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Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients 21.01.2021 / 07:02 The issuer is solely responsible for the content of this announcement.

Newron completes enrollment of explanatory safety and efficacy study with evenamide in schizophrenia patients

Final study data intended to support the initiation of Newron's planned phase III pivotal trial program for evenamide
 

Milan, Italy and Morristown, NJ, USA, January 21, 2021 - Newron Pharmaceuticals S.p.A. ("Newron") (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced the completion of enrollment for its explanatory study 008 with evenamide in patients with schizophrenia.

Results from the four-week, randomized, double-blind placebo-controlled study are expected in March 2021. Explanatory study 008 is designed to evaluate the safety, tolerability, EEG effects, and preliminary efficacy of two fixed doses of evenamide (7.5 mg and 15 mg BID) in outpatients with chronic schizophrenia receiving treatment with one of the leading second-generation atypical antipsychotics. Enrollment to the study has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the United States and India.

The US Food and Drug Administration (FDA) requested that Newron complete additional short-term explanatory studies in rats and humans to address concerns from a study of evenamide in rats, and CNS events observed following high-dose administration of evenamide in dogs.

The data from study 008 will be a key component in the package of information to be submitted to the FDA to support the approval of the initiation of Newron's planned phase III pivotal trial program for evenamide. Preclinical results confirming absence of toxicity have already been submitted to the FDA to support this package.

The proposed phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. Clozapine is the only antipsychotic approved worldwide for treatment-resistant schizophrenia.