Arbutus Biopharma Corporation (NASDAQ:ABUS) Q1 2024 Earnings Call Transcript

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Karen Sims: Sure, absolutely. So the target enrollment was 20 subjects for that arm to be consistent with the other two arms of the study, as often happens in these studies, we have screening open to many sites in many countries across the globe and we can’t necessarily control the number of subjects in screening at any one time. So it just happened here that we had a couple of additional subjects that were eligible for the trial and had completed screening, so we did allow them to enter the trial, but that’s the only reason for the 22 subjects as opposed to the 20 subjects. And as said previously, we’ll be sharing the preliminary end of treatment data from that trial in the second half of this year.

Operator: The next question comes from Keay Nakae with Chardan.

Keay Nakae : Yes, just some follow-ups on 101 study. In terms of the receptor occupancy, is the assay you’re using, is that a standardized or do you have to customize it for this?

Mike Sofia: Hi. This is Mike, Keay. It’s an assay we actually developed internally, so it’s a proprietary assay that we use for getting that target occupancy readout.

Keay Nakae : Okay. And is the dose response you’re seeing, is that consistent with what you’re supposed to see?

Mike Sofia: Well, I would say preclinical models, we see 80% to 100% receptor occupancy. So that gave full efficacy for us. So I think what we’re seeing in the clinical study is very encouraging to us.

Keay Nakae : Okay. And then in the multi ascending dose part of the study, just remind me again, what’s the dose frequency? How often is it?

Karen Sims: So it’s a total dose duration of seven days, and we do have flexibility within that arm to dose every day or anything different than that depending on how the data reads out. So it could be a daily dose. It could be every other day, every third day, that part will be determined as we evaluate the safety PK and PD data that comes in from the different arms of the trial. But it’s a seven day maximum duration.

Keay Nakae : Okay. And when do you expect to be able to advance into part three of the study?

Karen Sims: Right. So it really depends on how these multiple ascending dose arms proceed in the healthy subjects. So really, we just need sufficient, again, safety PK and PD data to feel confident to move into that third portion of the trial and to choose a dose to initiate that part of the trial that we think will have impact in these chronic hepatitis B subjects. So, again, it just depends on the progression of part two of the study. But it is, as we’ve said earlier, an integrated protocol. So the part three of the study is already approved and we would be able to move on as soon as we are ready with the data. Thank you. I’m showing no further questions for the first time. I’d now like to turn it back to management for closing remarks.

Mike McElhaugh: Great, thank you. Thanks everyone for joining us this morning. We appreciate your continued interest in and support of our Arbutus. And we look forward to providing updates to progress the development of our HBV assets. Operator, that concludes our call.

Operator: Thank you for your participation in today’s conference. This concludes the program. You may now disconnect.

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