Minerva Neurosciences, Inc. - Special Call Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : Thanks very much for the very robust data presentation today. Really appreciate it. Just wanted to dig a little bit more into the PSP data. I'm aware that, that has 4 components, one of which is actually disturbing and aggressive behaviors. Was that actually measured? I didn't see the data in the presentation today. I ask because there seems to be a benefit on the Marder positive symptoms factor score that came out in this trial, and I'm wondering whether that was replicated in that component of the PSP? Philip D. Harvey;University of Miami Miller School of Medicine;Professor I looked at that data. And basically, the scores are extraordinarily low because people were selected for the absence of hostile and disruptive behavior when they entered the trial. So the positive symptom improvement is really -- very interesting because it's improvement from a baseline of a very low score at the beginning. So the actual prevalence of disruptive and aggressive behavior in this patient population was low based on selection criteria. So we don't really have a good way to know if that is one of the main benefits of this treatment. Because I think that with people selected for very low scores, changes can be statistical artifacts afterwards, such as regression to the mean and things like that. without the prior written consent of Thomson Reuters. 'Thomson Reuters' and the Thomson Reuters logo are registered trademarks of Thomson Reuters and its affiliated companies.

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : That makes perfect sense. What is, if you can, a clinically meaningful difference on the negative symptoms factor score, but specifically the emotional experience component that you've described. Is it kind of too early to tell? Do we need to dig more into the avolition type data here to understand that? Or are you willing to say that it's a good point? Philip D. Harvey;University of Miami Miller School of Medicine;Professor It's very -- it's challenging to say because people weren't selected specifically for that, but one would think that improvements in the same magnitude as the general level of responder improvements like 20% or more would be important. Keeping in mind that the PANSS is rated on a 7-point scale. So the smallest improvement that you can get is 1 point. So I think that it's a little early to say exactly what the significance would be, but we have shown in studies that we previously published that both low and high levels of reduced emotional experience still correlate with impairments and social outcomes. So improvements of 1 point -- 1 or 2 points on the overall scale actually are associated with significant differences in everyday functioning. These are not treatment data, but they're observational data. So people who have higher scores have worse social functioning, but even lower scores correlate with social impairments. So this reduced emotional experience, avolition type symptoms are important even at relatively mild levels because people who have mild levels of those symptoms, such as people with schizotypal personality disorder, still have very significant social deficits. Brian Kirkpatrick;University of Nevada Reno;Chair, Department of Psychiatry A couple of other quick thoughts. One of the things to keep in mind is that, ideally, if someone were to respond at all to this medication, you would also want to provide them with psychosocial interventions. And then you might see some synergy between those two things. It would affect size even more than just the sum of the two. The other thing is, Myles, I suppose we could -- it might be interesting to look at the correlation between changes in PSP score and change in the Marder 7 factors. And see is that linear? Or is there some sort of threshold?

Question: Myles Robert Minter - William Blair & Company L.L.C., Research Division - Analyst : A quick final one from me. And it's only a question that we asked from a regulatory perspective, but maybe to the experts that we've got on the phone. When you're looking at prescribing therapies, do you actually look at the patient data set and make a decision on I treat U.S. patients, so I need to see clinical data from U.S. patients versus European patients? Or are you just more care about the fact that it's shown an effect in the clinical trial. I only ask is I think there's -- and Remy, correct me if I'm wrong, there's like 16% of U.S. patients in this trial? Just wondering whether that influences prescribing dynamics, if it's approved?