This is exactly what we can do with pudafensine. Our mission right now is actually to go out there and show that pudafensine can provide pain relief for the women suffering from vulvodynia. Similar pain that we have shown in the healthy volunteer study that we can provide relief. I'll show you a little bit on the study.
There is a number here on states, and that's from 2014, saying that the overall economic burden of this is about EUR 61 billion in 2014 in the U.S. alone. This is not only a women's health issue. This is actually an issue for the whole society that we need to do something about. On the left hand is the science. What we do, we modulate the monoamines in the brain. I will not talk so much about that, but actually by increasing the dopamine component of the brain, we can provide pain relief. This has been done before with other compounds, but our compound is very safe. We don't see any of the side effects that are normally associated with modulating monoamines. This is because we primarily target the dopamine transporter.
What we also have demonstrated already is that on sexual dysfunction in men, which is also the same mechanism driving sexual function in women, we actually got really good pain relief. We have shown in a phase I pain challenge study that we provide really good pain relief in allodynia, which is oversensitization, which also is what we see in the vulva of these patients. What we will do, as I said in the beginning, we will actually exploit these two properties to develop a first-in-class treatment for women suffering from vulvodynia. There is no other compound that has targeted dopamine the way we do before with that safety margin that we are demonstrating. Just coming looking in, what are we going to do in this clinical trial that we just received an approval for from the MHRA, which is the authorities in the U.K.?
We'll do what we call a randomized double-blinded placebo-controlled study in a four-way crossover. That means that we will take 24 women that will come into the clinic, and first we will assess them for what kind of pain they have. We'll use something called the tampon test, which is just like it sounds. It's a tampon you insert and you retract, and then you score how much pain does this provoke. They need to have a threshold of minimum four here. The patients come in. They will go to the clinic four times where they will receive a single dose of either pudofencin at high, medium, or low dose or placebo, not knowing what they're getting. After the dosing of the compound, we'll conduct a couple of tests. The primary endpoint is what we call the Wagner Algometer.
It looks a little bit like a pencil that you push against the vulva, and then when the patient says that it hurts or they click the button on the release they have in their hand, it actually reads out how many newton- meters could be applied pressure to the vulva in different places. As soon as we have those numbers, it does not hurt for the patients anymore. They can go back to the ward and we can measure two hours later. At the end of the testing day, we will include our secondary endpoint, which is another tampon test. They will do that again just like we did in the inclusion. In the tampon test again, we can only do that once a day because that interferes a little bit with the vagina and also with the mucosa and so on of the vagina.
That is why we only do this test once a day. There will be follow-up questions after they're being sent home. How long does this pain relief help you when you're administering pudafensine and that you see some benefits on other measures such as walking, biking, or sexual intercourses? This is the study we're going to do. As I said, we got an approval for this last week, last Monday. We are set to start this study and we are enrolling patients as we speak. The study is financed in something that's a little bit different from a lot of companies out there. What we actually did when we did this study, of course, the study itself is about GBP 2.5 million in direct costs.
Actually, the CRO that we worked with for many years actually decided that they would invest in this trial. They are paying for the direct costs of the trial. They will convert it into shares when they have finalized the study and they've given us the final report. At the time of the deal, they agreed to pay a 40% premium to the TERP. They will give you a premium pricing. Instead of giving a discount to raise money, we actually got a premium to converting this in. At the same time, we did a rights issue to be able to pay for our own costs and also pass-through costs such as data monitoring, databases, and so on. With that financing, we are financed into 2027 and we expect the clinical trial to read out in end of 2026.
We have good time after the readout of the study to make a deal. Just looking at the value of this market and with the number of patients that are suffering from vulvodynia, this is, of course, a huge opportunity. We actually did a very conservative estimate here. We reduced the overall number of patients in Europe slightly. We looked at very conservative drug prices both in Europe and in the U.S. With a market penetration of 10%, we actually see sales potentials in peak sales would be above the combined EUR 3.5 billion. The pricing in the U.S. is below the pricing that is currently marketed for hot flashes medication for menopausal women, about half the price of that. We think that this is a fair assumption and just shows you that the potential is huge here.
Of course, coming into this market, we'll be marketing creating because we are the first treatment out there for these patients. There's many companies and some of them will be represented here today in the Women's Health Panel. I'm very excited to see that there's a growing interest in women's health. We, of course, we are in dialogue with all these companies that have programs within women's health. What we actually hear from a lot of them is they want to see phase two data that we actually can provide efficacy in patients. That's exactly what we are set out to do. Just on the team briefly, the team behind it, the operational team, I would like to take Michael on the left-hand side of the slide, has a background as a Head of Global Clinical Pharmacology at Novo Nordisk and been running multiple trials.
He's the mastermind of running these trials. A lot of times you can just outsource a trial and hope for the results to get in and everything runs according to plan. Michael is on the phone one, two, three, four times a week, making sure that everything is running according to plan. We get to see all patients that are enrolled in inclusion criteria together with Ulf Simonsen. We make sure that we get the best quality trial that we can get by monitoring this closely. On the business development side, we have a very strong focus on finding either regional or global partnerships taking this forward. You can see the key value drivers for these partnerships that we are talking about here is the neuropathic pain program, vulvodynia.
We also see with actually this is an opioid alternative, so it's a non-opioid we are developing. There's good life cycle management in other neuropathic pain indication conditions, and we see good interest in that. Also in the erectile dysfunction where we have demonstrated phase II data as a monotherapy, there's good pre-clinical data on combination with the PDE5 inhibitor with strong patent protection. Finally, we have shown in pre-clinical models that this would work in female sexual dysfunction, but I will come back to that. As the very last slide, we are dedicated to develop medication that actually changes the future of healthier lives.
A couple of questions here. Yeah, you very kindly plugged the Women's Health Panels. Thank you for that. I wanted to ask you, considering then that women's health has been underprioritized and underfunded for a long time, what kind of reactions have you had from the medical profession when you bring them this, your solution?
You can say that a lot of the pharma companies that are interested in pain and also in women's health, they know, of course, about the indication, but it's not as known as endometriosis, for example, right? This is the same size of population you're looking at. Of course, we need to do a lot of marketing trying to promote this. Some of these indications, endometriosis and vulvodynia, of course, are really big indications. The patients are diverse. Of course, and that can always say when you don't know how the patients are looking, you think it's a challenge. Challenge is what we like, right? We want to find something that's difficult to do because we also know then it's meaningful to change the life of these patients.
As a final question, the biotech market is still quite challenging. I think we all know that. What's your, if you could just elaborate on the strategy for creating long-term value and attracting partners?
Yeah, you can say that initially that we always had the ambition, we want to do things right. What I mean right is we want to conduct proper clinical trials where we have placebo-controlled. We make sure we look for clinically relevant endpoints. We do the studies in the right way. This we can see when we go and speak to pharma. This is highly appreciated. They appreciate the quality of our trials. Of course, it is a tough market. There's less bias out there, but we now see a little bit of a change in this. Also, we can definitely see that where men's health and erectile dysfunction was maybe a limited number of companies, we now see with the pain addition to it and also the women's health angle, we see a lot of strong incentive for going forward.
There is actually more, not interest, but maybe more incentive to do the women's health, not to, we should not, it's not a competition between the two conditions, but it's an interesting observation.
Yeah, I think for us, it's, you know, if you want to have the best possible deal, you want to have more buyers, and actually by bringing in the pain program and women's health, it's bringing more potential buyers to the table.
Thank you so much, Claus.
Thank you very much.