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) 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. Also previously announced, in their totality, the results from study 014/015 support the initiation of a potentially pivotal phase III, randomized, double-blind, placebo-controlled study of evenamide as an add-on treatment in patients with TRS, which will hopefully confirm the benefit of evenamide observed so far. If approved, the compound would be the first add-on drug that improves the symptoms of TRS, offering a much-needed new therapeutic option for those who are not responding to existing antipsychotics. A poster outlining the design of this potentially pivotal study was presented at SIRS. Newron is also investigating evenamide in a potentially pivotal study (study 008A) in a separate indication: in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid). Patient enrollment has completed and results from this study are expected in late April 2024. Additional information on this study was outlined in an oral presentation at SIRS. The posters presented at the SIRS conference were titled:
The presentations made at SIRS were titled:
All posters and presentations presented are available at Newron’s website.
About treatment-resistant schizophrenia (TRS) About Study 014/015 About evenamide About Newron Pharmaceuticals
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