Naz Rahman: Hey, guys. Thanks for taking my question and congrats on all the positive data thus far. I want to talk a little more about the gastroparesis data. So first off just on the symptom measurements we could expect at the end of the year. Could you just give us more color on what we could expect to see, and what you’re hoping to see? Or what you’re looking for?
David Young: Sure. Hi, Naz. So what we have — there is a scale that is an FDA approved, validated scale for gastroparesis that looks at symptoms. And it looks at most of the symptoms that we described in the slide deck. And what we expect to see in the 2A, in our present study, is we expect to see a trend for some of those symptoms. Now this scale sums all the symptoms, but — so we will look at all the symptoms cumulatively. But then we’ll also look at individual symptoms, right? And we’ll see if the cumulative number — the cumulative evaluation shows a trend towards improvement or its individual symptoms that show a trend. FDA allows us to move forward in a Phase 3 study and get approval on either the total symptom score or even subcategories of symptoms. So we’re looking for both, so that we know exactly where our drug helps in terms of symptomology. It’s critical. Remember that FDA only approves a drug based on symptom improvement, not on gastric emptying.
Naz Rahman: Got it. So on that point from a regulatory perspective, you do not hypothetically have to show a statistically significant difference on every symptom? You can just show a difference on a composite score, right?
David Young: That’s correct. That’s correct.
Naz Rahman: Okay. So my other question was, over the 20 days, the rate of gastric emptying, did you see the rate of gastric emptying in these patients increase over time? Or did you see like a certain level of emptying, like early in the study were just relatively, let’s say, maintained through the 28 days?
David Young: Yeah. We’d actually didn’t follow it over time. We actually looked at beginning and end, because we wanted to treat them. So we don’t know what happened at time across the days of treatment. We did not study that.
Naz Rahman: Got it. Did you see any discontinuation in the study?
David Young: We did. A couple patients did drop out. But they did not drop out because of the side effects. They dropped out because all of a sudden, they said, we can’t come in to get our tests done. And so that was unfortunate. But again, it wasn’t because of adverse events that they dropped out. It was purely because they didn’t want to travel and to get tests done.
Naz Rahman: Got it. And the age you saw in the study, did any of them require any form of intervention to address? Or did they just mostly go away on their own?
David Young: Yes. They went away on their own, and they went away really early on. All the adverse events were mild to moderate type of adverse events. And so there was very little, few things that were happening, nothing that anybody couldn’t get through. Nobody dropped out because of those mild to moderate symptoms — those mild to moderate AEs. Everybody was fine to continue on except that two patients didn’t want to travel anymore. So there wasn’t a problem because of that.
Naz Rahman: Got it. All right. So like gastroparesis is mostly a chronic condition and 20 days off the short study, you’re just looking for trends here. But in your next study, the Phase 2B, what are you thinking in terms of like a timeline? Or how long the study would be? Would that be like over a year, like 52 weeks? Or what are your thoughts around that?
