David Bautz: Okay. That makes sense. And then just how long is that study going to take? What are the outcomes for the food effect study, those types of things?
Greg Duncan: Yes. I was going to go on to that. I just want to make sure I answered your first one. So the two things we’re studying in this pharmacokinetic study using the new formulation are both total exposure as measured by classic area under the curve, how much exposure is there from the new dosage compared to the reference doses, as well as what is the Cmax or the maximum blood concentration, which usually occurs shortly after administration of the drug. So, what we want to make sure is that the Cmax maximum exposure and the total exposure over dosing period at steady state or consistent with the dosage levels for the independent components, that’s famciclovir and celecoxib. And by doing so, we can utilize all of the safety longer-term studies that were used to originally approved both famciclovir and celecoxib and avoid doing all those other ancillary studies.
So we can have a very efficient Phase 3, which is too adequate and well-controlled trials and patients from those trials can be rolled into a long-term extension. That gives us the most efficient way to progress this Phase 3, which is good news for obviously Virios shareholders and ideally patients moving forward.
David Bautz: Okay. And lastly, about Long COVID, I’m curious if you could talk about why you decided to do another single center study with the Bateman Horne Center as opposed to kind of expanding out and doing a larger double-blind, placebo-controlled study at this time?
Greg Duncan: Very good question, David. So the shorter answer is we’re doing both. I think you’d agree, I mean, you look — need to look no further than today’s headlines. COVID’s here to stay. And so we are commencing the double-blind, placebo-controlled IMC 2 program in long COVID, which is fully funded. It doesn’t require us to raise additional capital. This is a very efficient progression. So we can now study IMC-1 under classic double-blind, placebo controlled conditions. Simultaneously, and I say this with great hopes moving forward, we are engaging with an NIH, who you’re very familiar with, but also the NHLBI, which is working with NIH, the NHLBI is the National Heart, Lung, and Blood Institute for those that are not familiar.
Those two academic institutions are actually evaluating and administering the funds that NIH really recently allocated to research in non-COVID and they’re evaluating different options moving forward. We’ve engaged with them. We have some meetings set-up this fall to talk with them about the study that Mike provided the top line highlights with all of which is to say we’re looking to see if we can’t secure some non-dilutive funding options for the broader Phase 2 dose-ranging study that is the next step in the more classic development process. So it’s really two shots on goal here. We will provide updates on the progress on both as we get into fall and close in on the end of the year. But suffice it to say, hopefully, you can get a sense, David, that if you were excited about fibromyalgia, which we all are, obviously, anybody on the call is, we now have a second program as a complement to the fibromyalgia program, and we’re leaving no stone unturned we’d like to progress the confirmatory trial and see if we can secure either partnership or non-dilutive funding to progress the more classic Phase 2b dose-ranging study.
So really two shots on goal with that. And as Mike mentioned earlier, what we’re really excited about here for IMC-2 is having filled this provisional patent. If that patent is granted, that will extend our intellectual property protection — out to roughly 2044. So long lead time on that method of use patent to be able to research and progress the long COVID program as a complement to fibromyalgia.
David Bautz: And so Virios is sponsoring this study at the Bateman Horne Center, is that correct?
