Newron Pharmaceuticals - TRS data green-lights evenamide Phase III plans
Newron has announced positive 12-month data from its Phase II extension trial (study 015) assessing evenamide in 161 patients with treatment-resistant schizophrenia (TRS). The results demonstrate desirable safety and tolerability, as well as durable efficacy of evenamide, showing statistically significant improvements (p-value <0.001) in all key efficacy measures (PANSS, CGI-S and LOF) versus baseline. We believe the results are favourable for Newron’s TRS programme and bolster the company’s plans to launch a potentially pivotal Phase III trial, which management expects to commence in Q224. We note that the company is also gearing up to share results from the Phase III trial (study 008A) for patients with poorly managed schizophrenia in March 2024, which could represent another significant catalyst for investor attention.Newron Pharmaceuticals is a clinical stage biopharmaceutical company. Co. is focused on the development of drugs for the treatment of central nervous system disorders and pain. Co.'s pipeline include, Xadago® (safinamide), for the treatment of Parkinson's disease (PD) and PD Levodopa-induced dyskinesia; Sarizotan, for the treatment of Rett syndrome (Orphan drug status); Evenamide (NW-3509), for the treatment of Schizophrenia and Clozapine-treatment-resistant schizophrenia; and Ralfinamide for patients with specific rare pain indications (neuropathic pain).
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