Newron Pharmaceuticals - Evenamide notches up another win (study 008A)

Newron Pharmaceuticals has shared positive top-line data for its evenamide programme from its potentially pivotal Phase II/III trial (study 008A) in patients with poorly managed schizophrenia on current antipsychotic therapy, but not considered treatment-resistant. The trial met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) score from baseline, and the key secondary endpoint of improvement on the Clinical Global Impression of Severity (CGI-S) scale. Statistical significance was met in both, consolidating the already strong results from the Phase II trial (study 014/015) in treatment-resistant schizophrenia (TRS). Management plans to follow this up with a potentially pivotal Phase III study in TRS (study 017), which, subject to final agreement by potential partners and regulatory bodies, could commence within 2024.