That was the primary efficacy end point. We needed to make sure, and we did find this out in the first quarter that the FDA still believed that to be a valid and reliable end point and they do. So that provides optionality there. The other side is, well, we already know what they think about the SUDS end point and the PALISADE program. Importantly, too, we have a keen interest given that social anxiety disorders, normally the onset is typically in adolescence between, say, ages 8 and 17. There’s a huge number, as we know, of minors who are affected with mental health disorders, especially social anxiety disorder. The Liebowitz Scale, there’s an LSAS-CA, which is for children and adolescents, so much easier down the road when we want to extend our treatment opportunity to pediatrics to run a Liebowitz scale-based study using a modified version of that scale similar to the way that the adult study was run.
Difficult to envision a 10-year-old giving a public speech to a group of strangers, just much easier to execute down the road in a pediatric setting as well. So it’s really a nice combined set, either one of the 2. Ideally, we see both. And then you have a very robust commercial opportunity that extends into the pediatric arena.
Joanne Lee: Got it. That was really helpful. And clearly, lots of excitement around the SAD program, but we’re also really enthusiastic about the broader pherine platform as well. Could you shed some color on the current statuses and progress of those programs, PH10, 15 and 80, particularly on the latter, PH80, with the positive preclinical data? We see the hot flashing, other symptoms in menopause receiving a lot of – a lot more attention in the area of women’s health. So curious if you could walk us through some of the time lines around those programs.
Shawn Singh: Sure. Well, first, with respect to itruvone, or PH10, that’s now, after a bit of a long run, it’s staged to go into Phase 2b development in the U.S. Those – the efficacy study was run outside the U.S. And so we really had to start back to the point of the U.S. IND-enabling program. For that one, because there had been no prior U.S. activity or no prior U.S. IND, we did the whole standard battery of nonclinical studies followed by a small Phase 1 to then now be able to leap back over, we believe, the Phase 2a that was done and move into Phase 2b, so tremendously exciting program given what we just also learned that, like 94B or fasedienol, there’s no meaningful systemic exposure. And the kinds of safety profile benefits that we see from fasedienol are also in the itruvone zone, meaning that we didn’t – we don’t anticipate sexual side effects.
We don’t anticipate weight gain. We don’t anticipate many of the types of side effects and safety concerns that are associated with the currently approved systemic therapy. So very excited about that as the stand-alone treatment for major depressive disorder. As to PH80, again, you hit it. Hot flashes is hot right now. With the new NK3 antagonist that was approved, there’s been a lot more interest of late in that space. There’s an enormous population course that’s affected by hot flashes for many years with very limited options that don’t cause some concern, whether it’s hormonal therapy or the new class. PH80 is majorly distinguished from both of those current treatment options and the antidepressants that are used for hot flashes because, again, like fasedienol and itruvone, we don’t believe it’s systemically absorbed.
