The third quarter was a busy period for SynAct Pharma, and they have just also received IND approval. Welcome, CSO, Thomas Jonassen.
Thank you.
What is needed to receive IND approval?
IND approval is, in principle, to get an approval to run clinical studies in the U.S. Before getting there, you need to work a lot with your package and secure that all the documentation is present and submitted and in a very good shape, for FDA to review that. We had a pre-IND meeting through the spring where we discussed the development plan and from there we, of course, got a very good input to our case. We then filed it in September, and then we got the approval here, effective from Sunday.
You're now able to initiate the RESOLVE study. Could you tell us a bit about the study design?
The RESOLVE study is where we test our compound, AP1189, a melanocortin receptor agonist, a biased agonist with a very nice safety profile and also very importantly, effective in rheumatoid arthritis from our study in the BEGIN study that we reported last year. The RESOLVE study is to test the compound in the patient population that we call DMARD-IR. That means patients who for at least three months have been treated with first-line treatment, methotrexate, and do not have control of the disease.
It's approximately 45%-50% of all patients who do not respond adequately, and where there is a need for safe and novel approaches to reduce or to control the disease. That's where we go in. It's a study in two parts. The first part is a four-week dose range study, test three doses versus placebo. When we have the result from that next year in, yeah, around a year from now or something, we can plan for the Part B of the study, which is a 12-week full Phase IIb study. That should bring us to identify the doses that could be brought into Phase III.
The aim is, of course, to show that we have a compound that's safe, effective. There's a potential in moving forward.
The rheumatoid arthritis patients are in great need of new treatments, especially those in the RESOLVE study. How can AP1189 fill the unmet medical need?
I think we can fill the unmet medical need by going in and treating the disease by a novel approach. There's a lot of very good treatments for rheumatoid arthritis, but most of them are associated with side effects, and they have the potential to reduce immune suppression, meaning that they increase risk of infections. Lately, we have the JAK inhibitors who have shown not only to have increased risk of infection, but also have cardiovascular effects. At least last week, EMA came out and say that they made restrictions on the use, especially not to give them to older patients and also patients with cardiovascular disease.
I really think there is a need for a novel compound, and a novel way of treating the disease where I think we could make a difference.
If we focus on the EXPAND study, how is the patient recruitment going?
Yeah. The patient recruitment is going really good. The EXPAND study is in the same as in the BEGIN study is in treatment in the patients. We learned these investigators during the BEGIN study, and it works very well. We started the study in September, and it runs very nice now.
You have several exploratory endpoints in the study. Why are these of value?
I think that they are very much of value, including MR scans we have in a sub -study. They are very much valued because the way we address the disease with our compound is resolution therapy, which is a novel way of attacking rheumatoid arthritis or other inflammatory or autoimmune disease. We need to get as much information as possible to put into the overall package to explain how this works and differentiate us from the other, you could say, treatment options on the market.
Are you financially and organizationally prepared for the upcoming development?
We raised money this spring here, and we do have the activity that is associated with our development in rheumatoid arthritis and also to support the continuous development in nephrology that we have on the side. That is where we are right now. We do have a lot of ideas, including with AP1189, what we could do better and not better, but expand into additional indications. We also have potential new compounds. Right now we have to focus.
Do you still have ongoing partnering discussions, or are they on hold for now?
No, we have continuous discussions, especially here after the IND. We are going a full round again and discuss with them. Our U.S.-based business developer is in continuous discussion with the potential partners. Of course, they are waiting for data as we are. Now we have initiated these studies, and they are very eager, as we are, to get the results.
Interesting. Thank you for watching this interview with SynAct Pharma CSO. Thank you, Thomas, for joining me in the studio.
Thank you.