DiaMedica Therapeutics Inc. (NASDAQ:DMAC) Q4 2022 Earnings Call Transcript

And we’ll give us just some additional data here to support this trial. And I think it’s going to help with enrollment after the trial is up and running.

Alexander Nowak: Okay, that all makes sense. A question that I think still sits out there is did we know the correct dosage going into patients for the Phase 2 stroke study done in Australia going back a couple of years ago. So I mean, I know we don’t have a clear answer on that, but what’s the risk that the FDA, even when you provide all this information back to them, they say, okay, fine, but we’d like you to do another Phase 2 study before relaunching this Phase 2/Phase 3 study?

Rick Pauls: Sure. So the initial Phase 1 study we did support the Phase 2 for stroke. That study was really designed on the IV portion was to match the drug levels. So the PK profile to what’s been shown with the Kallikrein, the human urinary form. So we did that with the polyolefin bag and then we went to our Phase 2 trial and we used the same bag. And so then what we discovered here is that close to half of the drug was sticking, we went pivoted to the Phase 2/3 with the PVC bag and effectively we were overdosing by twofold. So we’ve now confirmed this now in two studies, the IV bag study we did last fall and then now with the In-Use study. So we feel that for us and patient safety, we think we’ve identified the right range. But we’re going to also have this data here in really a matter of weeks on from this additional Phase 1 trial that’s on-going.

Alexander Nowak: Okay. And walking through it like that, I think that makes sense. And I think that should be a good argument to the FDA. Final question here. Once the clinical hold is lifted, maybe it’s in the May-ish timeframe, how quickly can you reactivate sites and start enrolling patients? Are you really starting from square one there or can these sites activate or reactivate relatively quickly?

Rick Pauls: Yeah, I mean, before we had the clinical hold, I mean, if you’re looking at clinical trials like that, we had 15 sites. Really, we’re going to do all we can to get that up and going. I think importantly, you know, with having, you know, Kirsten and Julie joining our team since last year, I think we’re going to be in a lot better position here to, you know, get this this study up. It’s going to take, you know, it’s going to take a little bit of time. But I think importantly, after we get it up and running, we’ve been doing a lot of work since then and just getting all of our documents, materials cleaned up and in really good shape. So as soon as we get off, you know, after we get off the clinical hold, we’ll provide an update here in terms of some of the timing.

Alexander Nowak: Okay. Appreciate the update. Thank you.

Rick Pauls: Thanks, Alex.

Operator: Thank you. And our final question comes from Francois Brisebois of Oppenheimer. Your line is open.

Daniel Hultberg: Hi, guys. This is Dan on for Frank. Thanks for taking my question. Just a follow-up from the other two on the Phase 1C study that’s on-going. Could you share some color on the doses that you are going to be using in the single ascending dose study? I believe the original Phase 2, the original plan for the ReMEDy2 was to use both 1 microgram per kilogram and 3 microgram per kilogram. So just in terms of what the maximum dose that you’re testing in this study? Thanks.