David Young : Well, so for the 300-milligram group, we already have some patients enrolled. We have been pushing the sites to enroll more quicker. And so, we’re pretty confident we’ll have it done in the next month or two, all right? The question then becomes do we go to the next cohort, or should we be going to the next cohort after that? We won’t know that until we see the doses or the safety profile from the dose that we’re presently on. We’re still going to the FDA, though, in mid-April because regardless of having it, we know that one of the dosing regimens that FDA will want us to take into the Phase 2b will be that MTD — will be that MTD dose. And so, we will be using that. So it doesn’t prevent us from meeting the FDA — with the FDA.
It doesn’t prevent us from initiating things in terms of protocols and getting CROs selected. It doesn’t prevent us from doing all that. But we won’t know the exact dose or the exact dosage regimen until we get to that MTD, which, again, we project it will be in mid-year.
Naz Rahman : Got it. And on that Phase 2b protocol that you plan to discuss with the FDA, could you provide some potential color in what you expect the Phase 2b or what are you thinking the Phase 2b might look like in terms of study design?
David Young : Yes, I prefer not to discuss that right now until we negotiate a little bit more and discuss it with the FDA. But it’s going to be a more typical efficacy safety study, where we’re looking, of course, at efficacy and safety. We are going to be talking about probably anywhere from three to four groups with different dosing regimens and potentially a control group with the established dose. So again, we are proposing something to the FDA and trying to figure out how what how they’re thinking about Project Optimus. And based on what they share, we’ll be able to figure out how they’re thinking about it a little bit more and then be able to tweak our study to — not only the needs of getting into Phase 3, but also fit the needs of the answers and questions that FDA might have.
Naz Rahman : Got it. And I’m going to shift gears a little to on 3117, a few questions here. Previously, you mentioned that you guys are developing a macro molecule assay. Have you on completed work on that, and what might it look like? Is it like blood based or biopsy based, and are you still working on this project?
David Young : Yes, we are still working on it. But if you think about how biomarkers are evaluated at FDA, identifying a potential biomarker is the first step. That’s all the analytical procedures, et cetera. That’s the step we’re at right now. The next step in the biomarker work is that you have to prove there really is a biomarker. So our hope is that we will have the analytical part done. And then, at the end of the year, we’ll be able to submit the protocol to the IND for a Phase 2b trial. And that Phase 2b trial will be the one that says, is it really a biomarker? Even though the analytical is done, you have to prove biologically and clinically it is a biomarker. So that will be done also at the same time in the Phase 2b trial.
So we’re not using it. We’re not going to be using the biomarker to say these are the only patients to study. We cannot do that because we don’t know it’s a biomarker because there hasn’t been a study yet. So that’s the Phase 2b study. We’re looking at efficacy, safety, as well as determining if this analytical measurement of a macro molecule is really a biomarker.
Naz Rahman : Got it. And the biomarkers you’re evaluating, are they blood based or biopsy based?
David Young : I can’t comment on that right now.
Naz Rahman : Okay.
