Joining us now is Bernd Modig, CEO of Farvares. Mr. Modig is a Co Founder of the company and has served as Chief Executive Officer since inception. He is also Director and prior to co founding the company, Mr. Modik served as Chief Financial Officer of ProSensa Holding, a biopharmaceutical company focused on novel RNA modulating treatments for rare diseases like Duchenne muscular dystrophy from March 2010 through its IPO on NASDAQ in 2013 and until its acquisition by BioMarin Pharmaceuticals in January 2015.
Farvaris is a clinical stage company focused on bringing oral bradykinin B2 receptor antagonist to patients By targeting this clinically proven therapeutic target with novel small molecules, the Farvaris team is advancing new alternatives to injected therapies for all subtypes of HAE and other bradykinin mediated diseases. Company brings together executives with a breadth of expertise across pharmaceutical development and rare disorders, including HAE. And I'm looking forward to Bert's presentation. The company has also quite recently IPO ed on NASDAQ raised over $300, 000, 000 relatively recently and has achieved close to $1, 000, 000, 000 market cap and all this in a relatively short period of time. So without further ado, Bert, welcome you to the floor.
And it's yours.
Yes. Thanks, Chris, and welcome, everyone, and thanks for attending the presentation. So let's see here. So you have to show you this as a public company now, the forward looking statements and disclaimer regarding that. I'm sure you've seen that many times.
So I'd like to give you, before we dig in here, an overview of Favaras, the key to highlights of the company. We focus on therapeutic area hereditary angioedema, which is a rare disease indication. It's currently a large global market of around DKK2 1, 000, 000, 000 plus in revenues. But it continues with a robust growth potential because the HAE patients are still looking to improve how they manage their disease. And that makes it interesting as rare disease markets because it's on the 1 hand, it's established, but also with a very strong growth potential.
We addressed that with an orally available small molecule targeting the B2 receptor pathway. It's a proven target. There are over decades of experience with that pathway with econoblastosis, acute treatment with HAE, which is the drug that the team that Savar has also developed at a prior company, Gerini. We have a favorable PKPD profile in this molecule that makes it suitable for both prophylactic and on demand treatments. That's the company's strategy to develop for both the full spectrum of HAE.
And there are also potential opportunities for expansion into other reticulum mediated diseases, the scientific expertise centers around that pathway and our knowledge and expertise about the B2 receptor. And the team that you see here on the next slide, in addition to myself, Jochen Knollner is the CSO. Jochen and I worked together at Turin, and Jochen is the inventor of the cataract fertilizer for acute treatment of HAE. And also recently, Pam Liu joined us from Takeda Shire a year ago and sounds recently, but it's a year ago. And she was part of the Global Program Lead for TAKHZYRO, which is a product for prophylactic treatment of HAE.
This is an overview of our pipeline in our B2 receptor mechanism. And we have concluded our Phase 1 work with PHA-one hundred and 21. That's our basic molecule, in the API. We completed Phase 1 in MAD. And we have just very recently started the on demand study for using a small capsule formulation of our same API of IN-1 hundred and 21, NETSCO-four 16.
And that study has already started, the Phase 2 study. And then we also plan to start the prophylactic study in hereditary angioedema, also using initially the small capsule formulation to get the initial efficacy data and product safety data in the Phase II study expected to start this year. And then for the prophylactic product, it's the 7/19. That's an extended release tablet formulation that we are developing and we will conduct a Phase 1 study start this year, the bridging study then to ultimately then use 719 in the registration phase for prophylactic treatment. And then we also have we're going to stay still are still undisclosed programs in other B2 related indications.
And we have exclusive rights to everything in our pipeline at this point. Hereditary Endoeba is a rare disease. As I mentioned, it's a genetic lifelong condition characterized by attacks of swelling. And it's also a potentially life threatening condition. If these swellings occur in the larynx, it can lead to suffocation.
The attacks are completely unpredictable in frequency, location and timing and severity. It's not fully understood what causes it, which adds to the anxiety level in a lot of patients. They have to when they've lived waiting for the next attack, not knowing when that's going to come and how severe it will be. If it's the Interrupting,
Vic, would you mind just putting it into full screen? It's a little bit harder for us to
Yes, sure, sure, sure. I forgot about that.
Thank you very much.
Yes, of course. Is that better? Yes. So if left untreated and the TAC lasts multiple days, they're commonly painful and could lead to hospitalization in multiple sick days. The prevalence is around 1, 000 to 10, 000 to 150000 translates to around 6, 600 patients in the U.
S. And around 8, 900 patients in Europe. And there's still globally a large undiagnosed population in HEE. The median attack frequency you see here on the right is around 14 attacks per year, but it is very, very rough between patients. And the most patients have somewhere between $12.24 tax per year.
The mechanism behind HAE is an uncontrolled release of bradykinin And our molecule PHA-1 hundred and 21 is designed to block the signaling bradykinin. Bradykinin binds to the B2 receptor ultimately in the cascade that you see here on the left. And that is what causes the umphedema or the swelling in the HIV patients. And the current approved treatments for either for on demand or for prevention for prophylaxis. And other approaches are plasma caliphene inhibition further up in the cascade.
Cascade. All products except 1 very recent are injectable. There's only or 1 world product recently approved. And the current therapies are efficacious, but they often have injection site reactions and lead patients to delay treatment and also to risk attacks. It's time consuming, etcetera.
So it's a big unmet need for HEE patients to find better treatments options and then oral is really what HAE patients and our experience and view are looking for. Icadimab is also an injectable, but it's also it's a beta kind of B2 receptor, and it's a predominant therapy for treatment of acute attacks. And in our view, addressing this at the end of the cascade has a lot of advantages and allows you to potentially also treat other forms of an edema that are not related to the plasma caliphenine pathway. The need for an oral is very clear from what we see from also from KOLs and patients. And that is the next thing for what patients are looking for, as you can see from the testimonials on this page.
Our molecule PHA VAD21, as I mentioned, I completed the Phase 1 SAD and single ascending dose and multiple ascending dose trials. And to date, in those studies, they've been well tolerated, no severe adverse events. And it has been very mild, very favorable profile so far. So and also no clear differences in adverse events between different dosing regimens versus placebo. And then no significant changes clinically in ECG or safety lab assessments and so on.
So it might have been a bit favorable profile from a safety perspective so far. And PSA-one hundred and 21 also has a very attractive PK profile. It dose proportional and it's with single or multiple or other administrations. You see here the PK in multiple doses from 1 milligram to 14 milligram in a linear fashion, dose dependent and dose has a rapid exposure. The uptake is extremely fast.
It's delayed slightly with food, the Tmax about 2 hours, but that has no impact on the therapeutic of any therapeutic significant. You see on the curve to the right, the difference between fed and fasted. And the food effect reduces the Tmax extents, the duration and but the uptake at above expected therapeutic levels is extremely fast. So there's no impact on food in that regard. The half life is longer than nicadibat.
It's about 3 almost 3 fold longer than nicadibat. And the MAD data also shows that you reach steady state exposure relatively quickly in the 72 hours, which is also a potential advantage also in the prophylactic setting. You can be more flexible to go on and off the prophylactic TRV. You don't need to build up over a week or 2 weeks. With PSA-one hundred and 21, we have done a bradykinen challenge study to look at the comparing it to study that was done with icaliban to come up with the right dose.
So with icaliban, that's many years ago also reviewed by the FDA. And that is in that predicated challenge study, we look at the effect of the molecule and inhibiting the clinical effects of bradykinin administration. And the single dose of PHA-one hundred and 21 is expected to have a similar PK pharmacodynamic effect as 2 injections of the catiban. So as you can see here at the bottom of the graph on the left, the top graph on PK is very the exposure is less because the potency is much, much higher than the cataract, but the PD effect is expected to have longer duration than the cataract. And on the products, the CEP-four 16 and CEP-seven 19, these are cartoon representations of what you're looking for here.
On the soft capsule formation, past onset is important for on demand and with a reasonable duration to cover the attack. And but on the prophylactic side, of course, the uptake is the speed of the uptake is less important that you want to have longer duration than to maintain above therapy purely to plasma target levels. Our Phase II study in on demand is already underway. This is an overview of the study design. We started it.
This is planned in 3 different doses, and we plan to that study, to evaluate the symptom relief within 4 hours in acute attacks. And then patients with HAE type 1 or 2, It's also patients are also the role control in this study. So each patient will treat 3 attacks, 2 with drug and 1 with placebo. The primary endpoint is the VAS for our post dose system relief and around 54 patients in the study. And the nice thing about HAE, specifically also in this case, we expect that the study design and the primary endpoint is validated in hereditary MG also from a regulatory perspective.
On the prophylactic side, we will enter the prophylactic study also this year initially with 416 to maintain momentum while we are in parallel developing our extended release tablets 719. And the primary objective of that Phase 2 study prophylactic is to assess safety and also get initial efficacy data. And then we will do a start of Phase 1 study then with the extended release formulation to the bridge for 416. And we anticipate then that 719 will be included in the pivotal trial. We have initial data and also looking at the PKPD effect based on derived from the bradykinin challenge that suggests that the PSA-one hundred and 21 can reach exposure 4.5 times over EC50 with the twice daily dosing based on the current formulation of 4.16.
And the 4.5 times EC50 is translates to comparable to the current TECSYRO 87% attack reduction. Then on the financial, I had us corporate had us to wrap it up. As Chris mentioned in the beginning, we are well financed. We raised $353, 000, 000 capital since the inception of the company 5 years ago. In fact, the DKK310 1, 000, 000 of that was raised in the last 9 months.
And we did our IPO on NASDAQ on February 5. And that wraps up our presentation. It's a quick flyby, but hope they're open for some questions.
Great. Thanks, Bernd. I think we have time for 1 question, And maybe I'll do the honors. It's so it's quite an achievement 5 years, dollars 1, 000, 000, 000 market cap NASDAQ listing. The product seems quite well differentiated and there's clearly an unmet need for that.
What's the next steps for the company? Just in your vision, you have the dry powder, so to speak. Where do you go in 2 years, 5 years from now?
Well, our strategy is really to focus on bringing our HAE prophylactic non demand to patients as fast and effectively as we possibly can. And so that's really the core focus of the company at this point. And then we also have looking starting to look into other opportunities related to the B2B mechanism. We will slow premature to talk about specifics there today. But in due course, we will also inform a bit more about what we're going to do there.
And as a small company, the focus, of course, is to prioritize our HAE program, which we've built into being an oral therapy for HAE patients that we believe is a great unmet need for this patient community.
Great. Well, thanks, Bert. We wish you luck with that, and we'll be following Fabaris.
Yes. Doing great. Thanks a lot.