Biotech Values

[Mufaso]

ggwpq- correct me if I'm wrong but I believe Brian said the "plan" was to start at 2.5 and eventually get to 20mg/day. The first cohort is flat 2.5mg and then they titrate up. My sense also is that Viking is much more interested in getting safety tolerability data in this study as well as looking at the concentration of the drug in blood plasma. I know everyone is focused on the "weight loss percentage" at 4 weeks but I can't stress enough how variable this is in a study that is small and only doses for 28 days. There really is a risk here that the stock might go down. (Personally- even if weight loss percentage is low , I'm ready to buy more if the stock goes down and tolerability is good plus evidence is provided that the drug gets to blood plasma in good concentration.)

Here is some info from the 1Q23 CC:

Steven Seedhouse

Great. Thanks so much for taking the questions. I had a few on the oral formulation of the GLP-1, GIP. First, just you haven’t shared any preclinical data. So I wanted to ask, in general, if the expectation would be you could get to sort of exposure and ultimately efficacy levels that would be equivalent to the injectable or what specifically would be the expectations in terms of potency of what you could achieve at peak in humans? And then also with that compound, is this something that would lend itself to like a titration schema as well? Or are you essentially looking at flat doses in the Phase I?

Brian Lian

Hey Steve, thanks for the questions. With the exposures, yes I don’t think we expect the exposures to achieve the same level that are observed with the subcu formulation. Maybe I’ll be proven wrong, but I don’t think we’ll get there. It’s almost a different product. I would consider the oral formulation, maybe for someone who first doesn’t want to start with an injectable or for someone who maybe has a BMI 32 to 34 or something that might be adequately addressed with an oral formulation or potentially in a maintenance setting where you start with the subcu and then transition on oral. So there’s a lot of different ways that it could be used. But my own guess is that we probably won’t see the same exposures with the oral. What’s the second question?

Titration, yes. So yes, we will titrate in the upcoming study. So the first cohorts, flat dosing and subsequent cohorts will titrate up.

Steven Seedhouse

Okay. So it’s just 1 dose of -- 1 tablet dose that you just give multiple pills, I guess, in that case?

Gregory Zante

That’s right. Yes. The first cohort is 2.5 mg and that’s flat. And then from there, they dose up. I mean first week will be 2.5 and then the remaining 3 weeks would be a higher dose. And then as you go on through the cohorts, you kind of titrate up per week.

Steven Seedhouse

Okay. A couple more just because it’s a really interesting program. Obviously, you mentioned maintenance dosing is one option. That’s just given how many people in the next decade are likely to be gravitating towards using incretin. I imagine there’d be some enormous group of patients coming on or having been on injectables. I’m curious if you’re going to gather that type of maintenance data in the Phase 1, can you take patients that you already treated with the injectable and start them on oral and see how they do? And then I just have one more on the program after if I could. Thanks.

Brian Lian

Yes. No, thanks. In this study, we’re really just trying to see if the formulation will provide exposures and what levels compared to subcu. So I think in the future, those transition type studies would be really important and really interesting, but this is just the first one, and we’re just going to see how the exposures turn out.

and then later on:

Andy Hsieh

Got it. Got it. That’s helpful. And then maybe lastly, for the oral formulation versus subcu, could you kind of help us think about the amount in terms of dosing from these 2 formulations on a relative sense?

Brian Lian

Yes. The oral will push up a little bit higher. We’re going -- I think the plan is to go to 20 milligrams with the oral. So not a huge amount higher than the planned dose to phase -- for the Phase 2 and the subcu.