MILAN, August 04, 2023–(BUSINESS WIRE)–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 its financial results and operational highlights for the half year ended June 30, 2023, and provided an update on its R&D and business activities.
Highlights H1 2023:
Evenamide
- Results from study 014/015, the first international trial of an antipsychotic new chemical entity (NCE) as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS)
- demonstrated evenamide’s efficacy on multiple measures of psychopathology
- support movement to potentially pivotal, multinational, randomized, placebo-controlled trial
- suggest a potential new strategy for the management of TRS patients
- Presentation of data to the medical community at several international psychiatry conferences, highlighting the multi-modal, clinically important response to evenamide in TRS patients, across various domains and multiple timepoints
- Publication of data from study 014/015 in the peer-reviewed International Journal of Neuropsychopharmacology, outlining the continued improvement in symptoms of psychosis in TRS patients receiving evenamide
- Following the publication of this encouraging data, the Company is working towards initiation of study 003, a potentially pivotal, multinational, randomized, double-blind, twelve-week, placebo-controlled study assessing the efficacy, safety and tolerability of evenamide (15/30 mg bid) as an add-on treatment in patients with TRS
- Evenamide (30 mg bid) is also being evaluated as a treatment in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic, in study 008A, a potentially pivotal four-week, randomized, double-blind and placebo-controlled study; patient recruitment is ongoing and on track to report full results by end of 2023/early 2024
