Date: 2015-12-02
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Newron Pharmaceuticals (Italy)
Product: NW-3509
Action
mechanism: sodium channel inhibitor/sodium channel blocker. NW-3509 is a voltage gated sodium channel (VGSC) inhibitor, originated from Newron’s Ion Channel program. It modulates neuronal hyper-excitability, and is active in a broad range of animal models of psychosis, mania, anxiety, cognition and depression. NW-3509 normalizes glutamate release induced by aberrant sodium channel activity.
The potential benefits of NW-3509 have been demonstrated in extensive animal models predictive of efficacy in psychiatric diseases, including models of psychosis and schizophrenia, such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression. Efficacy of NW-3509 has also been demonstrated in models of aggression and compulsive behavior, as well as in short- and long-term memory tests. Sub-threshold doses of NW-3509 increased the activity of inactive doses of both typical and atypical antipsychotics in models of schizophrenia, psychosis and mania. Preclinical data indicate that NW-3509 may add to or synergize with antipsychotic drugs to produce a combined therapeutic effect by modulating glutamate and dopamine systems that have been associated with schizophrenia symptoms.
Disease: schizophrenia
Therapeutic area: CNS diseases - Mental diseases
Country: USA
Trial details:
Latest
news: * On December 2, 2015, Newron Pharmaceuticals announced the initiation of a U.S. Phase II study with its novel sodium channel blocker, NW-3509, in patients with schizophrenia. NW-3509 is an orally available new chemical entity that specifically targets voltage-gated sodium channels, acting with a unique mechanism of action. The Phase II trial is designed to investigate safety and preliminary evidence of efficacy in a double-blind, placebo-controlled randomized trial. NW-3509 will be administered as add-on treatment in schizophrenic patients experiencing break-through psychotic symptoms while on stable and adequate doses of their current atypical antipsychotics. The 4-week study will be performed in a minimum of 60 patients in two U.S. study centers. Patients will be treated twice daily with 5-25 mg/day of NW-3509, or placebo. The doses to be tested in this study in patients were found to be well-tolerated in healthy subjects and were associated with plasma levels that overlapped with exposure shown to be effective in preclinical models of psychosis. Doses and study design were finalized after receiving FDA input and guidance. Study results are expected to be available in Q4 2016.
