Full Press Release Details
NLS Pharmaceutics Receives Green Light from
the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience (Mazindol ER) for the treatment of Narcolepsy
Z rich, Switzerland,
May 2, 2023 - 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, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the
Phase 3 program for Quilience (Mazindol ER). The AMAZE Program will encompass two double-blind Phase 3 trials (N=50 each) investigating
Mazindol ER versus placebo in adult patients with narcolepsy, commencing this summer at multiple sites in the U.S.
Both phase 3 trials,
NLS-1031 and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment. Patients who complete
these studies will be offered participation in a 12-month open-label extension (OLE) study (Study NLS-1033). To be eligible for enrollment
into the program, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.
Alex Zwyer, Chief Executive
Officer of NLS, said, "We thank the FDA for the approval of this clinical program to evaluate Quilience in chronically
ill patients suffering from narcolepsy and we are thrilled to start recruiting for the U.S. clinical trial this summer. Today's
announcement builds on our commitment and focus to awaken a brighter future for patients with rare and complex central nervous system
NLS previously reported
on the Phase 2 study results in narcolepsy in which Quilience (Mazindol ER) met all primary and secondary endpoints. Patients treated
with Mazindol ER in the randomized Phase 2 trial showed continued improvement after rolling over into the OLE study and patients treated
with placebo in the randomized Phase 2 trial and who subsequently received Mazindol ER in the OLE study achieved comparable results to
the Mazindol ER-treated patients in the Phase 2 trial. Data from the Phase 2 studies will be presented at SLEEP 2023, the annual meeting
of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), which is being held from June 3 - 7, 2023, in Indianapolis.
that the FDA has approved our clinical development plan in narcolepsy patients. We believe that the FDA's approval affirms the Company's
path to securing approval for Mazindol ER in order to treat a life-long chronic disorder with high unmet medical needs," says George
Apostol, Chief Medical Officer.
About NLS Pharmaceutics
NLS Pharmaceutics Ltd.
(Nasdaq: NLSP) is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally
recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous
system, or CNS, disorders, who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced
management team with a track record of developing and commercializing product candidates. For more information, please visit www.nlspharma.com.
The Company's lead product
candidate, Quilience , is a proprietary extended-release formulation of mazindol (mazindol ER) and is being developed for
the treatment of narcolepsy, and potentially other sleep-wake disorders such as Idiopathic Hypersomnia (IH), for which NLS recently obtained
Orphan Disease Designation (ODD) from the FDA and the European Medicines Agency (EMA). 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. A Phase 2 multi-center U.S. clinical study evaluating Quilience
in adult patients suffering from narcolepsy met its primary endpoint with high statistical significance and demonstrated a favorable safety
and tolerability profile. NLS also successfully completed a Phase 2 study in the U.S. evaluating Nolazol
(Mazindol Controlled-Release) in adult patients suffering from ADHD. The study met all primary and secondary endpoints and Nolazol
was well-tolerated. Quilience has received Orphan Drug Designations both in
the U.S. and in Europe for the treatment of narcolepsy. Up to 1/3 of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This 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 potential benefits of mazindol ER, the timing and the expected format of the AMAZE Phase 3 clinical program and the belief that the
FDA's approval affirms NLS' path to securing approval for Mazindol ER in order to treat a life-long chronic disorder with
high unmet medical need. 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, 2021 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 the SEC.
For additional information:
Marianne Lambertson (investors & media)
NLS Pharmaceutics Ltd.