David Young: Yeah. That’s a good question. Fortunately, FDA has put out a guidance on gastroparesis. Because there’s nothing being developed in gastroparesis specifically or there’s nothing approved, I should say, there are a few drugs being worked on, they put out a guidance. So the expectation is that every company follows that guidance. And that guidance says, you administer the drug at minimally for 12 weeks. Right? So there’s minimally a 12-week treatment. You can go longer if you want, but you can’t have any less. And then again, you have the symptom score that FDA approved already, that I talked about earlier, but the treatment has to be minimally 12 weeks. And then again, you can go longer. One of the things we would be going — we will be going longer in terms of treatment, though, because we need safety data longer than 12 weeks.
We need to have one year safety data. So there will be some patients who will go out to a year. Primary endpoint for the Phase 2B study will be at 12 weeks or 16 weeks or shorter time. But the patients will be going out longer, so we can have larger safety information, more safety information for a longer period of time.
Naz Rahman: Hey, David. On that 12-week comment, is that because the currently approved drugs, they can’t really be used for more than 12 weeks safely or is that —
David Young: That —
Naz Rahman: Yeah.
David Young: Yeah. Good question. Good question. No, that could be one reason that they’re doing it because they know all the data that they have is on metoclopramide for 12 weeks. That’s all they have in terms of that’s good application status. So that’s why we say minimally 12 weeks. I think that is one reason. I think the other reason, though, is in terms of the long-term effect of the drug on the GI tract, you need to continually give the drug. You need to have more than just the short acute treatment, because this is a chronic disease. Because a lot of the symptoms don’t occur right away, but they occur after you’ve had the condition for a while. So some patients for example, have gastroparesis, and they’ll have one or two symptoms.
And then after a year, they’ll get a couple more symptoms. So the symptoms don’t all come exactly at the beginning. And so I think they want to make sure that you are treating the condition and you’re seeing symptoms improvement over time. We will be looking at symptom improvement over time for that study and expect you expect us to do that. So I think it’s one further reason you said, possibly because of metoclopramide 12 weeks. But it’s also because they want to make sure that this can be used chronically in the long run.
Naz Rahman: All right. And on the patient population itself, could you just quickly remind us, the patient enrolled in this study, were they mostly like diabetic gastroparesis patients? Are they — or did it also include like post-surgical gastroparesis patients?
David Young: Most of these were diabetic gastroparesis patients. We did have a few idiopathic gastroparesis patients. We did not take surgical gastroparesis patients, because they would have came out of surgery. And we did not want to deal with the side effects that might be going on with post-surgical issues and things like that. So we did not do any surgical — take any surgical patients.
David Young: Got it. I just have one last question, and it’s actually on 3117. Have you determined like your path forward on this asset? And what are your development plans here?
