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First Add-on Therapy for the Treatment of Schizophrenia with Encouraging Phase II a Data

Evenamide is an orally available New Chemical Entity that specifically targets voltage-gated sodium channels in development as add-on therapy for the treatment of schizophrenia. The compound originates from Newron’s ion channel program and has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. The potential benefits of the compound have been demonstrated in numerous preclinical models predictive of efficacy in psychiatric diseases, including models of psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits (pre-pulse inhibition impairment induced by different stimuli), mania and depression. Efficacy of Evenamide 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 the compound increased the activity of inactive doses of both typical and atypical antipsychotics in models of schizophrenia, psychosis and mania. Moreover, given its neuronal stabilization properties, Evenamide may reduce relapses and prevent or treat episodes of psychosis due to established super-sensitivity psychosis (SSP) induced by antipsychotics. As it is devoid of the risk of drug-induced movement disorders or weight gain, Evenamide can be given in combination for extended periods of time.

In 2017, Newron presented the results of a Phase IIa study with Evenamide at the 16th International Congress on Schizophrenia Research in San Diego as well as the 30th European College of Neuropsychopharmacology Congress. The study demonstrated evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. It also indicated that Evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics. These results, alongside earlier preclinical results, which indicated a glutamate antagonism mechanism of Evenamide, have been discussed with a number of health authorities and we have meetings planned with the EMA’s CHMP and the FDA in 2018.

Following these meetings, Newron plans to finalize the design of two potentially pivotal studies’ being key components of the Phase III development program that is expected to commence in QII 2019; one study will include patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and the other treatment-resistant patients not responding to the antipsychotic drug clozapine. It is estimated that this latter cohort consists of approximately 20,000 patients in the US and potentially provides a discrete Evenamide opportunity that Newron (or other mid-sized biopharma companies) could choose to commercialize directly.