Dr. Zamaneh Mikhak: That’s a good question, too. The 40-patient trial was the original design of this study really did not take into account the indication IPA is a rare disease. You do a 40-patient Phase 2 study, for example, in rheumatoid arthritis, if you’re doing a sort of a regular pack or you do it in psoriasis, big common, big footprint disease. In rare diseases, generally, you look for a smaller sample size in your trials because there are just fewer patients in these trials. For example, IPA, the number of patients with new diagnosis of IP worldwide is 80,000 patients. So, that’s a quite a rare of disease. So the way one does clinical development in a rare disease indication is that you look for more telling signals of efficacy, and that helps you have a smaller sample size.
We also have the luxury that the drugs we’re developing are first-line approved drugs, the chemical entities are not new. So, we know what voriconazole can do. We know what tacrolimus can do. We understand their efficacy profile. We understand their safety and tolerability profile. So, we don’t think you need 40 patients to be able to make a call as to how TFF VORI is doing compared to oral voriconazole. I’ll give you an example. With oral voriconazole, about 15% to 20% of patients have to decrease their dose or actually eventually go off therapy because of liver toxicity. That’s a really high rate of liver toxicity, and that’s very well known, very common experience. In our clinical trials, we have not seen any patients so far between the healthy volunteers, between patients with mild asthma, between the patients we’ve had in compassionate use, between the patients we’ve had so far in our clinical trial, nobody with liver toxicity.
So, we don’t think you’re going to need 40 patients to be able to make this call. The difference will be large enough that you’ll be able to make it call the just 10 patients. So it’s really an adjustment in clinical trial design to match the indication a little bit better?
Jonathan Aschoff: Okay. So you will make that decision on 10 patients versus 10 doesn’t quite look compelling, hey, let’s enroll more. Like, what do you think you’re more likely to do, just make that call, or if that’s not clearly a yes, try for some more patients to see if it gets to a yes?
Dr. Zamaneh Mikhak: We’ve always said it’s approximately 10 patients. But bottom line is that we don’t think you need a lot more than that. Obviously, you have to look at your data, make decisions accordingly, but we don’t think it will be — you need the original design, which was comparing 20 patients getting TFF VORI with 20 patients, getting oral voriconazole, then making a call. We think we’ll be able to really rely and draw on the experience that the knowledge that’s there about oral voriconazole. And also, you would need fewer patients than 20 to make a call about TFF VORI.
Jonathan Aschoff: Okay. And I’m not to leave Kirk out. Kirk, there were sequential decreases, which is good in R&D and SG&A for the first and the second quarter. Are you at a cruising altitude, or do you expect that to continue dropping a little?
Kirk Coleman: That’s a great question, Jonathan. Thank you. I think we are starting to settle in and the guidance we are giving obviously is we are anticipating that our burn rate is about $4 million a quarter, and then we’ve got enough runway to get us through into — through Q1 of 2024.
Jonathan Aschoff: I’ve got you there easily. Okay. Thank you very much.
Operator: Thank you. The next question comes from Justin Walsh of JonesTrading. Please go ahead.
Justin Walsh: Can you expand on the criteria you expect to use for your go/no-go decisions? Like, what type of results would you need to see to give you confidence that it warrants advancing into Phase 3 for your asset?
