Newron Pharmaceuticals - Gate not yet open to Phase III
Newron is developing evenamide as an add-on to existing anti-psychotic therapies to treat poorly managed and refractory schizophrenia. Two recently completed safety studies, one in patients and the other in healthy volunteers respectively showed no brain or heart safety issues. The patient Phase II study did not show efficacy at the 7.5mg or 15mg bid doses requested by the FDA. Newron will now complete the requested safety work using the intended therapeutic dose of 30mg bid. This continuation study (008A) will take until H221 to complete. Our indicative value of CHF121m has been retained until Study 008A completes.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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