Jerry Jabbour: So, — and just to add to that, Julian, I think one of the benefits is that the control arm is not changing. And that’s important when you think about this as a composite endpoint. You would be ordinarily — you don’t see a superiority endpoint certainly in an antifungal trial. And certainly, you wouldn’t exercise a superior — you wouldn’t add a superiority endpoint if you were just going head-to-head, for example, on all-cause mortality with IV amphotericin versus oral amphotericin. But what the composite endpoint does, especially being able to define it as therapeutic success and include a change in treatment regimen, for example, you’re going to have a control arm in this study where any change from IV amphotericin in the control arm is going to be viewed as a failure potentially.
And you’re going to contrast that with oral MAT2203, which we’ve seen in other instances and other patients can be given for long periods of time without the toxicity seen with IV amphotericin, which is exactly what necessitates a change in therapy. So, we’ll see how that dialogue goes with FDA, but that’s — this is the unique position that MAT2203 is in. And what we really bring to the table here is that safety element and allowing amphotericin B to be used for long periods of time. That’s the goal. And ideally, you wouldn’t change the control arm at all. We don’t have to. And that’s why we think a composite superiority endpoint is really a significant step forward for the program. And then in terms of the market, you’re looking at here an orphan population in and of itself with invasive aspergillosis.
We’re targeting initially patients with limited treatment options. There are about 15,000 to 16,000 patients annually in the US that are invasive aspergillosis patients. About a third of those would fall into the category of patients with limited treatment options, meaning that they can’t — they’re resistant to azole therapy. They can’t take azole because of drug-to-drug interaction with other medications that they’re taking that happens a lot in the cancer arena. And so the value of that population right now is the fact that it’s orphan and they have no other alternatives. So, you are looking at an opportunity where if you layer on some of the pharmacoeconomic impact that we believe we can bring in getting patients out of the hospital in treating their fungal infections, it becomes a significant opportunity.
We estimate conservatively with the help of outside groups that, that could be a $300 million market alone in the US just for that limited patient population. A lot of that is — will be dependent upon the data we see in Phase 3 and discussions with payers. But that’s where the match up of an orphan patient population and a superiority endpoint, which you haven’t seen recently in these antifungal trials, is really the ideal set of circumstances to then have pretty productive discussions with payers, where in this patient population, they’re typically not going to get in the way of the infectious disease doctors desire to treat these patients and save their lives. So, we think it’s a big commercial opportunity for this indication alone. And then remember, this is a pipeline and a product.
And there is an opportunity with the pharmacodynamic bridge established by this Phase 3 program to quickly move into other invasive fungal infections with limited clinical trials necessary. So, it’s important that you start with a strong foundation, and that’s why we’re so excited by what Dr. Matkovits and her team have been able to achieve so far with FDA. We have a little bit further to go to finalize that endpoint, but obviously, a big change from non-inferiority to superiority.
Julian Harrison: Okay. Excellent. Very helpful. And then one final question, if I may, the potential LPAD designation. I’m wondering how soon that might be confirmed? Is that something you expect clarity on or around regulatory submission or perhaps earlier?
