My name is Jeremiah Lawrence. I'm one of the Equity Research Analysts here at Bank of America. It's my pleasure to introduce our next presenting company, Pharvaris. Today we'll be joined by CEO Berndt Modig. Berndt, take it away.
Yeah, thank you. Welcome, good morning to Pharvaris. To show you a brief presentation, it's only 15 minutes. If you have questions or want to follow up, I invite you to reach out to us, either through us here or over the website on the IR contact. I will be making some forward-looking statements, and I also refer you to our SEC filings also available on our website. Pharvaris is a company that is focusing on Bradykinin-mediated angioedema. As it says, they're pioneering science for patient choice. What we mean by that is the choice of the therapy, how to best treat an indication in Bradykinin-mediated angioedema. HAE is one form of Bradykinin-mediated angioedema.
We have two late-stage programs at the moment in phase 3 with our molecule Deucrictibant, which is differentiated in the sense that it has also both Prophylaxis and on-demand treatment. HAE is Bradykinin-mediated angioedema. It's a large global market. It's predicted to grow to about $5.2 billion in the next few years into 2036. It's also a very dynamic market. I've seen several new products over the last couple of decades. What we have seen is that there's still a large unmet need, and I'll talk more about that later, for people living with HAE. What we've also seen is that there's no real sustainable first-mover advantage for any new entrant. It's always the next step to fulfill an unmet need in the space. We have strong fundamentals, so well-funded.
I should say, the team in our R&D team and our commercial team, more than half of our people have prior experience in this therapeutic area. Hereditary angioedema is a genetic condition. It's a significant burden and impacts the quality of life. It's associated with unpredictable attacks of swelling in the deeper layers of the skin and the mucous membranes. These attacks occur very unpredictably and can happen anytime. They mostly affect limbs and hands and face, but can also affect upper respiratory airways and intestinal GI areas. The upper airway attack is always considered potentially life-threatening. The prevalence is about 1-30,000 to 1-80,000 individuals globally. You see here on the slide here that there are some pictures of a patient with this experiencing an episode of an attack. The quality of life impact is very significant.
An untreated attack takes about five days or so to resolve on its own. It is a reversible condition, but it has a big impact. The histogram here you see on the chart, you see the attack frequency. Most patients have around 12-24 attacks per year. Some patients have many more. This also is one of the factors that determines how a patient will treat HAE, either prophylactically preventing attacks or acute on-demand to treat an attack when it occurs. Deucrictibant, which is our molecule, is a B2 receptor antagonist. It is the same mode of action as another therapy that some of our members of our team were involved in developing in a prior company, Icatibant. It is a new chemical entity. It is a small molecule orally available. To our knowledge, the first and only small molecule orally available B2 receptor antagonist.
We developed Deucrictibant in two different products. One for prevention, which you see here on the green chart to the left, and one for treating acute attacks in an Immediate release capsule. The properties of the molecule, because of its longer half-life, also make it suitable for both of these types of formulations. These charts represent the PK profile of the two different formulations. We're using the same drug and the same active ingredient. As I said, we're the only company that really has that with the same drug for two different products to treat acutely or prophylactically. The exposure levels that you want to achieve in the plasma concentration is above the red dotted line that you see here. It's the EC85 effective line, which in the case of Deucrictibant is about 13.8 ng/ml.
The goal is to maintain exposure above this threshold level. In the case of the extended release formulation, you see that they have staying coverage over exposure over 24 hours from day one. The onset is slower than the acute formulation, but within a few hours, you have coverage. It also reaches steady state in a few days. On the IR side, you see the capsule. It has a very fast uptake, which makes it designed and suitable for treating acutely. Also, because of the half-life, a sustained coverage and exposure to ensure that the attack can be resolved effectively. This is our pipeline. In HAE, we have two phase 3 studies, as I mentioned, the RAPIDe-3 in on-demand and CHAPTER-3 in Prophylaxis. These are ongoing. We also have in parallel open-label studies that are also ongoing.
We have the top-line data is expected for the on-demand study, and we've guided to Q1 2026. For the prophylactic trial, the top-line data is guided to the second half of 2026. The dark blue part here is another form of angioedema called Acquired angioedema. It's not caused by genetic mutation, but it has the same signs and symptoms and the same clinical manifestations as they're similar to HAE. We are currently working in plan with also with the regulators to start a study for Acquired angioedema at the end of this year using Deucrictibant. That trial is designed or planned to be a pivotal trial. Provided the timing works out, as we hope, then that could potentially be a label expansion of Deucrictibant beyond hereditary angioedema to Bradykinin-mediated angioedema.
We also recently got an Orphan drug status in Europe for this new indication, Bradykinin-mediated angioedema. We also have it in the U.S. for both on-demand and for Prophylaxis. Take a look at the data in our phase two studies, starting with the prophylactic trial. You see here the percentages in attack reduction. What you look for in a prophylactic study is comparing the number of confirmed attacks compared to Placebo. We are very excited about what we saw here. This is the first time you see efficacy in the same range as with the current Injectable therapies, but in an oral form with Deucrictibant. We saw in the 40 mg per day an 84.5% attack reduction compared to Placebo. In our Open-label extension, then continuing from that, a further reduction of 93% attack reduction
compared to the baseline. The phase two trial is compared to the Placebo. We also saw in the open-label then a median attack rate of zero for every month. And 99% of days were symptom-free. For the phase three study in prophylaxis, it's the basic design you see on the slide. It's again the same design as phase two, comparing the number of attacks and attack reduction compared to Placebo. Patients are randomized two to one in an active arm and in a Placebo arm. Then with the objective to measure the confirmed attacks and also looking for other safety parameters and continue to build a safety database. The study is essentially powered with 81 patients for safety. It uses the same dose as we had in the phase two, now with the Extended release tablet formulation.
You see a small picture of it here on the top of the slide. Moving on to the acute study. Again, phase two data. On this chart, the graph here is an illustration, a conceptual illustration of the progression of an attack. The onset in the red part, and then the symptoms increase, and then the symptoms then resolve over time. What you look at in the clinical trial are the different stages of development that ultimately lead to the complete resolution of the attack. We also have in our phase three study a new endpoint called end of progression, which is right at the beginning, the first point after treatment that you measure in effect. This is an endpoint that then if positive, we can also include potentially in our label if approved.
The primary endpoint is onset of symptom relief, which is the second section here under progression of attack. The later endpoints, secondary endpoints, are the resolution of the attack and ultimately the complete resolution attack. This whole scenario, starting from the onset of the attack to the ultimate resolution, are all very important to sustained efficacy and leading to the ultimate resolution of attack in a reasonable timeframe. That is when the patient then basically is able to regain function and go back to work or doing what they were doing and have the attack behind them. You see it here clicking through end of progression, onset of symptom relief, substantial symptom relief, and complete symptom relief.
The phase 3 study is designed as a crossover study in treating two attacks in an enrollment of approximately 120 patients, including adolescents. We recently completed the enrollment in that study and are now accumulating the remaining attacks that we need to close the database. We guided the top-line data currently to Q1 2026. The endpoints are the onset of symptom relief being the primary endpoint and using something called patient global impression of change, PGIC. The further secondary endpoints are time to end of progression, that I mentioned earlier, which is the first measuring point. The patient global impression of severity and use of rescue medication and incidence of treatment with emerging adverse events and safety,
of course. Here on the picture to the right, you see the Soft gel capsule. It is also a very small Soft gel capsule, easy to swallow. It's also the portability of that is important for a patient, again, having this condition to be able to have access to therapy very quickly in the case of an attack. Pharvaris, as a company, our aspiration is to become a leader in the Bradykinin-mediated angioedema space and rooted in a deep commitment to engage with the HAE community. As I mentioned earlier, many of our team have been involved in HAE for many years, up to 20 years with some of us.
A lot has evolved in the space in the last couple of decades. We're looking forward to potentially become the standard of care in ODT when the long-term Prophylaxis market becomes the preferred leader in the preferred therapy and long-term therapy. Also, beyond, leverage our portfolio with B2 receptor antagonists mode of action, all subject to, of course, clinical trials remaining in phase 3 and ultimate approval of deucrictibant. That is a quick overview. I do not know if we have time for questions, but thank you very much.