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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

13.05.2024 / 07:00 CET/CEST
The issuer is solely responsible for the content of this announcement.

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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 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.

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 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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13.05.2024 CET/CEST Dissemination of a Corporate News, transmitted by EQS
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   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
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1900835 13.05.2024 CET/CEST