Newron Pharmaceuticals has commenced a pivotal four-week clinical trial, Study 008A, assessing its orally available compound, evenamide, as an add-on treatment for schizophrenia.
A new chemical entity, evenamide selectively acts on voltage-gated sodium channels to treat the condition.
The drug’s mechanism of action involves glutamate modulation and voltage-gated sodium channel hindering. This glutamatergic inhibition provides a novel treatment option to patients who have no benefit from existing antipsychotic therapies.
The randomised, double-blind, placebo-controlled, global Study 008A will analyse the efficacy, tolerability and safety of the 30mg twice-daily therapeutic dose of evenamide in chronic schizophrenia patients.
It will include subjects who are already receiving a second-generation antipsychotic.
The impact of the drug on the electroencephalogram (EEG) will also be evaluated.
The company intends to enrol a minimum of 200 subjects at trial sites across Europe, Asia and Latin America.
The study is part of the company’s Phase III evenamide clinical trial programme in schizophrenia patients who experience psychosis worsening on receiving therapeutic doses of atypical antipsychotics and those unresponsive to treatment.
Newron anticipates data from the latest study in the fourth quarter of next year.
Newron Pharmaceuticals CMO Ravi Anand said: “If successful, Newron believes the study would qualify as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.
“Evenamide would currently be the first add-on therapy approved for the treatment of patients with positive symptoms of schizophrenia, and its unique glutamatergic inhibition mechanism of action offers a truly innovative therapeutic option to those patients who are not benefitting from their current antipsychotics.”
Evenamide showed efficacy in substantially improving psychosis symptoms versus placebo when given with two most commonly used atypical antipsychotics in a Phase IIa trial involving chronic schizophrenia patients.
Furthermore, the drug was demonstrated to be safe in trials involving more than 300 healthy subjects and patients at doses of up to 60mg.