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Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

DGAP-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia 06.09.2021 / 07:00 The issuer is solely responsible for the content of this announcement. Newron Initiates First Potentially Pivotal Study with Evenamide in Patients with Schizophrenia

• Evenamide has the potential to be the first add-on therapy for patients with positive symptoms of schizophrenia
• Four-week, double-blind, placebo-controlled study to evaluate safety and efficacy of therapeutic dose (30mg BID)
• Minimum of 200 patients to be enrolled at study centers in Europe, Asia and Latin America
• Evenamide's glutamatergic inhibition mechanism of action offers an innovative therapeutic option to patients not benefitting from current antipsychotic treatments

Milan, Italy and Morristown, NJ, USA, September 6, 2021, 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, today announced the initiation of Study 008A, the first potentially pivotal study with evenamide in patients with schizophrenia.

Study 008A, a four-week, randomized, double-blind placebo-controlled international study, is designed to evaluate the efficacy, tolerability, and safety (including effects on the electroencephalogram (EEG)) of the 30mg BID therapeutic dose of evenamide in patients with chronic schizophrenia, currently being treated with a second-generation antipsychotic. Newron plans to randomize at least 200 patients in study centers in Europe, Asia and Latin America. Results from the study are expected by Q4 2022.

This study is part of Newron's Phase III evenamide clinical trial program that targets patients with schizophrenia experiencing worsening of psychosis on therapeutic doses of atypical antipsychotics, as well as treatment-resistant patients.

Ravi Anand, MD, Newron's CMO, commented: "Evenamide has been shown to be safe in studies treating more than 300 healthy volunteers and patients at doses of up to 60mg. Study 008A will now evaluate the efficacy, tolerability and safety of the therapeutic dose of 30mg BID. 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."