DJ EQS-News: Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly responding schizophrenia patients

===
EQS-News: Newron Pharmaceuticals S.p.A. / Key word(s): Study results
Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly
responding schizophrenia patients
2024-05-13 / 07:00 CET/CEST
The issuer is solely responsible for the content of this announcement.
Newron reports compelling additional data documenting the efficacy of evenamide in pivotal study 008A in poorly
responding schizophrenia patients
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
Milan, Italy, May 13, 2024, 07:00 am CEST - 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 30^th 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.
For more information, please contact: 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
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
===
(MORE TO FOLLOW) Dow Jones Newswires

May 13, 2024 01:00 ET (05:00 GMT)

===
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.
2024-05-13 CET/CEST Dissemination of a Corporate News, transmitted by EQS News - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
The EQS Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.

Archive at www.eqs-news.com  
Language:     English 
Company:      Newron Pharmaceuticals S.p.A. 

via Ludovico Ariosto 21
20091 Bresso
Italy

Phone:        +39 02 610 3461 
Fax:          +39 02 610 34654 
E-mail:       pr@newron.com 
Internet:     www.newron.com 
ISIN:         IT0004147952 
WKN:          A0LF18 
Listed:       Regulated Unofficial Market in Dusseldorf (Primärmarkt); London, SIX 
EQS News ID:  1900835 

End of News EQS News Service
===
1900835 2024-05-13 CET/CEST

Image link: https://eqs-cockpit.com/cgi-bin/fncls.ssp?fn=show_t_gif&application_id=1900835&application_name=news

END) Dow Jones Newswires

May 13, 2024 01:00 ET (05:00 GMT)