I mean, obviously we have seen that for the clinical trials, it does make a difference whether you include fever in your primary endpoint. It also is really important how much time elapses between someone being dosed and someone being infected. So these are of course very important learnings for us. And we are of course continuing to analyze the data and grasp as much learnings as we can for our next steps. And maybe, Phil, you can talk a little bit more about all the data analysis that is ongoing and that we are planning to learn more about by beginning of next year?
Phil Pang: So Nick, one of the critical questions that always exists regardless of the space and especially it’s true for infectious disease is how does your in vitro or in vivo results translate into the clinic. And so one of the critical questions in addition to all the lessons that Marianne pointed out is how do we calibrate dose between in vivo findings and clinical efficacy. So one of the advantages of having really been the first company to ever run a prophylactic outpatient flu trial is we now will and soon will have the data that really calibrates PK to PD, as I mentioned in my — as I may have mentioned previously, which allows us to really understand the dose and concentration that is necessary and translate in vitro and in vivo findings to people.
And so that will be very useful part of our 2981 development in addition to what Marianne mentioned about clinical endpoints and timing is really trying to calibrate that bridge that gap and using 2482 to help inform 2981. And we’re already planning a series of studies to make sure that that gap is as small as possible.
Nik Gasic: So thinking about this future trial design. Would you consider using the WHO and CDC endpoint — WHO and/or CDC endpoints as your primary, I guess, future trials in flu? How should we think about that since they both feature fever?
Phil Pang: So I think we maybe even a little bit more advanced beyond that. We are basically certainly recognizing that fever is an important — or temperature, if you would. Now they do have a slightly different temperature between the CDC and the WHO, 37.8 versus 38.0 degrees Celsius. So we are looking into that as well as any other symptoms that are well covered by 2482 in post-hoc analysis. So we’re going to put all that together to decide. But certainly, fever will be a part of what we consider moving forward.
Operator: Your next question will come from the line of Eva Privitera with TD Cowen.
Eva Privitera: We have one on the SOLSTICE trial with data at AASLD. Approximately how many patients worth of data should we expect, and are each treatment groups pretty balanced? And what efficacy measures do you expect to report in addition to the primary endpoint?
Marianne De Backer: I will just say that obviously this will be the very first time that we show really very initial data also from our SOLSTICE this trial. So as Phil mentioned in this prepared remarks, this is still with a small number of participants in each of the arms. But we will see some initial data on, of course, 2218 alone, 3434 alone, and then the combination. Anything to add there, Phil?
Phil Pang: No, I don’t think. And maybe I’ll just clarify a couple of things that essentially we are going to be looking at, as Maryanne pointed out, the monotherapy and the combination therapy. And the way in which the study is designed is we enrolled a very small number of patients in those monotherapy arms. And then if they — it showed signs of antiviral activity or didn’t show signs of anti antiviral activity, they would or would not roll into a combination treatment arm to be able to really understand how the two drugs work together or don’t work together. So that’s going to be the design of the trial and we look forward to sharing data at AASLD.
