STANS, Switzerland,
May 18, 2021 /PRNewswire/ -- NLS
Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"),
a Swiss clinical-stage pharmaceutical company focused on the
discovery and development of innovative therapies for patients with
rare and complex central nervous system disorders, announces new
study data which support the mechanism of action for mazindol, the
active compound in the Company's lead product candidate to treat
narcolepsy, Quilience®. Narcolepsy is caused by a deficiency in
orexin, a neuropeptide that regulates the sleep-wake cycle. The new
data confirm mazindol's Orexin-2 receptor (OX2R) agonist
activity.
In the pre-clinical study conducted by the Department of
Biomedical Sciences at the University of Lausanne and sponsored by
NLS, mice that were genetically modified not to express
OX2R (Knock-Out mice) and Wild-Type mice (normal mice) were
investigated for psychostimulant effects when mazindol was
administered. The study demonstrated that Knock Out mice were 70%
less sensitive to mazindol compared to normal mice, confirming
mazindol's potent activity as an OX2R agonist.
Ongoing studies sponsored by the Company are intended to further
confirm and extend this finding to the wake-promoting and
anti-cataplexy effects of mazindol, which have been observed in
human studies and in clinical practice when the drug was prescribed
to treat narcolepsy in compassionate use programs. NLS believes
that the new data also support prior in-vitro data from
studies conducted by the Company demonstrating the partial binding
affinity of mazindol to OX2R, which NLS believes is a key pathway
that mediates mazindol's stimulant-like effects. Mazindol is a
scheduled IV controlled substance unrelated to amphetamine salts,
which are highly regulated and have restricted use.
"We believe these study results confirm that mazindol has a
surprisingly unique mode of action, not only as a reuptake blocker
of monoamines in the central nervous system like other stimulants,
but also having psychostimulant effects through the activation of
OX2R," said Mehdi Tafti, Ph.D.,
Professor at the University of Lausanne, Department of Biomedical
Sciences. "Given that narcolepsy is caused by orexin deficiency,
this finding is important as mazindol has the potential to become
the first-available treatment targeting Orexin-2 receptors, and the
first evidence-based medicine to address this chronic sleep
disorder."
"The results of this Knock Out mouse study demonstrate
mazindol's potent binding activity to OX2R, which we believe will
translate into clinically meaningful results in humans suffering
from the core symptoms of narcolepsy – excessive daytime sleepiness
and cataplexy attacks," said Eric Konofal, M.D., Ph.D., Co-founder
and interim Chief Scientific Officer of NLS. "Clinical data from
real-world mazindol use, as well as trial results from other
orexin-activating compounds validate the utility of orexin receptor
stimulation and the potential benefits to both narcolepsy Type 1
and narcolepsy Type 2 patients. We believe that
Quilience® will provide a differentiated solution in this
treatment category given mazindol's dual mechanism of action,
namely orexin pathway activation and pan-monoaminergic reuptake
inhibition in the brain. Overall, we believe that the unique
pharmacological profile of mazindol will offer synergies that could
translate into improved efficacy compared to current treatments, as
well as those in development that purely target OX2R.
"We are dedicated to the development of Quilience®, our
proprietary controlled-release formulation of mazindol, which we
believe has the potential to provide a superior solution in the
treatment of narcolepsy by addressing the disorder at its root
cause," said Alexander Zwyer, Chief
Executive Officer of NLS. "Mazindol has been used over many years
to treat refractory narcoleptic patients off-label, with evidence
of favorable efficacy and safety. We believe that these new
preclinical results further support the rationale for our clinical
program intended to bring mazindol back to the market in an
optimized formulation that can benefit patients diagnosed with
narcolepsy and potentially other sleep-wake disorders."
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a Swiss-based clinical-stage
biopharmaceutical company led by an experienced management team
with a track record of developing and repurposing product
candidates to treat rare and complex central nervous system
disorders. The Company's lead product candidate, Quilience® is a
proprietary controlled release formulation of mazindol (mazindol
CR), and is being developed for the treatment of narcolepsy.
Mazindol is a triple monoamine reuptake inhibitor and partial
Orexin-2 receptor agonist, which was used for many years to treat
patients diagnosed with narcolepsy in compassionate use programs.
NLS completed a Phase 2 study in the U.S. evaluating mazindol CR in
adult subjects with ADHD. The study met all primary and secondary
endpoints and was well-tolerated. Quilience® has received Orphan
Drug Designations both in the U.S. and in Europe for the
treatment of narcolepsy.
Safe Harbor Statement
This press release contains express or implied forward-looking
statements pursuant to U.S. Federal securities laws. For example,
NLS is using forward-looking statements when it discusses the
intent of ongoing and future studies, its belief that
the partial binding affinity of mazindol to OX2R is a key
pathway that mediates mazindol's psychostimulant effects, the
belief that mazindol has a unique mode of action and that mazindol
has the potential to become the first-available treatment targeting
Orexin-2 receptors and the first evidence-based medicine to address
this chronic sleep disorder, that Quilience® may potentially
provide a superior solution in the treatment of narcolepsy by
addressing its root cause, that the results from the announced
preclinical study support results of prior NLS studies, and that
the results from the announced preclinical study support the
rationale for bringing mazindol back to the market. These
forward-looking statements and their implications are based on the
current expectations of the management of NLS only, and are subject
to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the
forward-looking statements. The following factors, among others,
could cause actual results to differ materially from those
described in the forward-looking statements: changes in technology
and market requirements; NLS may encounter delays or obstacles in
launching and/or successfully completing its clinical trials; NLS's
products may not be approved by regulatory agencies, NLS's
technology may not be validated as it progresses further and its
methods may not be accepted by the scientific community; NLS may be
unable to retain or attract key employees whose knowledge is
essential to the development of its products; unforeseen scientific
difficulties may develop with NLS's process; NLS's products may
wind up being more expensive than it anticipates; results in the
laboratory may not translate to equally good results in real
clinical settings; results of preclinical studies may not correlate
with the results of human clinical trials; NLS's patents may not be
sufficient; NLS's products may harm recipients; changes in
legislation may adversely impact NLS; inability to timely develop
and introduce new technologies, products and applications; loss of
market share and pressure on pricing resulting from competition,
which could cause the actual results or performance of NLS to
differ materially from those contemplated in such forward-looking
statements. Except as otherwise required by law, NLS undertakes no
obligation to publicly release any revisions to these
forward-looking statements to reflect events or circumstances after
the date hereof or to reflect the occurrence of unanticipated
events. More detailed information about the risks and uncertainties
affecting NLS is contained under the heading "Risk Factors" in
NLS's prospectus dated January 28,
2021 filed with the SEC, which is available on the SEC's
website, www.sec.gov.
Corporate Contact:
Alex
Zwyer, CEO: +41 41 618 80 00
Investor Relations Contact
David Moskowitz: +1 202-280-0888
www.nlspharma.com
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SOURCE NLS Pharmaceutics Ltd.