Clinical results and new findings of
mechanism of action indicate evenamide would be uniquely effective
in patients with treatment resistant schizophrenia
Leading schizophrenia experts predict
earlier use of evenamide would benefit patients with inadequate
response
Evenamide’s unique mechanism of action
targets the core abnormalities in patients with schizophrenia and
reduces hippocampal dopaminergic activity, improving symptoms of
psychosis, social interactions and cognition
Long-term benefits of evenamide as an add-on
therapy were presented: 25% of treated patients met the criteria
for remission suggesting evenamide may positively affect the
long-term course of schizophrenia in TRS patients
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), welcomed investors, analysts and
media today to its well-attended investor day in New York City. The
event focused on the Company’s clinical, scientific and commercial
plans for evenamide, its investigational drug candidate in Phase
III clinical development for the potential treatment of patients
with chronic and TRS.
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Newron Pharmaceuticals 2024 Investor
Day
The event featured three leading schizophrenia experts who
presented on the unmet medical needs in schizophrenia, as well as
new concepts and recent neurobiological findings for treating poor
responders and patients with TRS. An outline of Newron’s Phase III
clinical development plan in TRS was also presented.
Breakthrough pre-clinical data supporting evenamide in the
treatment of TRS
Anthony Grace, Ph.D., Editor-in-Chief, International Journal of
Neuropsychopharmacology, Distinguished Professor of Neuroscience,
and Professor of Psychiatry and Psychology at the University of
Pittsburgh, stated, “The hippocampal hyper dopaminergic activity in
patients with schizophrenia contributes to the development of
symptoms of psychosis, loss of functioning, decreased social
interactions and deterioration of cognition.”
Dr. Grace further stated, “Evenamide’s glutamate modulation has
produced dramatic effects in the MAM model of schizophrenia, which
closely mimics the changes observed in patients with schizophrenia.
In this model, evenamide reversed abnormal hippocampal neuronal
activity, normalized dopamine neuron population activity, improved
cognition and normalized social interactions. Its effects on
neuronal firing, which persisted well beyond its half-life,
indicated that it induces neuronal plasticity and may help with
neuronal repair. Furthermore, by acting at the site of pathology,
evenamide might also be effective for negative symptoms and
cognitive dysfunction.”
Data from first evenamide placebo-controlled randomized
study
John Kane, M.D., Co-Director and Professor, Institute of
Behavioural Science, Feinstein Institutes for Medical Research, and
Professor of Psychiatry, Donald and Barbara Zucker School of
Medicine at Hofstra/Northwell stated: “A substantial proportion of
patients with schizophrenia do not respond well to first-line
medications, and this is true even at the onset of illness. This
may be because there are biological changes in the brains of
patients that show reduced benefit and non-response to treatments,
compared with patients who respond adequately to treatment.”
“Patients who are poor responders are likely to relapse more
than patients who respond to medication,” stated Kane. “To date,
there are no studies which have demonstrated that the addition of
one antipsychotic to another, or switching antipsychotics, has
produced any benefit to inadequate responders and TRS
patients.”
Dr Kane continued, “The evenamide 008A study is unique in
demonstrating a significant benefit in patients who were moderately
to severely psychotic, while being compliant with their
antipsychotic medication. This therapeutic benefit may derive from
evenamide’s glutamate modulation activity. The drug was extremely
well tolerated, without any of the usual side effects of available
antipsychotics.”
Results from an open label, long-term study of evenamide as
add-on therapy in TRS
Stephen R. Marder, M.D., Distinguished Professor of Psychiatry,
Semel Institute of Neuroscience & Human Behavior, and Director,
Section on Psychosis, UCLA Neuropsychiatric Institute stated:
“One-third of patients with schizophrenia are treatment resistant
and the only drug available, clozapine, is used in less than 5% of
patients. The use of higher doses, the addition of another
antipsychotic, or switching to another drug is unsuccessful in
patients with TRS.”
Dr. Marder continued, “The one-year results from studies where
evenamide was added to antipsychotics are noteworthy, as the
sustained and continuous improvement across all efficacy measures
is virtually unknown in patients with TRS. Similarly, the
conversion of TRS patients to a non-resistant state, as well as the
finding that 25% of patients met criteria for remission, is
remarkable and unprecedented.”
A new placebo controlled, one-year trial in patients with TRS
who are receiving other antipsychotics is in planning with Dr.
Marder as the Principal Investigator.
An outline of the late-stage clinical development for
evenamide in TRS
Ravi Anand, MD, Newron’s Chief Medical Officer, provided an
update on evenamide’s clinical program, outlining that evenamide’s
promising results will be evaluated in a Phase III randomized,
double-blind, one-year trial. The trial will compare evenamide to
placebo as add-on treatments in at least 400 TRS patients. The
primary efficacy endpoint will be change from baseline in PANSS1
scores at 12 weeks. Following this initial period, subjects will
continue on their assigned treatment until week 26, for the second,
maintenance efficacy endpoint, and then on to 1 year for read-out
of the third (one-year, long term) efficacy endpoint. The long-term
extension will also serve to evaluate the long-term safety and
tolerability of evenamide.
Stefan Weber, Chief Executive Officer of Newron
Pharmaceuticals, commented: “As highlighted by the three
world-leading KOLs, evenamide has enormous potential, if approved,
in addressing the significant unmet medical needs of patients with
chronic and treatment-resistant schizophrenia. We continue to
explore all options, including partnering, that could enable us to
complete the Phase III clinical development of evenamide, which we
believe could have blockbuster potential.”
A replay of the event is available on the Company’s website for
one month after the date of the event:
https://www.newron.com/investors/reports-and-presentation/year/2024#reports,-presentations-&-webcasts
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,
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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
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marketing of products, including without limitation difficulties in
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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.
________________________________ 1 Positive and Negative
Syndrome Scale (PANSS) is widely used in clinical trials of
schizophrenia and is considered the “gold standard” for assessment
of antipsychotic treatment efficacy (Innvo Clin Neurosci, 2017:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5788255/)
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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