EQS-News

Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients

EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients 30.04.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement.  Newron announces positive top-line results from potentially pivotal Phase II/III study 008A with evenamide in schizophrenia patients

Primary endpoint and key secondary endpoint of study met; drug was well tolerated, with no safety concerns identified

Glutamatergic inhibition mechanism of action offers an innovative therapeutic option to schizophrenia patients not benefitting from current antipsychotic treatments

Next step: Potentially pivotal, Phase III, one-year, randomized, double-blind, placebo-controlled trial in treatment resistant schizophrenia (TRS)

International conference call today at 3:00 PM CET/9:00 AM ET

Milan, Italy, April 30, 2024, 07:00 am CEST – 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 (CNS), today announced positive top-line results from its potentially pivotal study 008A, evaluating the safety, tolerability and efficacy of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic including clozapine, but demonstrating an inadequate response to that treatment. The study met its primary endpoint of improvement on the Positive and Negative Syndrome Scale (PANSS) Total Score as well as the key secondary endpoint of improvement of the Clinical Global Impression of Severity (CGI-S).

Study 008A was a four-week, international, randomized, double-blind and placebo-controlled add-on Phase II/III study performed in 45 centers in 11 countries in Europe, Asia and Latin America. 291 patients were randomized to treatment either with evenamide or placebo as add-on to their current antipsychotic therapy.

Evenamide confirmed its favourable safety and tolerability profile, with a high rate of completion. Two hundred and eighty of the 291 patients completed the study with only three patients discontinuing the study due to adverse events, two of them on evenamide and one patient on placebo who died during the study.  No new or specific concerns were raised in the study; only 25% of the patients in the study experienced at least one adverse event (evenamide 25% versus placebo 25.8%). There was no difference in the incidence of CNS, psychiatric, gastrointestinal or other adverse events between evenamide and placebo. The most common adverse events reported in patients treated with evenamide were headache, vomiting and nasopharyngitis (three patients, each); similar numbers of patients on placebo experienced these adverse events.