EQS-News

Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS)

EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results Data from Newron’s study 014/015 and an evenamide clinical development outlook presented at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) 08.04.2024 / 07:00 CET/CEST The issuer is solely responsible for the content of this announcement.  Data from Newron’s study 014/015 and an

evenamide clinical development outlook presented at

the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS)

Data from study 014/015, a phase II trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS) for up to one year

Presentation of study design for potentially pivotal phase III trial for TRS patients

Information on potentially pivotal study 008A in non-TRS patients presented, with results expected in late April 2024 

Milan, Italy, April 8, 2024 – 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 four posters and two oral presentations at the 2024 Annual Congress of the Schizophrenia International Research Society (SIRS) from 3-7 April in Florence, Italy. The data presented were detailing previously reported scientific results of study 014/015, the future clinical development outlook for evenamide and information on study 008A.

Study 014/015 was 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 adequately to their current antipsychotic medication.

As previously announced by Newron, the study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events. Treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment. Gradual and sustained improvement was demonstrated across all efficacy scales used. More than 70% of patients experienced clinically important reduction in disease severity at one-year. Review of the efficacy data indicated that treatment with evenamide resulted in approximately 50% of patients at one-year no longer meeting any of the protocol severity criteria used to diagnose treatment resistance. Importantly, 25% of all patients achieved “remission” (no/minimal symptoms for at least six months), not reported before in TRS patients. Moreover, in contrast to common clinical experience, no patient relapsed during the one-year treatment period.