Full Press Release Details
Pharmaceutics Highlights Innovative Preclinical Program for First-in-Class Non-Sulfonamide Dual Orexin Receptor Agonists (DOXA) in Narcolepsy
and Neurological Disorders
Switzerland, November 18, 2024 - NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) ("NLS" or the "Company"),
a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare
and complex central nervous system disorders, provided insights today into the preclinical program evaluating its dual orexin receptor
agonist (DOXA) platform. AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs, are designed to target both orexin-1 (OX1R) and
orexin-2 (OX2R) receptors while concurrently inhibiting cathepsins. This unique approach aims to address the unmet therapeutic needs
in narcolepsy and related neurological disorders.
ongoing studies are conducted at the Centre for Neuroscience Research of Lyon, a world-class institution specializing in
sleep and neurological research. The experimental framework is designed to explore the therapeutic potential of AEX compounds using an
international validated orexin knockout (ORX-KO) mouse model of narcolepsy.
elements of the study include:
Superiority Over Selective OX2R Agonists
existing selective OX2R agonists have demonstrated efficacy in managing narcolepsy symptoms, DOXA are expected to surpass these benchmarks.
By engaging both OX1R and OX2R receptors and addressing broader neurological pathways, AEX-41 and AEX-2 offer the potential for enhanced
therapeutic outcomes, including greater wakefulness stability and improved sleep quality under real-world conditions.
Konofal, MD, PhD, Chief Scientific Officer of NLS, stated, "Our preclinical program reflects our commitment to redefining the treatment
landscape for narcolepsy and related disorders. The advanced study design and methodology we've implemented aim to demonstrate
not only the efficacy of our compounds but their potential superiority in addressing both symptoms and underlying disease mechanisms."
remains committed to advancing its pipeline and anticipates providing further updates as the preclinical program progresses. First results
from the ongoing study are expected to be shared in early December 2024. The Company's broader development plans include exploring
the application of its DOXA platform also in other neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis (ALS).
NLS Pharmaceutics Ltd.:
Pharmaceutics is a global biopharmaceutical company dedicated to developing innovative therapies for rare and complex central nervous
system disorders. With a robust pipeline addressing significant unmet medical needs, NLS is poised to redefine the treatment landscape
for sleep and neurological health. NLS has recently entered into a merger agreement with a clinical phase company.
more information, visit www.nlspharma.com.
press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is
using forward-looking statements when it discusses the DOXA platform, the potential safety and efficacy of AEX-41 and AEX-2, plans to
expand its research and timing thereof, and NLS' pipeline. 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 products may not be approved
by regulatory agencies, NLS 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' process; NLS' 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 patents may not be sufficient; NLS products may harm recipients; changes in
legislation may adversely impact NLS; inability to timely develop and introduce new technologies, products and applications; and 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 annual report on Form 20-F for the year ended December 31, 2023 filed with the Securities
and Exchange Commission (SEC), which is available on the SEC's website, www.sec.gov, and in subsequent filings made by NLS with