Newron Pharmaceuticals’ add-on schizophrenia treatment improved both positive and negative symptoms as well as severity in patients with the disorder during a phase 2/3 study.
The Italian biotech is trying to bring forward the first schizophrenia treatment in decades with evenamide, which could be combined with standard of care like clozapine for patients with chronic disease who do not respond to other treatments.
The trial met the main goal of showing improvement on a scale of positive and negative schizophrenia symptoms called the Positive and Negative Syndrome Scale (PANSS), according to a Tuesday release. Positive symptoms include delusions, hallucinations, excitement and grandiosity, while negative symptoms are emotional and social withdrawal, difficulty in abstract thinking and blunted affect. Patients who took evenamide also saw an improvement in the severity of their condition, which was a key secondary endpoint.
The four-week Study 008A was conducted at 45 centers in 11 countries, with 291 patients receiving either the study drug or placebo in addition to their current antipsychotic therapy.
Three patients discontinued due to adverse events, including two who were on evenamide and one on placebo who died during the trial. Overall, there were no safety flags discovered during the trial and no difference between the rate of central nervous system, gastrointestinal or other adverse events in the evenamide or placebo groups.
Newron called the main endpoint results “highly statistically significant,” with patients on evenamide seeing a 10.2-point reduction on the PANSS scale at Day 29, compared to 7.6 for the placebo group.
Shares of Newron rose 11% on the Swiss markets to 8.50 Swiss francs ($9.29), compared to 7.64 Swiss francs ($8.35), as of 2:59 p.m. CEST (8:59 a.m. ET).
Last year, Newron reported that the effect of evenamide increased between six months and one year. After one year, the biotech reported a more than 50% increase in the six-week change on the PANSS symptom scale. A 30% change was seen after six months.
Newron plans to disclose more from the study in the coming weeks. The company also hopes to use the data to make the case for a "potentially pivotal" phase 3 trial testing evenamide over one year in patients with treatment-resistant schizophrenia.