Newron Pharmaceuticals - Evenamide road to registration and beyond
Newron hosted an investor day (25 June) featuring three key opinion leaders (KOLs) who highlighted evenamide’s unique mechanism at the site of pathology, offering durable responses and addressing unmet need despite the >40 available treatments for schizophrenia. Evenamide has a robust track record in clinical studies to date. Notably, the results of study 015 in treatment-resistant schizophrenia (TRS) saw 25% of patients achieve remission, and, more recently, the results from study 008A (poorly managed schizophrenia) confirmed the safety of evenamide as an add-on to current antipsychotics, as well as its effectiveness in a randomised, placebo-controlled setting. The KOLs commented on the potential benefit from earlier use of evenamide in patients with inadequate responses to current treatments. The reported data to date provide a strong foundation in addressing schizophrenia, in our view. Newron will prepare for the registrational trial (study 017), which, subject to securing a partnership deal, could launch by end-2024.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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