Newron's shares accelerate as one-year schizophrenia data boost chances of historic approval

Newron Pharmaceuticals has reported deepening responses to its add-on schizophrenia therapy out to one year, triggering a further stock boost as investors reassessed the likelihood of evenamide becoming the first approval in treatment-resistant disease since 1989. 

Progress in the pharmacological management of treatment-resistant schizophrenia has stalled since the FDA approved clozapine in 1989. Newron thinks evenamide can buck the trend by selectively blocking native sodium channels and inhibiting the release of glutamate. Last month, the release of six-month data from a phase 2 trial provided early validation of evenamide.

Newron’s stock has also been bucking industry trends in 2023, up 175% since the start of the year.

Now, the Milan-based drug developer has shared one-year data from the study. Newron presented data on a set of efficacy measures that suggest the effect of evenamide increased between six months and one year, continuing the trend seen between six weeks and six months.

After one year, the biotech reported a more than a 50% increase in the six-week change on the PANSS symptom scale. A 30% change was seen after six months. The increases happened over a period in which the number of participants included in the analysis fell, from 97 after six weeks to 85 after six months and to 77 after one year, because people dropped out of the study.

Newron also reported increases in the proportion of patients who had a 20% or greater improvement on PANSS, its threshold for a clinically meaningful change, and continued reductions on a severity of illness scale. Manhattan Psychiatric Center’s Jean-Pierre Lindenmayer, M.D., called the results “very promising” in the release.

“The pattern of improvement is particularly unusual as it occurs gradually over a year and is sustained,” Lindenmayer said. “We rarely see such a pattern of improvement with current treatments. In addition, the mechanism of action of evenamide appears to be completely novel.”

The release of one-year data from the trial triggered another jump in Newron’s stock on the Swiss exchange Thursday, bringing it up toward 5 Swiss francs ($5.40). But with a market cap 81 million francs, Newron remains a small player. That could change if the biotech confirms the results in larger trials. A phase 3 study in treatment-resistant schizophrenia is scheduled to start this year, with data from an ongoing phase 2/3 trial also due this year.