Newron reports striking one-year interim efficacy results evaluating evenamide

Italian central nervous system (CNS) specialist Newron Pharmaceuticals (SIX: NWRN) saw its shares leap more than 17% to 5.12 Swiss francs this morning, after it announced what it called ‘very exciting’ results for its antipsychotic candidate evenamide.

Newron released new results from the first 100 randomized patients who have completed one year (52 weeks) of treatment in its international, randomized, open label, rater-blinded study of evenamide (study 014/015) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication. Results from these same 100 patients at six weeks and six months in study 014/015 have been reported previously.

Analysts at Edison Investment Research view the results in this update as particularly positive for the outlook of evenamide as an effective treatment for TRS, representing a significant catalyst in our opinion. Based on these encouraging results, Newron plans to initiate a potentially pivotal, placebo-controlled Phase III trial in patients with TRS (study 003) in 2023.