Newron Pharmaceuticals has reported favourable results from a Phase IIa clinical trial of its evenamide (NW-3509)for treatment of patients with schizophrenia.
Evenamide is a new chemical entity designed to target and block voltage-gated sodium channels, as well as normalise glutamate release caused by abnormal sodium channel activity.
The results from the trial indicated that evenamide as an add-on therapy has met the study objectives of tolerability, safety and preliminary efficacy.
The four-week, double-blind, placebo-controlled, randomised, multi-national Phase IIa trial evaluated the objectives in 89 subjects with a DSM-5 diagnosis of schizophrenia.
Newron chief medical officer Ravi Anand said: "The results of this first study in patients with schizophrenia confirm preclinical data, which indicated that evenamide might provide significant evidence of efficacy as an add-on to the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia, without effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics."
Conducted at two US and three Indian sites, the trial involved patients with a mean duration of illness of around 18 years and an average of three hospitalisations.
The results showed that patients demonstrated improvement on the symptoms of schizophrenia measured by the positive and negative syndrome scale (PANSS).
Evenamide was also found to have potential benefits in preclinical models with psychiatric diseases, psychosis such as amphetamine-induced hyperactivity, sensorimotor gating and information processing deficits, as well as mania, depression, aggression and compulsive behaviour.