EQS-News: Newron Pharmaceuticals S.p.A.
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Newron presents six-month interim data from the first 100 patients randomized in study 014/015 at the 31st European Congress of Psychiatry Study 014/015 is a Phase II trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS) Full data suggest a new strategy for the management of TRS patients in the future A new definition of TRS patient responders indicated, which integrates three widely accepted scales Milan, Italy, March 28, 2023, 12:30 pm CET – 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), presented two e-posters at today’s “Schizophrenia and other psychotic disorders” session at the 31st European Congress of Psychiatry, taking place at the Palais des Congrès in Paris, France. New data suggestive of clinically important response in TRS patients The first poster presented full results from the cohort of the first 100 patients completing six months/endpoint of treatment with evenamide in study 014/015. Study 014/015 is an international, randomized, open label, rater-blinded study of evenamide as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe treatment-resistant schizophrenia (TRS) not responding to their current antipsychotic medication. Top-line six-month results from this cohort of patients were announced in January 2023, and top-line one-year results were announced in February 2023. Key findings and conclusions at six months:
This was the first international trial of an antipsychotic new chemical entity (NCE) as an add-on to a single antipsychotic in patients with TRS who were not responding to their current medication. These results suggest a new strategy for the management of TRS patients in the future. The poster is available at Newron’s website. New responder definition indicated for TRS The second poster detailed the characterization of “Responder” in TRS patients based on data from this study. Key findings and conclusions: A widely accepted definition of response in patients with TRS treated with a putative antipsychotic added to their background antipsychotic monotherapy is currently not available. Following a thorough analysis of the results from this first study evaluating the add-on therapy with evenamide in TRS, the aim was to determine a definition of responder that integrated three of the most accepted scales to evaluate patients with schizophrenia worldwide, the PANSS, the CGI-S and the CGI-C. The following two definitions resulted from that analysis:
The poster is available at Newron’s website. About treatment-resistant schizophrenia (TRS) About study 014/015 About evenamide About Newron Pharmaceuticals For more information, please contact: Newron UK/Europe Switzerland Germany/Europe USA
28.03.2023 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG. |
1594303 28.03.2023 CET/CEST
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