Newron announces striking six-month interim results from its exploratory clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia
Statistically significant, clinically meaningful improvements over baseline were seen across efficacy endpoints after six months; continued improvement was seen when compared with results after six weeks
Newron plans to commence a pivotal study in treatment-resistant schizophrenia in 2023
Investor and analyst conference call today at
Ad hoc announcement pursuant to Art. 53 LR
These new results demonstrated a continued improvement in TRS symptoms after six months of treatment with evenamide, as well as a substantially greater proportion of patients experiencing a meaningful improvement when compared to six weeks of treatment.
The efficacy results based on changes over baseline in the Positive and Negative Syndrome Scale (PANSS) showed a statistically significant improvement at week 30 (p-value < 0.001: paired t-test); continued improvement was seen when compared to the improvement seen at week six. The proportion of patients demonstrating a clinically meaningful PANSS improvement (“responders”) at week 30 more than doubled from 16.5% at week six. In addition, the mean change for the severity of illness (as measured by Clinical Global Impression of Severity (CGI-S)) showed a statistically significant improvement at week 30 compared to baseline (statistically significant, p-value < 0.001: paired t-test), as well as continued improvement when compared to week six, and the proportion of patients whose illness improved by at least one level of severity increased from 60% at week six by an additional approximately 20% at week 30. Furthermore, the proportion of patients judged to have clinically meaningfully improved (i.e. patients rated at least “much improved”) on the Clinical Global Impression of Change (CGI-C) increased by another 10% from the proportion at week six (27%). The addition of evenamide to the current antipsychotic medication of the patients continued to be well tolerated after six months of treatment.
The top-line results are based on the first 100 enrolled patients, randomized to receive evenamide (7.5 15 and 30 mg bid) in study 014 and the extension arm of the study, 015, to have reached the six-month timepoint. The majority of the first 100 patients were randomized to receive either the 7.5 and 15 mg bid doses, as patients were initially randomized to treatment with these doses before an Independent Safety Monitoring Board reviewed the safety data from the first 50 patients completing the trial and agreed with the randomization to the 30 mg bid dose.
Newron has submitted an abstract for the presentation of these latest results at the 31st
The enrollment of study 014 has been completed with 161 subjects. Newron expects to announce the full results from the study in
Newron expects to initiate a potentially pivotal, multinational, randomized, ten-week, placebo-controlled study (003) in TRS patients in 2023, as part of its ongoing Phase II/III development plan for evenamide. The first potentially pivotal study of this development program, study 008A with evenamide as add-on therapy in patients with chronic schizophrenia experiencing inadequate response to their current antipsychotics (but not classed as having TRS), is continuing to enroll patients, and results are expected in 2023.
Conference call
Newron’s CEO
The call can be accessed via the following dial-in numbers:
The presentation for this conference call can be downloaded as of today,
About treatment-resistant schizophrenia (TRS)
A significant proportion of patients with schizophrenia show virtually no beneficial response to antipsychotics (APs) despite adequate treatment, leading to a diagnosis of treatment-resistant schizophrenia (TRS). TRS is defined as no, or inadequate, symptomatic reliefdespite treatment with therapeutic doses of two APs from two different chemical classes for an adequate period. About 15% of patients develop TRS from illness onset, and about one-third of patients overall.
Increasing evidence supports abnormalities in glutamate neurotransmission in TRS, not targeted by current APs, along with normal dopaminergic synthesis, explaining the lack of benefit of most typical and atypical APs.
About evenamide
Evenamide, an orally available new chemical entity, specifically blocks voltage-gated sodium channels (VGSCs) and is devoid of biological activity at >130 other CNS targets. It normalizes glutamate release induced by aberrant sodium channel activity (veratridine-stimulated), without affecting basal glutamate levels, due to inhibition of VGSCs. Combinations of ineffective doses of evenamide and other APs, including clozapine, were associated with benefit in animal models of psychosis, suggesting synergies in mechanisms that may provide benefit in patients who are poor responders to current APs, including clozapine.
About study 014/015
Study 014 is a six-week, randomized, rater-blinded study being conducted at multiple sites in three countries (
About
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
Important Notices
This document contains forward-looking statements, including (without limitation) about (1) Newron’ s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the
View source version on businesswire.com: https://www.businesswire.com/news/home/20230103005219/en/
Newron
+39 02 6103 46 26
pr@newron.com
+44 20 3727 1000
SCnewron@fticonsulting.com
+41 43 244 81 54
handschin@irf-reputation.ch
+49 211 52925222
anne.hennecke@mc-services.eu
+1 617 374 8800, Ext. 112
psagan@lavoiehealthscience.com
Source: