Thomas Yip: Understood. Thank you again for taking our questions. Looking forward to your updates in the next coming months.
David Luci: Very good. Well, thank you, Tom. Assume that and thanks to Ed as well.
Operator: Thank you. Our next question is from the line of James Molloy with Alliance Global Partners. Please go ahead.
James Molloy: Hi. Good morning. Thank you very much taking my questions. Could you walk us through a little bit, maybe a little competitive analysis where Summit their failure in ’21, but Dave said back in 11 (ph) obviously with the approval. Can you walk through a little bit to sort of the dosing, the reinfection rate what Summit did wrong with what Merck and Cubist did right on deficit and how that ties into ibezapolstat and what you guys are hoping to do here in your Phase III?
David Luci: Sure. The Merck example is the most clear example because they — Merck’s predecessor Optimer went to Phase III with 15 out of 16 cures in an open-label trial. We have 15 of 16 in IIb and another 10 of 10 in IIa. So we’re going at 25 of 26. So as Bob mentioned, it’s a robust package and is supplemented by our manufacturing, preclinical and other data. So we’re delighted with that and we’re following a successful pathway with the fidaxomicin pathway. What others have done wrong, so Summit Therapeutics, you mentioned, they conducted a superiority trial, as I understand it, and it wasn’t involved. But from what I gather from the public disclosure, they enrolled quite well through COVID at around 169 trial sites internationally.
And we like that model for our Phase III, which we expect to be international as well. And you can see their sites on clinicaltrial.gov. But they had a superiority trial. And while they are conducting that trial, Jim, they actually try — they changed their primary endpoint and unblinded the data and took a look. And only after that did they go to the FDA to try to get the FDA to kind of ratify what they did, and the FDA wasn’t comfortable with that. So I don’t know exactly how that series of decisions kind of happened. We didn’t do that. We contacted the FDA prior to ending the Phase IIb trial to make sure that everything was copacetic and they were very good at getting back to us quickly. And we also reached out and contacted our independent data monitoring committee and our Scientific Advisory Board to make sure that we are in unanimous agreement that this was the right decision.
And certainly, we think it was. So that’s kind of like an alternative to how Summit kind of ran their Phase III. So the thing about Summit’s Phase III that we like is the pace of their enrollment. I think they got about 750 patients internationally in about two years’ time. Our first study will be, I think, somewhere in the neighborhood of 200-ish.
James Molloy: Understood. And also, one of the — you talked about the healthy microbiome with the ibezapolstat, I know — again, not to pile on some of what, they are most recent relevant company to look at. They were talking about the microbiome and their data as well and obviously didn’t help them very much. How do you quantify sort of a healthy microbiome? And how much do you think that plays into the FDA’s decision vis-a-vis just really being noninferior to Banco?
David Luci: I think it’s a burgeoning fast-growing kind of business sector, the microbiome. And the reason why it’s so important is because when you have an imbalanced microbiome, just generally outside of C. diff, it leads to disease, whether it’s cancer or C. diff or diabetes, all kinds of things are triggered as we find more and more by an imbalanced microbiome. Now in terms of C. diff, the primary cause of reinfections is an imbalanced microbiome, right? And the C. diff reinfection market is best estimate $4.7 billion a year in the U.S. So if you can restore a healthy microbiome, you’re basically able to make a very nice dent in the public health cost in the recurrent C. Diff market. So we think that’s going to play an important role.
And it’s going to distinguish us from a broad spectrum antibiotic like oral vanc, which has — it just decimates the microbiome because it’s a broad spectrum. I think oral vanc was approved in 1986 to treat C. diff because there was so little out there that was useful to treat C. diff. It wasn’t that it was the best tool because it’s broad spectrum, not narrow spectrum, but there was just such a need that it got the approval and its first approval was in 1958. I hope that answers your question.
James Molloy: It does indeed. And just a couple of questions, if I could, please. Any updates on the PASTEUR Act?
David Luci: We haven’t had any updates on the PASTEUR Act specifically. We understand there’s a number of different legislative options out there that are being considered. But the more I watch Washington, the more I realize that I have no idea what’s going on. I mean, it looks like we’re coming up to another government shutdown. And I’m sure nobody is thinking ahead of the holidays. They’re trying to keep the government open right now.
James Molloy: Okay. Maybe just a last question for Robert. Keeping a close eye on the accrued expenses here in the third quarter. Can you walk us through what the 82% of the [indiscernible] vendor are on that, please?
David Luci: Rob, do you want to?
Robert Shawah: Yes, that’s our clinical research organization. Yes.
Robert DeLuccia: Our CRO, yes.
James Molloy: Great. Thanks for taking the questions.
David Luci: Thank you, Jim.
Operator: Thank you. Our next question is from the line of John Stinton (ph) an Investor. Please go ahead.
Unidentified Participant: Thank you for taking my questions.
David Luci: Good morning, John.
Unidentified Participant: Can you hear me now?
David Luci: Yes. I can hear you.
Unidentified Participant: Right. So with regard to the 94-day study, is it possible that, that study when fully digested will prove clinical superiority rather than non-inferiority?
David Luci: There will be numbers that people can interpret, but it won’t be statistically driven.
Robert DeLuccia: Correct. You’re right, Dave.
