Pumped by an early glimpse of efficacy, Newron charts a pivotal course for schizophrenia drug
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.
It’s important to note that Newron and Anand decided to amp up the study so they could go beyond the safety data they were originally looking for — the drug proved tolerable, they say — and start to see how this therapy could work as an add-on.
The company recruited 89 schizophrenia patients with breakthrough psychotic symptoms while being treated with risperidone or aripiprazole.
“Compound A or B have the same characteristics,” says Anand. “All of them work to a certain extent.”
The two main therapies in use for schizophrenia do essentially the same thing, Anand tells me. And the results are frequently the same as well. Patients often respond initially and then switch after the response winds down. And then the response winds down again.
In a wide range of animal tests, he adds, evenamide appeared limited to sodium channel blockage and glutamate release, which is what they were looking for as a sign of its on-target specificity, reducing the odds of an off-target hit.
While the placebo response may look large to the uninitiated, Anand says it’s actually low. That’s because researchers specifically looked for patients with a constrained level of symptoms. In the pivotal trials to come, he says, they’ll be looking for patients experiencing elevated symptoms of schizophrenia, where the drug’s impact could be more clearly distinguished from a placebo. And if it works in the next trial involving about 360 patients, to get started next year, he believes it will be straightforward to replicate the results in a second confirmatory trial required by the FDA.
Anand adds that the drug’s “effect appears much better in younger patients.” That’s because “older patients have lost the capacity to respond. The disease destroys cognition” and as patients age, there are neurochemical changes in the brain due to their long running use of anti-psychotics that make their response to an add-on like evenamide less likely.