Thank you so much, Cecilia. I am glad to be here and present Initiator Pharma, listed on the Nasdaq as well. My name is Annette Säfholm, and I come with close to 20 years experience in the life science industry. Most recently, I led a women's health company all the way from spin out of university to commercial approval in Europe and readiness for market. I am very glad to be here and present Initiator's innovative pipeline with clinical assets for women's health, sexual dysfunction, and pain.
I am joining the very experienced Initiator team led by Claus as CEO and as a next step in strengthening the operational and business development capacity and the women's health focus after the recent appointment of Kristina Östby Lloyd as new board member, bringing senior international pharma experience and strengthening the women's health focus, of course, showing the commitment Initiator has to this space. Kristina and Claus are, by the way, in London today participating in a panel on women's health, and that is why I had the opportunity to present to you here. The central element of the science behind what we do is modulating the monoamines in the brain. The monoamines regulate important functions such as emotions, memory, and our drug has a specific action on dopamine and regulation of pain, arousal, and sexual function in both men and women.
Monoamines modulation has been done before, but the existing products or treatments, they carry significant side effects when they have been tried in these indications, such as interaction with the cardiovascular system. The novel drug that Initiator is developing, pudafensine, has a novel mode of action, so it works in a much more selective way. As you can see in the picture to the left, it blocks the reuptake of dopamine, which means that you get an increased dopamine concentration exactly where it is effective, but only where dopamine is already released, which contributes to the precise efficacy and superior safety profile of this product. pudafensine has been advanced in two clinical programs, and the first one in erectile dysfunction. There, we have shown that pudafensine safely and effectively treat erectile dysfunction.
We are targeting patients that are non-responders to current standard of care, Viagra and Cialis here, which is about 35% of all the patients with erectile dysfunction. In the phase II-B clinical trial met the primary endpoint, included 130 patients, so we have strong data on both safety and efficacy in this indication. The second clinical trial that is ongoing with pudafensine is for vulvodynia, and I will focus more on this in the upcoming presentation, given that we have a near-term endpoint, by the end of this year with a clinical readout from the phase II-A trial. Initiator also has an ongoing preclinical program in female sexual dysfunction, which is a very hot topic in the women's health area.
Focusing on the vulvodynia, which is addressed in the Librafem program, which combines the two main benefits of pudafensine, the safety and the pain relief with the effect on the sexual dysfunction, which are both relevant in the vulvodynia treatment. Coming into vulvodynia, it is a chronic pain indication affecting approximately 8%-10% of all women, so very common and most likely widely under-diagnosed. That means that across Europe and the U.S., over 30 million women are affected. It is severely debilitating, with a vulvar pain provoked upon normal daily activities, like walking, biking, and having sexual intercourse is, for many of these women, not a possibility or could mean severe pain for several days afterwards. Thereby, it also has a huge effect on the impact on quality of life, assessed as the highest possible score by majority of patients, five out of five.
It also means a lot of stigma for these patients. For several of them, it has been associated with a history of having repeated fungal infections, which is an indication I have been working with for close to 10 years, so quite related. Even though it is so debilitating and so common, there are no drugs that are approved, and there is very limited development in the pipeline. Which of course also open up the possibility when you have a possibility like pudafensine to treat this with the first approval that could define the category. So we are, as I mentioned, having an ongoing clinical trial in vulvodynia, and several steps of evidence lies behind this study. First of all, we have preclinical data showing that pudafensine, our substance, works with pain relief via central mode of action, with the mode of action being operative in the brain.
Lead investigators in this field have shown that the central mode of action is what drives the pain in vulvodynia. So it's the same mechanism that we have shown in preclinical. We have confirmed that effect in a healthy volunteer study, including 24 patients in a very robust design with a randomized design, and shown exactly the same thing as was shown with the vulvodynia by the lead experts, that it is a central driven pain, and we can, with pudafensine, relieve the central acting pathway pain. Response. Building on this evidence, we are now having an ongoing proof of concept trial in vulvodynia, where 24 patients with provoked vulvodynia are recruited and having a duration of the symptoms of less than a year. They are randomized to four different treatments, three doses of pudafensine and a placebo, and of course, it's blinded for both patients and doctors.
After each of these dose, the pain is assessed and compared to before treatment. So it's a very robust design, where you have the patient as their own control. The primary endpoint is change in pain threshold measured via a device that measures the exact pressure you can apply to the vulvar area in different locations when the patient indicates that they feel pain, and once again, compared to their basal values. In a secondary endpoint, we are evaluating the pain score of the patients when inserting and withdrawing a tampon test. So both of these measures are aligned with the U.S. and the European guidelines. When they are back home again, the patient also will fill in a questionnaire on other measures, such as duration of the pain relief and how it affects the normal daily activities like walking, biking, sexual function.
The study recruitment is going nicely, or the study progress is going nicely, and we expect to present data by end of this year. We look forward to that. There are no approved products in vulvodynia, and that means that a novel treatment would define the market and come out to a market without competitors. We have estimated the market potential with a treatment in vulvodynia, together with an external party, Global Life Sciences. We use very conservative assumptions for this estimation, with a conservative estimate on prevalence and market share and penetration of less than 10%, and the pricing in the U.S. set at about half the current pricing of menopause treatments. Even though it was conservative assumptions, you can see that there is a significant market potential, with peak sales of over $4 billion estimated, forecasted, as combined for the major markets.
A significant potential for a treatment in vulvodynia. Before I wrap up, I would like to comment on the work that we are doing on the business development, where I will work together with Claus and the team in advancing our partner discussions for the key programs. Both the vulvodynia, of course, which is highly interesting for partnering with phase IIA data that are expected by the end of the year, and which also is related to life cycle management opportunities in pain, given that it is also a neuropathic pain condition.
We have the erectile dysfunction program, which I mentioned earlier, where we have phase IIB data from 130 patients showing the efficacy and the possibility to also combine it with the standard of care PDE5 inhibitors, where you have a potentiating effect together with these, and where we also have a strong patent protection for the combination. There is also a growing interest in the female sexual dysfunction area, where the mechanism on the biological side is shared with the erectile dysfunction program. Very interesting as well from a partner perspective. Finally, I would like to sum up what attracted me the most from being asked to join the Initiator team. First of all, they have pudafensine, a novel mode of action, which has superior safety profile and has been de-risked in 200 patients. Strong patent portfolio.
The very near term catalyst in the vulvodynia IIA data by the end of this year. Meeting significant unmet needs on untapped markets, both for erectile dysfunction, where you have a novel mode of action, which can be combined and potentiate the current standard of care and have a different target group with unresponders. The first-in-class possibility in vulvodynia, which to me, coming with a women's health background, is of course something truly unique to stand alone on the market. Interesting indications for partnering with a great data package and a strong IP portfolio. Thank you all. Do you have any questions in the room? We will start in the back this time.
Christopher, Life Science Invest. Thank you so much. Brilliant external focus on your presentation. Since you are working through the dopamine release and reuptake, is there any sort of problems with addiction or any sort of going down the line?
Yes, that has been a problem with other existing treatments. We have not seen any of those, and there are preclinical tests that you can do, and we have done them to look at the risk of having addiction problems, and we haven't seen any increased risk of addiction with our product because of this very precise efficacy. It's a very relevant question. In general, the existing treatments, the drawback with them, especially in these indications, is especially the safety aspect. That is where we come in with something very more precise and efficacious, where we have shown the safety in over 200 patients.
I think a lot of patients, if it's working, I think they would like to use it quite a lot.
Yeah. Vulvodynia, chronic pain. Indeed.
Just say yes.
Maybe I was unattentive. Is it a cream?
No, it's an oral tablet.
Why not a cream?
Because it is central acting, that is actually the real reason why we think that this is more efficacious than other products. Because the lead clinical researchers, I am talking about the vulvodynia here. So in vulvodynia, they have shown that the pain in vulvodynia, even though it could be sensed as a local pain in the vulva, it is driven by a central pathway, driving the pathway via the dopamine system. That is why you need to come in via a central mode of action as well. For erectile dysfunction and female sexual dysfunction, there may be possibilities to combine with PDE5 inhibitors. I have not really looked into the possibilities to combine with creams. They are available in different dosage forms.
There is a combination that is quite interesting, with the PDE5 inhibitors, because they work in very different modes of action, which potentiates each other. You can say that Initiator Pharma's drug, it initiates an erection, whereas the Cialis and Viagra can prolong it. So in preclinical data, which is published, they have shown a synergistic effect. That is something that is quite interesting also, from a life cycle management perspective for these products, because it is huge populations.
On the slide you mentioned other neuropathic problems.
Other neuropathic pain, because it is an alternative to opioids. So other neuropathic pain could be interesting as well, since this is a first readout in the pain population after the health volunteer study that we previously did.
Which one are you thinking of first in line of other neuropathic pains?
I think there is quite an interest in several indications. I cannot mention any particular that we are focusing on because, that would be a later business development opportunity.
Thank you so much, Annette. Thank you. Very good presentation. Nice to hear.
Excuse me. One more question. I have one more question.
Sure.
That is, what about the risk of inducing a psychotic event?
I cannot really comment on that psychotic.
Yeah. Since high dopamine levels in the.
We haven't seen any of such side effects. They are quite common with other monoamine regulators, but we haven't seen any of such side effects in the 200 patients that we have studied.
Okay. Thanks.
Thank you.