Newron Pharmaceuticals S.p.A., a research and development company focused on novel CNS and pain therapies, has announced the completion of the first in man US Phase I study of its novel sodium channel blocker NW-3509. NW-3509 is an orally available NCE that specifically targets voltage-gated sodium channels. It modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. NW-3509 normalizes glutamate release induced by aberrant sodium channel activity.
The Phase I study performed in 54 healthy subjects in six independent cohorts (nine subjects each) who received single doses of NW-3509 ranging from 1-30 mg, or placebo (2:1), was overseen by an Independent Safety Monitoring Board who reviewed all safety, tolerability and plasma level data at each dose level prior to recommending administration of higher doses. Newron plans to perform a double-blind, placebo-controlled randomized Phase II trial of NW-3509 as add-on treatment in schizophrenic patients on stable and adequate doses of atypical antipsychotics, whose symptoms are not effectively controlled by their medication. This 4-week study of the safety and preliminary evidence of efficacy of NW-3509 will be performed internationally and is expected to start in Q2 2015.
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.
Moreover, given its neuronal stabilization properties, NW-3509 may reduce relapses and prevent or treat episodes of psychosis due to established super-sensitivity psychosis (SSP) induced by antipsychotics. It may also benefit domains of symptoms such as cognition, mood disorders and suicidality that are currently not managed effectively by available treatments.
Source: Adapted by MNT from original media release
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