Newron presents encouraging interim results for evenamide in patients with Treatment-Resistant Schizophrenia (TRS) at the 33rd CINP Hybrid World Congress of Neuropsychopharmacology
Interim results show improved symptoms of psychosis in patients with chronic TRS
Study 014 represents first international trial of a New Chemical Entity (NCE) antipsychotic as an add-on in TRS, with treatment implications for TRS patients
Newron to host an investor, analyst and media conference call today at
Ad hoc announcement pursuant to Art. 53 LR
The results presented at the 33rd
Newron expects to initiate a potentially pivotal, multinational, randomized, placebo-controlled study in patients with treatment resistant schizophrenia in the first quarter of 2023, as part of its ongoing Phase II/III development plan for evenamide.
Study 014 design
This six-week, randomized, rater-blinded study is being conducted at multiple sites in three countries. The study will include approximately 180 patients with TRS on a stable, therapeutic dose of a single antipsychotic other than clozapine. The primary objective of the study is to evaluate the safety and tolerability of evenamide given orally at three fixed doses (7.5, 15 and 30 mg bid). The assessment of preliminary efficacy, based on changes from baseline in the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Change from baseline (CGI-C), Severity of illness (CGI-S), and
Patients were moderately to severely ill (CGI-S of 4 to 6), with a baseline PANSS total score ≥70 and <90 and predominant positive symptoms (score of 4 or more on at least 2 core symptoms, along with a total score of at least 20 on these 4 core items plus 3 other positive symptoms), along with functional deficits (GAF ≤50). Efficacy and safety assessments were conducted at one to two-week intervals. Patients participating in the study are continuing to receive treatment with evenamide in long-term extension study 015 to determine the long-term benefits of glutamate release inhibition.
The call can be accessed via the following dial-in numbers:
The presentation for this conference call as well as the abstracts/videos presented at the 33rd
About treatment-resistant schizophrenia
About one third of patients with schizophrenia, of which about 15% from illness onset, show virtually no beneficial response to antipsychotics (APs), despite adequate treatment. They are diagnosed as having treatment-resistant schizophrenia (TRS), operationally defined as no, or inadequate, symptomatic reliefdespite treatment with therapeutic doses of two antipsychotics from two different chemical classes for an adequate period. Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, to explain the lack of benefit of most typical and atypical antipsychotics.
Evenamide has the potential to be the first add-on therapy for the treatment of patients with schizophrenia. The compound is an orally available New Chemical Entity that specifically targets voltage-gated sodium channels. Evenamide originates from Newron’s ion channel program and has a unique mechanism of action: glutamate modulation and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing without inducing impairment of normal neuronal excitability. It normalizes glutamate release induced by aberrant sodium channel activity. In a Phase IIa clinical study, Newron demonstrated evenamide’s evidence of efficacy in significantly improving symptoms of psychosis compared with placebo when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia. The study also indicated that evenamide is devoid of an effect on any of the over 130 neurotransmitters, enzymes, or transporters targeted by most antipsychotics. Studies in more than 400 healthy volunteers and patients with schizophrenia have met the objective of safety on all variables.
Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near
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