Greg Duncan: The sample sizes in the forward double-blind on COVID program will be a little bit larger. That is specifically a goal. I think we will also ensure patients have a diagnosis of COVID that precedes long COVID. That is consistent with other programs that FDA has endorsed less to moving forward. If you look at some of the other long COVID related research history, they want to confirmed diagnosis. But suffice it to say, we’ll be using the same dose, the same center. We’ll have a broader catchment area to recruit this program, but this program will actually be a little bit larger, but will benefit from more bells and whistles relative to advertising, social media outreach, et cetera, to potentially accelerate recruitment in that particular trial.
Sean Lee: I see. Great. That sounds very exciting and definitely looking forward to the results of this next one. My second question is on the proposed fibromyalgia. I may have missed it in the prepared remarks, but the PK study that started later this year. What’s the size and expected duration?
Greg Duncan: So the actual study itself only takes two to three weeks to run at a Phase 1 center. The size will be probably 20-ish patients per arm, 15 to 20 patients per arm. And effectively, what you’re studying is the levels of the combination product versus the independent components. And so it’s a relatively efficient study to run. Our goal is to actually commence that study this year to be ready to begin outreach on the more formal Phase III program, the head-to-head study is the one we’re going to start with in the Phase III program as we turn into 2024.
Sean Lee: Great. That’s what I need to know. Thanks again for taking my questions.
Greg Duncan: Of course. Thank you very much again, Sean, for interest in Virios and for participating on today’s call. It looks like…
Operator: Over to you, Mr. Duncan for final remarks.
Greg Duncan: Thank you, sir. So in summary, the team and I are really very encouraged about the potential to expand our pipeline and progress IMC-1 into Phase III development as a treatment for fibromyalgia and now IMC-2 into Phase II development as a possible treatment for long COVID. In short, we’re now complementing with fibromyalgia program with a very robust long COVID program, which has very significant commercial potential on its own merits. This year, more specifically, our goal is to initiate the IMC-1 pharmacokinetic and food effect study, as I just referenced in the Q&A. Later this year using the dosing formulation we plan to progress into both Phase III and into commercial scale up, presenting success in Phase III.
And at the same time, we’ll be submitting the final outline and the study protocols for final FDA blessing. We have time to do that without delaying the start to the Phase III program as we run the PK and Phase III study. As Mike shared, we are extraordinarily encouraged by the clinically and statistically significant improvements in fatigue, pain and symptoms of automatic dysfunction. That were observed in a long COVID study. As you can see in the popular press, COVID is not going away. It is here to stay. And if you think about orthostatic hypertension in the population that’s most at risk for both COVID and non-COVID, a fall could lead to hip fracture and a whole series of very significant health consequences. So getting it right for these patients with long COVID controlling their fatigue, controlling their autonomic dysfunction could be a very, very significant upgrade in the standard of care and health for these particular patients.
