Home » Arrowhead Research Corporation (ARWR) Q4 2014 Results Earnings Call Transcript

Arrowhead Research Corporation (ARWR) Q4 2014 Results Earnings Call Transcript

Christopher Anzalone: Yeah. So, Ted, thanks for that question. We don’t have data in the woodchuck model. That’s a different virus. It’s similar but it’s different, and so that would require different sequences and it’s not clear how illuminating that model would be. So we didn’t look at that.

Generally, we see the additive effects in multiple animal models across target. And so we take a lot of solace in that and believing that we’ll see this additive or step down approach on multiple dosing. And of course, we look to what other companies have done in RNAi, and you’ve seen the similar thing where you get an additive or step down approach. And so we expect that but at the end of the day, we see that in humans and that’s why we are moving as quickly as we can into the Phase 2b studies even while we are working on the 4 mg/kg, single dose study, we’re moving into the Phase 2b multiple dose studies because that’s where we start to learn a lot about our drug. That’s where we start to learn a lot about how we might optimize the therapy.

Ted Tenthoff – Analyst, Piper Jaffray

Fair enough. Okay guys. And when will you be able to articulate in more detail, more clarity on what some of those studies are going to look like and when they will be starting?

Christopher Anzalone: Some of that, as I mentioned is really iterative process. And so while we have ideas for several of them, I think that as data come in that multiple dose studies, we’ll see things that will surprise us and will frankly surprise the whole field, because we’ll be doing something that the field has never been able to do before and so new ideas will come.

I think that we’ll start to give some guidance in early 2015 as we start to submit filings for some of those parallel studies and then we’ll keep you up to-date in as real time basis as we can. Again, I suspect that in the first half of 2015, we will start to add additional parallel studies, and as we talked about, the ones that you could imagine of different dosing schedules. We always thought that we wanted to look at dosing ARC-520 every two weeks, in addition to every month, but now given the duration of knockdown I think that we may try longer dosing intervals. And then of course, we’ll be interested in looking at combination with interferon as well as other immune stimulatory agents. So once we get our two big anchor studies underway, we can focus on some of those smaller studies and we’ll let you know the specific design of those as we apply for them.

ALSO READ:   Vodafone Group (VOD) CEO Vittorio Colao on Q1 2015 Results - Earnings Call Transcript

Operator: Thank you. Our next question comes from Alethia Young from Deutsche Bank.

Alethia Young – Analyst, Deutsche Bank

Great. Thanks for taking my question. A couple of ones. One, are you leaving the protocol open in Phase 1b?

Bruce Given: You mean the Phase 2a study, is that what you mean? Well, we can talk about that. So far our plan is to start with 4 mg/kg. And then of course we’ll have 85 days. So I guess, there’s always be the possibility we could go higher but it’s not our plan at this point. If that’s really your question.

Alethia Young – Analyst, Deutsche Bank

Yeah. And then I guess, what would influence your – what would be the factors that would make you go out and leave it open? Are there any at this point?

Bruce Given: It’s hard to speculate. I mean I suppose if we saw something in the knockdown that made us think we wanted to try our higher doses and our investigators were game for it, I suppose we might but it’s surely speculative. I mean it’s not our expectation that we’ll need to go higher or want to go higher but I suppose we could.

Christopher Anzalone: And importantly, there has been no data to live in our ability to do that. The safety profile has been so good that if we wanted to go higher there is – we haven’t seen anything that would keep us from doing that. At this point we don’t – we’re not planning on that.

Alethia Young – Analyst, Deutsche Bank

Okay. And then just thinking a little bit about, or kind of flipping the study – getting the go ahead to do like the United States, Europe and different areas. How do you think about the risk of that as far as what you’ll need – what the FDA needs different than anything else, we’ve seen RNA or just kind of if you can help characterize that timeline risk and just risk in general after that submitting that package?

ALSO READ:   Transcript: Arianna Huffington on We Are Drowning in Data and Starved for Wisdom

Bruce Given: Yeah, Alethia as you know it’s always unknown, we like the data package, we think it’s very solid and very complete, but one variable until the first time you submit to the FDA, is the first time you submit and it’s hard really for me to gauge that risk. We feel like the clinical data is very strong. We feel like the tox data is good and everything else, but ultimately they – as we always say, we submit, they review, they decide. And that’s always the case.

Pages: First | ← Previous | ... | 7 |8 | 9 | Next → | Last | Single Page View

Leave a Comment