Highlights

It’s probably less of a pressing issue, but it’s certainly getting a lot of attention, so there’s a couple of things that are looking good in the negative symptoms area. One is a drug from Minerva, they failed in their – they didn’t separate from placebo in their Phase III trial, but they’re still negotiating with the US FDA about their drug. They had a site that clearly generated 100% fraudulent data, and if they delete that site from their Phase III trial, the drug separates from placebo just like it did in their Phase II study, that’s a drug that was used as monotherapy for people with minimal psychotic symptoms and negative symptoms, it’s a 5-HT2A sigma receptor agonist, so it is very similar to pimavanserin.

Well, I think that the combination of negative symptoms and cognitive impairments are a joined pressing unmet need, it looks like from observational research in very large-scale studies done by us, and by people in Italy, that negative symptoms have a greater adverse impact on social outcomes, and cognitive impairments have a greater adverse impact on independent living and productive vocational outcomes. So, clearly, they both represent independent treatment targets for different aspects of functioning, both of which are considerably impaired in people with schizophrenia. People have started to realize that cognitive impairment disability is also a major unmet need in bipolar disorder, and in bipolar disorder it looks like dysthymic symptoms and cognitive impairments combined together to lead to bad functional outcomes.