SynAct Pharma is a Danish-Swedish biotech company who is listed on Nasdaq Main Market. I'm the Chief Scientific Officer and also co-founder of the company. Very briefly, we have been listed on Spotlight almost nine years ago now, and we are developing our main asset is a small molecule, resomelagon, also called AP1189. That is, we are developing that actually in a dual development strategy. Our main project and what we have highlighted several times is in newly diagnosed rheumatoid arthritis patients, but we also have a program that we will, that also we have funds to move forward in as host-directed therapy in more severe viral infections. I'll try to explain that over the next minutes, what this means.
We do have financing in 2027, and we are looking very much forward to having data next year in our main project in rheumatoid arthritis that we with the expectation that we would then have significant business development activities. The potential of resomelagon is that it's the first in class non-suppressive therapy for inflammatory and autoimmune diseases. What you could say is that most, if not all, compounds currently used in the clinic for inflammatory diseases, autoimmune diseases, where rheumatoid arthritis is an example, do have anti- or immunosuppressive capabilities. One of the main side effects of current treatment is to induce immunosuppression with increased risk of infections. The way we address the diseases are somewhat different, and I'll try to explain that. One of the main targets are macrophages, which recently have been highlighted as a key cell type in early stage and even pre-stage of rheumatoid arthritis.
I actually think we are pretty much where we should be with what we are doing right now. We, as I said, have like two programs. We do have our rheumatoid arthritis program where we are in phase IIB development based on previous data. Very importantly, going in newly diagnosed patients with high disease activity, what we could call poor prognosis factors, meaning that there is a high risk of early irreversible loss of functionality in the joints, but also patients who typically are more difficult to treat, where you have to use glucocorticoids and in many cases have to stay on that for longer periods, which really is not good for the patients.
We, initial indication is our first line where we give it to standard therapy on top of first line treatment, methotrexate, and then we see potential indications in flares, meaning that it's a later stage when you have increases in disease activity, whereas we see ourselves as an opportunity to go in and treat that for periods in these patients. I come back to a slide on where we are moving in the next 10 years in rheumatology. The other program we have is this host-directed therapy in viral infection, and that is really what we learned during the COVID pandemic is that the virus can induce significant super or you can say hyper-inflammatory responses in patients who are the main challenge.
The main reason to why we have respiratory insufficiency during the COVID was an accelerated inflammatory response where macrophages play a significant role or key role for the development of the disease or the symptoms. There we showed in a phase two study that we actually could treat these patients to get them faster to recovery and faster out of hospital. That is what we are following now in additional program. So far we have put it all into what we call RESOLUTE. RESOLUTE collaboration with resolution in viral infection, which is based on scientific collaboration with very key scientific collaborators around the world. The concept of our treatment is not to make a lot of noise about the spend a lot of time here, but most compounds do work that they suppress an immune system.
Immunological responses are good by principle because it's tissue protection and it secures that the homeostasis of organ and tissue and the body is in the right shape. In diseases, it can be exaggerated and then it becomes, you could say, no good any longer. That's where we see we can do a difference because one way is to suppress the immune system, as I said, and then you have an increased risk of infections among others. You could say you then suppress the symptoms, but the disease is still there. If you can set the immune system to a new set point, you could say modulate it by less inflammatory activity and boost what we are calling proven solving pathways, meaning that they help up clearing the inflammation, then you might could do a difference.
That is where we see our treatment, and that is this relatively new area of calling resolution therapy. We are stimulating melanocortin receptors that are present on white cells and especially neutrophils and macrophages, and macrophages play in our world, in our current study, a significant role. We know from these macrophages that they can be very pro-inflammatory, meaning that they induce inflammation and exaggerate inflammation, but they can also help up clearing inflammation, what we call resolution. That is based on their phenotype. You could say classical M1 macrophages are pro-inflammatory, classical M2 macrophages are pro-resolving, and we shift them to a type two alike phenotype with the ability to what we call efferocytosis, meaning that they help clearing up the inflammation, including clearing out neutrophils that are apoptotic and thereby reduce, set a new set point for the inflammatory system.
Our pipeline, we do have our rheumatoid arthritis program in phase II B. It's run under a U.S. IND. We are currently recruiting to a 240 patient study, and we have more than 80% of the patients recruited. We will complete recruitment in relatively near future and then with key results next year. Host-directed therapy, we are looking very much into that in two, you could say, path. One is arboviral infections, which is most the highest needs for treatment right there is in the third world, but that is something that will and has been established also in southern part of the U.S. and southern part of Europe. Also in respiratory insufficiency, patients who are coming to hospital with viral infections, influenza, RSV, COVID do still have a large need for that. We also have another.
If we look then at rheumatoid arthritis, early RA, that is where you in the current guidelines should go in and treat as fast as possible. There the main problem is that we use too many compounds with unwanted side effect profiles, and we believe that we can reduce the use of glucocorticoids, we can reduce or postpone the use of second line treatment and potentially with the potential to give the patients, you could say, a better life in parallel with that they have disease control. You can also go any more progressive disease, and especially there we see flares. Importantly for the future, unclassified arthritis or even pre-arthritis. That is, I believe, and I'm not the only one because there's just been a brand new paper from the European and American rheumatologist classifying this as a potential new target for development.
There I think in these three groups of patients we fit extremely well. This is from our previous study showing that newly diagnosed patient high disease activity, we have significantly higher response rate than in patients who are on placebo on top of first line treatment. That's not only on the ACR score, but also on clinical scores DAS28 and CDAI. We are currently running this study where we will have a major readout next year. The aim is to, of course, to increase the treatment compared to placebo. We are taking three doses of active versus placebo on top of standard therapy, 12 weeks dosing, and fit into the current treatment guideline. The other program is in the viral, and here just to highlight that there is a large medical need.
We have 1 million patients in the U.S., at least 1 million patients in the U.S. and Europe that every year is referred to hospital with respiratory insufficiency due to viral infections. From our compound, we strongly support by preclinical as well as clinical study here in the COVID. We know we have shown that we can get the patients faster to recovery and faster out of hospital. That is the parallel track that we are going to initiate here and continue it, including a study in dengue together with one of the most bright collaborators I ever have worked with, Professor Mauro Teixeira from Belo Horizonte. We are running our clinical studies, most focused, of course, on our ADVANCE study, but also on our RESOVIR study. We are looking into additional opportunities to set up here during the winter.
The ADVANCE would be on back of that. Of course, we also already are planning next steps, but the study will come next year. dengue will also come here during the next pandemic or epidemic in Brazil here during the first month of the next year. We are building additional also with outside the target of today pipeline in peptides. Of course, it is time for us also to focus much more on business development. We are doing that, of course, because if we are going to bring this compound into phase three, we would like to do that with a partner. I think that is the story for now. Yes.
Thank you. A question about the competition. Are there any competitors or adjacent technologies that you are watching more closely than others?
There is. I think that one thing we have learned is that resolution therapy, the way we have addressed that, we are probably on the front end of development there, at least for an oral compound. There have been other companies working with that. BMS had one in cardiology and Actelion had one. In both cases, they were from strategic point of view has not developed further. I think from a safety perspective, and importantly also what we hear when we talk to potential partners and the environment is that there is much more understanding of what we are doing now than there was just a few years ago. This to go in with a patient-friendly oral once daily treatment that is well tolerated is really something that we are looking for. We are first in class, yes.
As a final question, because obviously you had to rush a bit at the end, someone just asked you to elaborate a little bit on what will happen during next year in 2026. What are the milestones and what's the funding?
The milestones, of course, more than anything else. We do have a large investor base. I think we have more than 15,000, and they are looking forward to the data. That would, of course, be the key. We will come out with more information on this as soon as we have completed the recruitment where we are well. It would come in a not so far future. That would be in the first half of next year. That's the most important. Others, of course, also we have a lot of questions about our dengue study.
We are ready at several sites in Brazil. It comes like with the mosquitoes. Last year it was a very small epidemic. The year before it was gigantic. You're waiting for the mosquitoes. Yeah, we are waiting for the mosquitoes. We are setting this up together with our collaborators there. We are ready to take that. That's the two main, you could say. We work with additional opportunities within our current funding because we believe that we can do so much more. Their respiratory insufficiency is something that we will update you in the not so far future.
Thank you so much, Thomas.