Viking Therapeutics, Inc. (NASDAQ:VKTX) Q4 2022 Earnings Call Transcript

Brian Lian: Yes, yes. So the prior 12-week Phase II study, when we looked at the – all of the data, the efficacy data, the changes in lipids, those kinds of things. There were three cohorts, five-mg a day, 10-mgs every other day and 10-mg daily. And we looked at all the data, they all look pretty similar. And so it suggested that we were sort of on the far right of the dose response curve. Maybe that is incorrect, but that is certainly what it looked like to us. And so we felt that we had room to come down in dose. And we know that the FDA always likes to have a handle on what the minimally effective dose is. And so we looked back at prior studies and what looked like was that one-milligram dose when you look at the Phase I data it starts to look like it is affecting lipids.

And so we thought that, that would probably be the minimally effective dose. And we then dosed up from there to include a top dose of 10-mg every other day, which was overlapping with the 12-week study. And we thought that was largely equal to the five-mg daily and the 10-mg daily. And we just spread it out between those, but that was kind of the rationale.

Steven Seedhouse: Thanks Brian. Thanks for the questions.

Brian Lian: Thanks Steve.

Operator: The next question comes from Joe Pantginis of H.C. Wainwright. Please go ahead.

Joseph Pantginis: Hey guys, good afternoon, thanks for taking the question. Brian, I don’t think it is too early to ask this question, but as you look towards a potential Phase III for 2809, obviously, the clinical trial community has been gaining in their understanding and traction with TR beta on two different fronts with two different assets. So I guess with the other asset being a little more mature, how would you consider or what kinds of things are you considering to handle regarding, say, competition for patients to enroll into your pivotal study?

Brian Lian: Well, I think that there are enough patients out there to enroll Phase III studies even if there is an approved agent with the same mechanism. And we have seen that in the diabetes space in the past with multiple approved GLP-1s, there are still trials enrolling GLP-1 agonists and plenty of other indications that share those characteristics. So I mean NASH is hard to enroll under any circumstances, but I don’t think competition will be a significant problem there. It is just a hard – the hard side to enroll anyway.

Joseph Pantginis: Sure, very helpful, thank you.

Brian Lian: Thanks Joe.

Operator: The next question comes from Jay Olson of Oppenheimer. Please go ahead.

Unidentified Analyst: Hey this is on the line for Jay. Congrats on the progress. Maybe a couple from us. First on 2809. I think in the Phase IIa study, you showed the toxicity or GI adverse events were actually lower in the treatment of groups. So can you maybe just remind us if this is something related to the liver targeting property of 2809 and how should we expect the GI tolerability to play out in the AD study and maybe related to that, do you see a path forward to combine to 2809 with maybe all GLP-1 in the future? And I have a follow-up for 735.

Brian Lian: Yes, to answer the second question first. Yes, I think the 2809 could be combined with a variety of different compounds and oral GLP-1s could be one of those. With respect to the GI tolerability, we just haven’t seen anything like that in any of the prior studies. And I don’t know that it is necessarily because it is liver-targeted just something we haven’t seen.

Unidentified Analyst: Okay, thanks and for 2735, maybe just following a previous question, I know there was like a few dose cohorts were initiated maybe in the second half of last year. So just wondering, for the upcoming readout, should we expect to see data from all cohorts or only some of the cohorts? Thanks.