We think, again, that it also has the ability with neurocircuitry that’s associated with temperature to be able to reduce the daily number of hot flashes that – just as we saw in the Phase 2a study but also the severity of those hot flashes and the types of things that disrupt lives, so sweating and function and the like. So it’s exciting that the challenge with that one is, like PH10, we’ve got to go through what probably will be about a 12 to 15 months IND-enabling program, where we do the CMC work and the preclinical work that’s needed to get back into a Phase 2b setting. The difference with this one is that there is a – there were – there was a prior U.S. IND. So we don’t think we need to do a Phase 1 study in order to get into Phase 2b for this indication.
So will be – it’s not a long – it’s not a lot of money, less than $2 million for these IND-enabling programs. We have to do similar work with PH15 and PH284, the other two pherine assets in the pipeline. So that’s the status of both.
Joanne Lee: Got it. Thank you for all the additional details. Once again, congratulations and looking forward to more updates this year.
Shawn Singh: Thanks, Joanne.
Operator: And our next question is a follow-up from the line of Andrew Tsai with Jefferies. Andrew, your line is live. Please proceed with your question.
Andrew Tsai: Thank you. Just a couple of more questions. Thank you so much for the time. I mean going back to PALISADE-2, there does seem to be a consistent efficacy signal across various end points. So I just wanted to make sure, were there other prespecified efficacy measures part of the study? And if so, how did those look? Just wanted to make sure all pre-specified measures are separated from placebo in a stat sig manner. Thanks.
Shawn Singh: Sorry, Andrew. Were – you asked if there is a separation against placebo across all the end points. Yes, there was one secondary – the primary, one secondary and two exploratories, and we reported on all those, so four total.
Andrew Tsai: Okay. Great. And going to the label – the eventual label, if both PALISADE and FEARLESS succeeded, what would your eventual label look like for SAD? And would there be precedents around that label claim? Thank you.
Shawn Singh: No, there is no precedent for the acute treatment for social anxiety disorder. We would be the first to blaze that trail with fasedienol. Drugs are used. Benzodiazepines, for example, try to achieve that but with considerable risk of abuse and misuse and addiction. But they’re never – they’re not approved for the treatment of social anxiety disorder. So only the three antidepressants: two SSRIs and one wellness, and they are approved for the chronic condition. There likely would be no limit, in our opinion, on how frequently somebody could use the drug acutely if it’s PALISADE-2 plus PALISADE-3 that supports the label initially. If it’s later, eventually, FEARLESS came along and the staggered starts, which we – is what we anticipate with PALISADE-3 first and FEARLESS second sometime in ’24.
It would be a case where the drug would be used acutely as needed but over time. And what you’d try to achieve for someone ultimately at the end of the day is they wouldn’t have to take the drug. That’s often and hopefully still also combined with talk therapy. So yes, the PALISADE-2 hits the acute side of that match set. FEARLESS would hit the over time, although certainly, people wouldn’t be precluded from using fasedienol over time if what’s achieved is only the acute label.
Andrew Tsai: Got it. And really quickly, as we think about the NDA package in the future, any peripheral studies that you would need to do such as, I guess, repeat – just multiple dosing per day kind of studies, for instance? Thank you.
