Good morning or good afternoon all, and welcome to the Moberg Pharma Conference Call. My name is Adam, and I'll be your operator today. If you'd like to ask a question in the Q&A portion of today's call, please press star followed by one on your telephone keypad. I'll now hand the call to Anna Ljung to begin, so Anna, please go ahead when you are ready.
Thank you, and welcome everyone to this telephone conference following the press release yesterday evening. Please note that this call will be recorded and will be made available on our webpage. With me today, I have our Chief Medical Officer, Anders Bröijersén , and our Chief Scientific Officer, Amir Tavakkol. Today, we will provide an important update on our ongoing efforts related to our product MOB-015. We understand that there is a significant interest in the progress of this program, and we aim to be as clear, transparent, and forthcoming as possible. Our objective is to address not only top-line results from our North American phase III study, but also preliminary strategic implications that arise from the data. However, I want to emphasize that this is top-line data that we have just received, and both we and our partners need time to thoroughly analyze and digest the information before making conclusions.
I will begin with an overview of the study, key results, and our reflections on what these results mean for our business strategy going forward. After that, we will open up the floor for questions. So turning to that overview of the study, the North American study was conducted at 33 study centers across the U.S. and Canada, including a total of 384 patients. Two-thirds of the patients received MOB-015, while the remaining third received a vehicle. To maintain consistency, we deliberately kept key elements of the trial the same as in our previous studies. This included using the same investigators, CRO and mycology lab, while also providing comprehensive training to ensure good compliance. This study differs from previous studies with MOB-015 by reducing the dosage to eight weeks of daily dosing, followed by a weekly maintenance treatment for 40 weeks.
The previous studies, which are the basis for drug approval in 13 EU countries, had a daily dosing throughout the entire treatment period. Our goal was to evaluate whether this dosing adjustment could deliver comparable or better efficacy while offering the advantage of less frequent dosing. A few words on the selected dose regimen. Our formulation and dosing regimen worked well in previous studies, and it is reflected in our European approvals. However, given the very high mycological cure rate seen in the previous studies, we also expected better clinical outcomes. We believe the results of the previous studies were confounded because of whitening and overhydration of the nail plates, our effective formulation. This interfered with the investigator assessment of the nail and likely clinical cure process and nail appearance. Already at week 12 in the previous studies, 70% of patients showed tracks of whitening and overhydration.
The current phase III was therefore designed to reduce the frequency of application and dosing through eight weeks of daily dosing, like a loading dose, to allow fungal killing, followed by once-per-week dosing to avoid nail overhydration and whitening effects, while at the same time maintaining fungal eradication. It is a combination of parameters that led to the exact dosing in the study, including analysis of patient photos by key opinion leaders from our previously completed phase III trials with the first visits at week 12, photos from earlier time points such as four and eight weeks from vehicle data, and mycology data at different time points, and also the biopsies at 24 weeks showing a concentration of terbinafine with daily treatment that is 40x higher in the nail bed to what is known levels with oral treatment.
So in line with previous communication on September 13, the results now confirmed that the primary endpoint was not met. The primary endpoint, defined as the proportion of patients achieving a complete cure of their target toenail at 52 weeks, was achieved by 1.5% of patients receiving MOB-015. No patients in the vehicle group achieved complete cure. It is important to note that complete cure is a composite endpoint requiring both a completely clear nail and mycological cure. For the key secondary endpoints, the results were as follows. For mycological cure, we achieved 25% of patients receiving MOB-015. Treatment success, as assessed by the investigator, was achieved in 11% of patients. Regarding nail whitening, while not a formal endpoint, we did see an improvement compared to earlier studies.
Previously, about 70% of patients showed whitening at 12 weeks, according to key opinion leaders' review of photos in both studies, as well as looking at the number of nails scored as increased affected nail area by investigators at 12 weeks versus baseline. We have just received the data, so no formal review of all photos has taken place by external key opinion leaders. However, our internal experts had reviewed the data and also shared some of the pictures with key opinion leaders. As expected, whitening seems less frequent at 12 weeks compared to the previous studies, also indicated by assessed affected nail area by investigators, where 49% of patients were scored as having a worsening, so increased affected nail area by investigators at 12 weeks versus baseline. Corresponding number for eight weeks was 54%.
Thus, comparing to previous study with about 70% at 12 weeks, this indicates that fewer patients develop whitening with the new dosing and that the whitening seen at week eight is reduced by switching to weekly treatment. Turning to the mycological data, mycological cure was 25% after 52 weeks and only achieving 16% at 12 weeks. This is way lower than the numbers seen in our previous studies, starting at 37% to 47% at 12 weeks and gradually increasing to 76%. The difference between the groups at 12 weeks is that instead of getting daily dosing for the full 12 weeks, patients in the new study got eight weeks of daily dosing followed by four weeks of weekly dosing.
The drop in mycological cure indicates that eight weeks of daily treatment is insufficient to kill off the fungus, and while we see some improvement of mycological cure throughout treatment, levels remain low and show that although weekly treatment may be sufficient to prevent reinfection, we were unsuccessful in killing off the fungus to start off with. Whether another longer daily treatment period might have been helpful is impossible to tell. Unfortunately, the only way to know is to conduct lengthy and expensive clinical trials as patients need to be followed until healthy nail regrows. We still believe that there is a balance between delivering sufficient drug and avoiding the hydration whitening effect on the nail, where there is an interference between this whitening effect of the nail and the clinical cure assessment. We have managed to reduce whitening, but at the expense of not supplying sufficient amounts of drug.
The patent application builds on the hypothesis that new lower dose would result in a higher complete cure rate. Unfortunately, the data from the study does not support this, so new data has to be generated for the patent application. We also have granted patent protection until 2032. Following these data, we and our partners will further analyze the results and determine the best way forward. Given that the study did not meet its primary endpoint, we do not have the data package required to file for regulatory approval in the U.S., as FDA typically requires two successful superiority studies. We have also investigated the possibilities of taking an OTC route in the U.S. Provided that the data supports Rx approval, an OTC route for a topical onychomycosis product in the U.S. is possible, but takes time.
We have no immediate plans to do another U.S. study with the original dosing or another dosing given the timeline and costs involved, and our original strategy was to combine direct sales in the U.S. with strategic partnerships in other key territories. In light of the top-line data, we are reassessing our plans for the U.S. and shifting our primary focus to Europe, where the regulatory approvals are already in place and where we see the greatest opportunity for growth. During this late autumn, Bayer has conducted an extensive review of its pipeline, and we have together decided not to continue the collaboration due to strategic reasons and the top-line data received, so therefore, we have expressed a mutual intent to terminate the license agreement, whereby we regain the full rights in EU and retain milestone revenues already paid by Bayer.
For Moberg Pharma, this represents both a challenge and an opportunity. We remain confident in the competitive profile of MOB-015, as seen in the successful launch in Sweden. By regaining control of MOB-015 in Europe, Moberg Pharma can secure a larger share of the value chain and play a more active role in commercialization. This includes brand ownership and better margins. Following the subset of data communicated in September, we have been working with multiple scenarios, including a shift in focus towards EU being the greatest opportunity. Moberg Pharma is now in discussions with potential partners in Europe to identify an optimal path forward. Our intention is to update you once our business plans have been detailed and negotiations have progressed. We see great opportunities in Terclara for the 13 approved countries in EU, and with more to come.
Terclara is already the market leader in Sweden and has grown the market by 44%. Having a 76% mycological cure, daily dosing is outstanding for topical onychomycosis drugs, and the success in Sweden confirms that the marketing message and claims of the product resonate well with consumers. I'm looking forward to updating you on our plans and progress forward taking Terclara to market. In summary, the North American phase III study for MOB-015 did not meet its primary endpoint, and its mycological cure rates were lower than those seen in previous studies. The reduced dosing regimen decreased nail whitening, but came at the cost of lower mycological cure. The strategic implications of these results are significant. The findings confirm that sustained daily dosing over a longer period, as approved in EU, is essential for effective treatment.
As a result, Moberg Pharma will shift its commercial focus away from the U.S. and towards Europe, where the original dosing regimen is already approved. Plans for direct sales in the U.S. have been put on hold as FDA requires two successful superiority studies for regulatory approval, and the current study failed to meet its primary endpoint. A key development arising from the data is our shared decision, together with Bayer, to stop the collaboration due to strategic considerations and top-line results. As a result, we will regain full rights to MOB-015 in Europe while retaining milestone payments previously made by Bayer. This is also an opportunity to capture more of the value chain in Europe by taking a more active role in commercialization and brand ownership. Discussions have been initiated with potential partners in Europe to support this strategy.
Our approved E.U. product, marketed as Terclara, provides a strong market opportunity. Terclara has already become the market leader in Sweden, with the product achieving 76% mycological cure under the daily dosing regimen. We plan to use Terclara as a star brand in Europe with the potential to expand to more E.U. markets. The strategy may include acquisitions of complementary brands to create a broader product portfolio, similar to what was previously achieved in the U.S. market. And with that, I open up for questions.
As a reminder, if you'd like to ask a question on today's call, please press star followed by one on your telephone keypad now to enter the queue. When preparing to ask your question, please ensure your headset is fully plugged in and unmuted locally. That's star followed by one on your telephone keypad. And our first question comes from Dakota Quince.
Dakota, your line is open. Please go ahead.
Hi, Anna, and thanks for taking the call. So obviously, you weren't getting the label outcomes you were looking for with this trial. You were able to reduce the whitening, and this is kind of a question for at least Amir or Anders. Reading about terbinafine, well, ergosterol deficiency, it weakens the cell membranes. And consideration for past things Amir has said about excess hydration that was unrelated to that composition, I'm wondering if that whitening is cell death. I know it's preliminary, and unfortunately, that would just be something that you're just getting punished for having a good topical that works well because it's causing all this excess cell death to occur continuously with continued application.
And just in the spirit of market access and what we've seen of the good work we've seen Allderma do with capturing all of that market, I'm just wondering if they could take if that would be sort of your ideal partner of choice for Europe. And I would be interested in hearing back if there's any validity to that possibility from the key opinion leaders like Amir. And yes, thank you.
So if I start with a question that I believe was directed towards me, whether Allderma would be our partner of choice, I would say that we have dialogues with several partners, and we aim to get back to you as soon as we have clarity on the road forward. But we definitely see a road forward where we control a larger share of the value chain, but we won't do it all by ourselves.
We will definitely have a partner involved in the conversation going forward. And Amir, perhaps you want to address that other question?
Yes, Amir Tavakkul here . I just hope I understood the question. I think you are correct in the fact that terbinafine obviously inhibits the enzyme squalene epoxidase and further downstream inhibiting production of ergosterol, which is a cholesterol required for membrane assembly. I think this is pretty specific to antifungals, in this case, terbinafine. I'm not really quite sure the vehicle would have such a kind of potent biological activity to inhibit cholesterol production or lanosterol production. Is that what you're asking?
Well, it's just your MOB-015 gets a lot of terbinafine into the nail plate and the nail bed, way more than systemic oral therapy, and it does so very quickly, which is what's been observed in the past.
So I'm just wondering if it's possible this excess hydration you've referred to in the past could be cell death. And if that's the case, well, I mean, Moberg Pharma is just being punished for having a nail topical that works really quickly. I know it's really preliminary, and the data was just unblinded 12 hours ago. But I was just curious to hear your thoughts on that idea, just because it's an oddity for sure.
Right. No, I hear you. So yeah, so I'm really doubtful that that is the case. As you know very well, the live or viable fungus resides underneath the nail plate, in the nail bed. That's actually where the site of infection is, which often kind of goes unnoticed. So the discoloration or the whitening that we see is really very superficial, is limited to the nail plate.
Given the formulation, which is, as you know, again, contains amount of urea, lactic acid, and propylene glycol, these are really known moisturizers, known hydration kind of excipients, and they're used widely in industry. So my belief is that it's really just a superficial effect. I don't really think that it is an overdosing and killing the cells. These are keratin. They're dead on the surface, and I don't think it would really affect the viable fungus, which is way underneath the nail plate in these kind of spaces. But it is an interesting idea.
Yeah. I was just thinking about the excess hydration you referred to in the past because you said it doesn't come from the composition, to my understanding. So I was curious about that. But okay, thank you. I appreciate you.
No, actually, it does come. I'm sorry. Maybe we misspoke.
I doubt, but it really actually the cause of hydration, overhydration, is the excipients because we see the same, if you like, phenomena in both vehicle treated as well as MOB-015 treated. So that is explicitly because of the excipients. As Anna just nicely alluded to, by lowering the frequency of dosing, we reduce the hydration whitening, but then that came at the expense of delivering less dose of the active drug. But they are still very closely linked.
Gotcha. Okay. Thank you for your time. Congratulations to Allderma. Allderma, you knocked it out of the park with that launch, and you deserve everything that's coming because they earned their stripes for that launch. This is just me hoping, Anna, but you should give them more of Europe if you can. Okay. Thank you.
Thank you. We're really pleased with the collaboration with Allderma, of course.
The next question comes from Johan Holmström. Johan, your line is open. Please go ahead.
Hello. My name is Johan Holmström from Sweden. I'm a private shareholder. You earlier announced that around this time of year, you will announce a new supplier of terbinafine. I wonder how is that proceeding? That is my first question. And then, as a shareholder, I'm interested to know more about the business plan and the rollout in Europe. When do you expect to enter the first country, and what will the situation be in 12 months, 24 months, and 36 months if you can give us some kind of information about that? Thank you.
Sure. So if we start with the terbinafine question, so as we announced in the quarterly report, we have answered the questions from the Swedish MPA regarding the application, and we are waiting for the agency's decision.
We have no new information, but we really do expect approval shortly. And of course, the terbinafine supply, that's also linked to the rollout plans because we need that terbinafine supply to be in place in order for us to roll out in more countries. As I said, we think it's around the corner, but we're awaiting the approval by MPA. And I would say that the timeline of the rollout is not really affected by this decision. Our goal remains that we will launch in the approved countries in 2026. So it's not really a change of plan when it comes to that. When it comes to the details around the launch in every country, well, now we have ongoing discussions with potential partners, and we need to get that in place and come back to you with an updated business plan.
Okay. Thank you. May I ask you, when you talk about 2026, why are we talking about 12-24 months from now? Why does it need to take so long time to do the first launch in the first country outside Sweden?
Yeah. So the reason for that is that we don't have approved drug substance to the extent that we need in order to launch in more countries. So we need that approval. And just assume that we will get that tomorrow, then that's excellent. But that approval, then you need to produce the drug. And more importantly, the pharmacy chains need to put the drug on their shelves. And unfortunately, there are typically windows when they accept new drugs. So if we take our Swedish launch as an example, there are basically three windows in Sweden when you can enter a drug into the shelves.
It's February, it's March, and it's October. When we entered in February last year, then that decision was made by these chains in August and September the year before. The timelines for the decisions for the chains, that's really the critical time point here. We want to enter at high season. The reason for that is not so much that we want good sales to start off with, but we want to be part of the chains' campaigns. They only have the campaigns while at high season. They typically have a foot campaign following the high season. That's super important in order for us to actually enter all the chains at the same time. We were successful in Sweden, so we now have coverage on every pharmacy chain in Sweden.
If we're going to spend money on advertising, of course, it's crucial that the pharmacies have the product on the shelves. So entering at peak season is critical, I would say, for us to do a really good launch so that we get acceptance by the chains, so they will take in the product ahead of the peak seasons, and then we will do combined marketing with the chains over this peak season. So that explains the timeline, I hope.
Okay. That's good information. Thank you. May I ask another question?
Sure.
What I read also is that you have increased the market in Sweden with 40% since you launched the product, which is an amazing feature. May I ask you, what size is it on these 13 countries where you have approval of the market in euro, so to say?
Can you give us an approximate number of that?
I would prefer not to because I think they're really different, the different markets. They, of course, have similarities, but I think that I'll rather come back to that when we have a thorough analysis of exactly how we will approach each market. Because even if we say that our goal is to take a larger market share ourselves, I don't expect that we can do that in every territory. So margins and so on will vary between countries. The structure of these countries are rather different. So in Italy, it's really down to covering the different pharmacies, and it's very, very local, requires a lot of foot on the ground, but it's a really interesting market. Whereas you have the chain-based, the pharmacy chain-based markets in Northern Europe.
So Europe is rather well, it's 13 different markets, and they all look slightly differently. And we think we will have different market share in these different markets, and we have different views on to what extent we can grow these markets, how mature they are. But we do think that this product has the capability to become the market leader in each of these 13 countries. So that's really our goal.
Okay. Thank you so much for good information, Anna.
Thank you.
The next question comes from Dan Carroll. Dan, your line is open. Please go ahead.
Hi. Thanks very much for taking the call. So a couple of questions. I'm very excited to hear that the European launch timeline has not been affected. That's wonderful news.
I was just wondering if you could talk to, given the change in situation with Bayer, whether you regard yourself as being fully funded to pursue that rollout as you think about it today and that you're sufficiently capitalized for that. The second thing I would like to explore a little bit is the conversation around the U.S. market. I think you said that there was no immediate plan to run another phase three trial, but that there might be the possibility of going OTC. I'm wondering that would probably require a different concentration of terbinafine and whether such a trial might be put in place or what the approval process might be or whether you're just thinking about putting such trials off for a few years until Europe is rolled out. So those would be my questions.
Okay. So if I start off with the U.S. question, so right now, we have investigated the possibilities of taking an OTC route, and we have also investigated the monograph route and concluded that monograph route is not possible. But the OTC route might be possible. And the challenge with OTC route is that today, there is no onychomycosis drug that is approved OTC in the U.S. today. So the drugs that you find on the shelf in the pharmacies, they're not really for onychomycosis. They're for athlete's foot and so on. And they're labeled in a way so you might think that it's for onychomycosis, but it's not. So for me, it was important to understand if this is doable or not. And we think it is doable. It takes quite some time. It's a three-to-five-year exercise.
Of course, there is a price tag associated with it as well. I think that the key question in the U.S., regardless if it's Rx or OTC, we need the FDA to approve our clinical data. Basically, what we hear is that you need to have two studies showing superiority. Today, we only have one study showing superiority. If we are to proceed in the U.S., the conclusion is that we need to conduct one additional study. Given the time and cost associated with that, I think for the time being, we're focusing our efforts on Europe. We'll get back to you with detailed plans, but I would rather spend the excess cash that we have in the company on making sure that Europe is a great success. I think it makes much more sense. You also asked about the financial situation.
As could be seen in our quarterly report, we have slightly more than SEK 300 million in cash in the company. We do have some excess cash that could be invested both, I would say, in a direct-to-market approach in Europe and also potentially to acquire additional brands that would be a good fit together with MOB-015 or Terclara. We have no plans for raising additional funds as of now. We're well capitalized. I'm looking forward for things to materialize so that we can talk about these potential partnerships, that partnership discussions that we have ongoing, and present the full business case.
Thank you very much. I appreciate that comment. It's exciting to hear that there's certainly no likelihood in the near term of a dilution and that you're fully funded for the European rollout, which remains on track. One last question.
I didn't understand the comment from earlier in the call about whether or not it would be possible to rerun a U.S. trial if you chose to do so. Obviously, the timing is a different question. But just to rerun with the original label on a daily basis, if you could replicate the results of the first study, that would be sufficient for the FDA. Is that true?
Well, it's challenging to know on beforehand if you do exactly the same study. Will you end up with exactly the same results? That you never know. But I'm just repeating myself. If we provide two studies showing superiority, then I think we have a very good material to present to the FDA. And then ultimately, it's the FDA's decision whether to approve a product or not on that data. But that is the data that we hear is needed for approval in the U.S.
Okay. But I'm just trying to understand the hypothetical. So if you were to rerun the same trial, probably it takes 18 months between recruiting and running the trial. And if you were to replicate the results of the first trial, there's no immediate reason to believe you wouldn't. That, in theory, would provide you with the sufficient data.
Yeah. But it is a four-year exercise and a significant cost, of course.
Well, thank you very much for taking the call. Very excited about the European rollout and look forward to hearing more from you. Thanks for taking my question.
Thank you.
As a reminder, that star followed by one on your telephone keypad now to ask the question. We have a question from Guido Tombardi from Traders' Partners. Guido, your line is open. Please go ahead.
Hello. Thanks for taking my questions. Question number one is about the strategy for the patent. I didn't really understand what the strategy is, if there is any. And the second one is about the other European markets. Now we got approval for 13, wondering if there will be more markets in Europe opening up, and what's the timeline for those? Thank you so much.
Thank you. I'm not sure I got the first question. Could you please repeat that one?
Yeah. What's the strategy in terms of patent extension? Is there anything planned to possibly obtain an extension to their current patent?
Okay. Yeah. So I'll start with the timeline for additional markets. We do have 13 countries that are approved, and we do have an open file.
We have the ambition to include more countries into the European file, and we could also potentially file in countries outside of the European Union, but that are looking at basically the same file. So U.K., for example, would be a good example. If we are to add more countries into the European file, which is our plan, but we have no fixed timeline for that. And the reason for us not having a fixed timeline is that we cannot have several variations in our file at the same time. So you really have to think about in the order to do things here. Right now, our highest priority is to get the new terbinafine supplier approved. So that's already an ongoing variation with our file. So while that's ongoing, we cannot add another market. And our plan was potentially to change the label somewhat coming out from this study.
That is probably not the case right now. But there might be other issues where we want to prioritize existing markets. For example, if we want to switch one or two of the Rx markets into OTC, that's also a consideration versus including new markets into the existing file. So I'm not going to tie myself to a certain timeline, but we will, of course, think very thoroughly about in what order we're doing this when it comes to the European file. And long term, there's definitely the goal to expand it to more countries. And then it was a patent question. Trying to remind myself. And the ongoing patent application, it builds on the hypothesis that lower dosing would result in higher complete cure rates. And the data from this study does not support that.
So we have to generate new data for this patent application to be able to be transformed into a valid patent. But we do have granted patents. So we do have granted patents until 2032. We don't see any possibilities to prolong those patents. So it is 2032. But of course, it's a priority for the company going forward to work with patent protection and, I think, equally important with brands. Because when we're talking about OTC markets, it's really the brands that build the majority of value, I would say. So going forward, I think it's a really important outcome of us getting the rights back is that we now control our own brand in Europe so we can build value long term, connecting to the Terclara brand.
Thanks for your answers.
The next question comes from [audio distortion] . Your line is now open. Please go ahead.
Hi, Anna. Thank you so much for this call. I wanted to ask a question about South Korea and Israel. They don't come up very often. I know these are smaller markets, but have you had conversations with those partners? Are they still on board? Anything that would need to be done from your file with the positive daily case studies that we did with the U.S. and Europe in those countries? Thank you.
Yeah. So as you know, we just got in the data. So of course, we are in dialogue with all our partners, but both we and our partners need time to digest the data. So it's simply too early. We have to get back to you while we and our partners have revisited the business case and have a route forward.
So I would expect that within our Q4 report, then we can give a good update to the market.
Thank you.
The next question comes from David Bryce. David, your line is open. Please go ahead.
Thank you very much, and thank you for taking my call. David Bryce, private investor from Denmark. And you alluded to, Anna, that you would be able to share a more detailed business plan in terms of the rollout in Europe. My first question is, when do you expect that business plan to be shared with our shareholders? The second question is just to remind us all what the market opportunity in Europe is, not so much what we expect to get in the European market, but more what is the broad opportunity that we're addressing here. Thank you.
Yeah. So when it comes to the timing of an updated business plan, it's not totally up to us, I would say, because as it says in the press release, we are in discussions with partners. And it's hard to get a fixed timeline, but obviously, we will inform the market as quickly as possible. And when it comes to the overall potential of the European market, I would actually go back to our old estimates on the market, the pricing of the market for MOB-015, where we previously had said that it's between SEK 35 million and SEK 50 million in annual sales potential for the product.
Thank you.
The next question comes from Fabian Bacchia. Fabian, your line is open. Please go ahead. Fabian, your line is open. Please ask your question. We will move on. The next question is a follow-up from Johan Holmström. Johan, your line is open. Please go ahead.
Thank you so much. When we talk about the strategy, I wonder, you're talking about having your own feet on the ground in some countries to push for sales. Have you used that strategy before? Is that something that you're familiar with, so to say?
Yeah. Perhaps, did I use the word feet on the ground? Maybe I did. So typically, we have never employed feet on the ground, and we have no intention to do so either. If we look back on what we were successful with in the U.S., was really that we were in charge of strategic marketing, and then we hired personnel to be feet on the ground as needed. We're thinking something similar here, but I think this was a couple of years ago, and we really see a development in many European countries.
So I think there will be much more digital focus and so on. We really see a trend in several European markets where the online pharmacists are taking a significant share of the market. So the environment is changing, and we're aiming to fit to the current environment and not the environment that we had in the U.S. with our previous product.
Okay. Thank you.
The next question is from Felix Lindbergh. Felix, your line is open. Please go ahead.
Hello. This is just a minor question. I could not read in the press release what was the mycological cure rate and the treatment success in the vehicle arm.
Yeah. So we only included the very top-line data, and all the data will be available via ClinicalTrials.gov when all the data is released.
But basically, also the vehicle arm was lower compared to our previous studies, and I think that's a reflection of our vehicle not really being flippable, but a vehicle, and a reflection of the lower dosing. Thank you. Can you comment on whether there was any statistical significance in the difference between the vehicle and the treatment arm for mycological cure and treatment success? Yes. So I think we included the P-values in the press release. So you have a good P-value both for treatment success and for mycological cure.
Thank you.
Nothing further in the queue. So as a final reminder, that star followed by one to ask a question today. We have a follow-up from [audio distortion] . Guido, your line is open. Please go ahead.
Anna, thank you so much. So one last question because I didn't fully understand.
So we did not meet primary endpoint in the U.S. study, but the P-value was basically successful for the mycological, and we had a complete cure above 1.5%. And I thought it's better than the zero from vehicles. So how come did not meet its primary goal? Thank you.
So the primary efficacy parameter that was complete cure, that was only achieved in 1.5% of the patients and none in the vehicle group. And that was not significant. But the key secondary endpoints, the mycological cure and treatment success, those both were. There was a significant difference between the groups to our advantage. And it's really the primary endpoint. We needed that to be significant in order to be able to use this study toward FDA.
I see. The 1.5% complete cure is not enough. It would need to be a little bit higher for that.
I do have some difficulties hearing you.
Correct?
You're breaking up a bit. Could you please repeat the question?
Yes. What I meant to say is the complete cure on the daily one is around 3%, and that one was significant, but this one at 1.5% is not significant, correct?
Yes, so in the daily trial with the previous U.S. trial, it was 4.5%, and that was significant versus vehicle that was zero in the previous trial. In the European trial, it was not a superiority study. It was designed as a non-inferiority study towards another pharmaceutical, so towards ciclopirox, so Penlac in the U.S., so we met the primary endpoint in both two previous phase threes that formed the basis of the approval in Europe with this very high mycological cure that now is an excellent way of promoting the product.
But in this study, the 1.5% was not good enough. And looking at the other parameters, so there was significant difference when it comes to mycological cure and treatment success as well. But if you look at the levels and compare between studies, I know you shouldn't compare between studies, but nevertheless, there is no doubt in my mind that we did not get the mycological cure that we saw in the previous studies. It's way lower. And as a consequence of that, it also meant that the complete cure became lower, and we did not meet the primary endpoint.
Understood. Thank you so much.
Thank you.
We have no further questions. So I'll hand the call back to Anna for some concluding remarks.
Thank you. And thank you all for calling in. The recordings of this call will be published at our web page shortly.
Thank you all, and have a good day.
This concludes today's call. Thank you very much for your attendance. You may now disconnect your lines.