Just a few days after Newron finally landed an FDA approval for Parkinson’s add-on therapy Xadago after a 4-year regulatory odyssey, the biotech is back with a snapshot of early data on a new treatment for schizophrenia. And while they were able to pull out positive data from the Phase IIa study of evenamide, investigators plan to make some significant changes to the next study that could provide more plainly promising pivotal results.
Presenting at the 16th Congress on Schizophrenia Research in San Diego over the weekend, Newron concluded that their drug evenamide did help a large group of patients.
The mean change for the Positive and Negative Syndrome Scale (PANSS) score overall was -5.1 for the add-on compared to -3.7 for the placebo, which Newron Chief Medical Officer Ravi Anand described as “very close” to statistical significance. If you just looked at the positive side of the scale, he added, the results were statistically significant.
The article starts off great but if you notice in the final paragraph the head of Newron says that it was more useful in younger individuals than those who have been on antipsychotics for a while.
The disease destroys cognition and peoples neuro chemistry change as a result of the antipsychotics.
If that isn’t an argument for less meds or better drugs then I don’t know what is.
Anyway I’m looking forward to this drug because of its novel mechanism of action
Also remember this was a 4 week test. This guy is the lead doc; I have to assume he knows what he’s doing, so it’s sad to see that he doesn’t seem hopeful about its use in those with longstanding sz. But it’s always possible people with more longstanding disease will take longer to respond. 4 weeks ain’t much. If there was an extension phase longer than that, I missed reading about it.
I would really like to see this drug get approved as a mono therapy but I would settle for an adjunct with less antipsychotic. It’s supposed to be great for depression and mania too, both problems for me.
All around it just seems like the first real breakthrough drug in clinical trials.
I hope it does work on those of us who have been ill for a while. It’s been 16 years for me, I’d hate to think that my brain is fried, but who knows.
I don’t know if we can assume an AP with a novel action will work as fast as current APs. Perhaps it will. I also got the impression the doc was talking about the cognitive results in the longer term patients. Since there is a lack of treatments for cognitive issues, I’m also not sure that we can assume that cognitive issues will respond as quickly as positive symptoms since there’s not really been anything to study yet.
It’s not terribly encouraging but I don’t think it’s entirely definitive yet.