Ad hoc announcement pursuant to Art. 53
LR
Further study analysis reveals significant
multi-domain benefits in PANSS and Clinical Global Impression of
Change (CGI-C) ratings
Benefit on efficacy measures increased over
time, suggesting larger and enduring patient effects to be expected
during long-term treatment
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), presents additional results from
the international, randomized, double-blind, placebo-controlled
study 008A that evaluated the efficacy and safety of evenamide (30
mg bid) as add-on treatment in 291 patients not benefitting from
their second-generation antipsychotic medication, including
clozapine. Initial top line data announced on 30th April 2024
demonstrated that the study met its primary endpoint, an
improvement of the Positive and Negative Syndrome Scale (PANSS)
Total Score as well as the key secondary endpoint, an improvement
of the Clinical Global Impression of Severity (CGI-S), in the
a-priori defined regulatory analysis.
Additional analyses for the secondary endpoints indicate
significant effects achieved at the endpoint (Day 29), on all the
following measures:
- PANSS total: Proportion of patients with a clinically relevant
improvement (more than 20% improvement from baseline); p-value <
0.05; - Clinical Global Impression of Change (CGI-C): Mean rating
at endpoint; evenamide 3.3 versus placebo 3.5; p-value < 0.001;
- Clinical Global Impression of Change (CGI-C): Proportion of
patients rated as showing any improvement; p-value < 0.05; -
Clinical Global Impression of Change (CGI-C): Proportion of
patients rated as at least “much improved”; evenamide: 31.3% versus
placebo: 17.3%; p-value = 0.006; - PANSS Positive subscale: Mean
change from baseline; p-value < 0.05; - PANSS Negative subscale:
Mean change from baseline; p-value < 0.05.
The sensitivity analyses for the PANSS total (primary endpoint)
and CGI-S (secondary endpoint) confirmed a statistically
significant improvement for evenamide irrespective of the
population analyzed and the statistical methods used; some examples
are provided below:
- PANSS total worst observation carried forward (WOCF) ANCOVA
p-value = 0.008; - PANSS total Multiple Imputation (MI) ANCOVA:
p-value = 0.006; - CGI-S Multiple Imputation (MI) ANCOVA: p-value =
0.014.
In the study, the addition of 30 mg (bid) of evenamide to the
patients’ current antipsychotic medication was very well tolerated,
with a similar profile to placebo with no increases in EPS, weight
gain, blood glucose, metabolic syndrome, sexual dysfunction, CNS or
cardiac effects, or laboratory abnormalities.
Study 008A is the first well-designed study demonstrating
efficacy of an adjunctive treatment in benefiting patients who do
not respond to their current antipsychotic. Evenamide also is the
first glutamate modulator to demonstrate efficacy in inadequately
responding patients with schizophrenia in a placebo-controlled
study.
Ravi Anand, MD, Chief Medical Officer of Newron, stated:
“These new efficacy results from study 008A attest to the clinical
relevance of the benefits for patients, based on the primary and
key secondary endpoints. The results for the CGI-C rated by an
experienced psychiatrist who assesses not only the symptoms of
psychosis, but also the impact of treatment on social interactions,
insight, and functioning, indicated a significant proportion of
evenamide patients were considered as at least ‘much improved’.
Significant improvement was also noted on both positive and
negative symptoms of schizophrenia. Most importantly, the
benefits noted on the efficacy measures increased up to Day 29,
thus suggesting larger and enduring effects during longer term
treatment. These findings, along with those noted in study
014/015, where patients with treatment resistant schizophrenia
treated with evenamide for 1-year experienced progressive,
sustained and long-lasting clinically significant important
benefits, further highlight the growing importance of glutamate
modulation for the development of novel treatments for patients
with schizophrenia.”
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 Newron Pharmaceuticals
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 Milan, Italy. Xadago®/safinamide
has received marketing authorization for the treatment of
Parkinson’s disease in the European Union, Switzerland, the UK, the
USA, Australia, Canada, Latin America, Israel, the United Arab
Emirates, Japan and South Korea, and is commercialized by Newron’s
Partner Zambon.
Supernus Pharmaceuticals holds the commercialization rights in
the USA. Meiji Seika has the rights to develop and commercialize
the compound in Japan and other key Asian territories. Newron is
also developing evenamide as the potential first add-on therapy for
the treatment of patients with symptoms of schizophrenia. For more
information, please visit: www.newron.com
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 SIX Swiss Exchange or the Dusseldorf Stock
Exchange where the shares of Newron are listed. This document does
not contain or constitute an offer or invitation to purchase or
subscribe for any securities of Newron and no part of it shall form
the basis of or be relied upon in connection with any contract or
commitment whatsoever.
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version on businesswire.com: https://www.businesswire.com/news/home/20240513804374/en/
For more information: Newron Stefan Weber – CEO +39 02
6103 46 26 pr@newron.com
UK/Europe Simon Conway / Ciara Martin / Natalie
Garland-Collins, FTI Consulting +44 20 3727 1000
SCnewron@fticonsulting.com
Switzerland Valentin Handschin, IRF +41 43 244 81 54
handschin@irf-reputation.ch
Germany/Europe Anne Hennecke / Caroline Bergmann, MC
Services +49 211 52925222 newron@mc-services.eu
USA Paul Sagan, LaVoieHealthScience +1 617 374 8800, Ext.
112 psagan@lavoiehealthscience.com