Newron’s evenamide study met its primary endpoint by showing improvement in both positive and negative symptoms, as well as severity in patients with treatment-resistant schizophrenia. Image Credit: Lightspring / Shutterstock.

Italian biopharma Newron Pharmaceuticals’s add-on schizophrenia treatment, evenamide, has met primary and secondary endpoints in a Phase II/III trial.

The placebo-controlled Phase II/III study (EudraCT Number: 2020-006062-36) evaluated evenamide as an add-on therapy with a second-generation antipsychotic including clozapine in 291 patients with chronic schizophrenia.

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The trial met its primary endpoint by showing an improvement in the symptom severity, measured using the Positive and Negative Syndrome Scale (PANSS) Total Score. The therapy also demonstrated improvement in the Clinical Global Impression of Severity (CGI-S), a secondary endpoint.

Evenamide had a favourable safety and tolerability profile, with 25% of the participants experiencing at least one adverse event. However, three participants discontinued the trial due to adverse events, two who were in the treatment group and one in the placebo group who died during the trial. Commonly observed evenamide-related adverse events were headache, vomiting and nasopharyngitis.

Following the release of the topline results, Newron’s stock price was up by 17.8% at market open on 30 April, compared to market close on the previous day. The company said it is also planning a “potentially pivotal” placebo-controlled Phase III trial evaluating evenamide as an add-on treatment in patients with treatment-resistant schizophrenia.

Various companies have invested in developing therapies for schizophrenia. One of the most anticipated therapies in the field is Karuna Therapeutics’ KarXT (xanomeline-trospium), which is a dual M1/M4 muscarinic agonist that could reduce both positive and negative symptoms of the neurological disorder. The Prescription Drug User Fee Act (PDUFA) date for KarXT is 26 September 2024. If approved, the drug would represent a new class of medication on offer to those with schizophrenia.

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Some companies have also faced setbacks in their development for the treatment of schizophrenia. In March 2024, Acadia Pharmaceuticals’ schizophrenia therapy, pimavanserin, failed to meet the primary endpoint in its Phase III ADVANCE-2 clinical trial. The company shut down the programme, stating that it does not intend to conduct any further clinical trials with pimavanserin.

Last month, the US Food and Drug Administration placed a clinical hold on the Phase I trial of Neumora Therapeutics’ schizophrenia therapy, NMRA-266. The decision was based on the preclinical data for NMRA-266, showing that the drug triggered convulsions in rabbits.