ZURICH, SWITZERLAND / ACCESSWIRE / September 19, 2022 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP), (Nasdaq: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, announces that it will host a Virtual Key Opinion Leader ("KOL") Event to review top-line results from its Phase 2a clinical trial evaluating Quilience® (Mazindol ER) in the treatment of excessive daytime sleepiness (EDS) and cataplexy, the two core symptoms of narcolepsy. The event will feature study investigators and an independent practitioner that will discuss the clinical results and offer perspectives on the potential for Quilience® to treat patients with both narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). A Question-and-Answer session will follow the presentation of the results and KOL discussion.
Details for NLS Pharmaceutics' Quilience® Phase 2a KOL Event:
Date/Time: September 30, 2022; 10:00am to 11:30am Eastern Time
Registration: Please use the following link to both register and access the event at the designated date and time: https://wsw.com/webcast/cc/nlsp/1390158
Moderator: George Apostol, M.D., Chief Medical Officer & Global Head of R&D, NLS Pharmaceutics
Bruce Corser, M.D., Medical Director, Sleep Management Institute, Cincinnati, OH: Pulmonary and Sleep Medicine Specialist
Anne Marie Morse, D.O., Geisinger Medical Center, Danville, PA: Specialties in Pediatric Neurology and Sleep Medicine
Thomas Stern, M.D., Novant Health, Huntsville, NC: Advanced Respiratory and Sleep Medicine Specialist
About the Phase 2a trial (NLS-1021)
NLS-1021 is a multi-center, randomized, prospective Phase 2a clinical trial evaluating Quilience® (mazindol extended release or "ER") as a once-daily monotherapy for the treatment of EDS and cataplexy, the primary symptoms of narcolepsy. The trial was designed to enroll 60 patients diagnosed with NT1 or NT2 to receive treatment with either Quilience® 3mg once daily for 28 days, or placebo. A total of 67 patients were enrolled and randomized 1:1 into each treatment arm. The primary endpoint of the trial is the change from baseline in EDS as measured by the Epworth Sleepiness Scale (ESS), and a key secondary endpoint is the change from baseline in mean weekly number of cataplexy attacks in the subset of patients with cataplexy. Patients completing the 4-week clinical study period were eligible to enroll in an open label extension study (NLS-1022), where each patient was given the option to receive Quilience® monotherapy for up to an additional 6 months.
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics Ltd. is a Swiss 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 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 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 2a multi-center U.S. clinical trial evaluating Quilience® in adult subjects suffering from narcolepsy has been completed, with top-line results expected to be reported in the third quarter of 2022. Previously, NLS successfully completed a Phase 2 study in the U.S. evaluating Nolazol®(Mazindol Controlled-Release) in adult subjects 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 expected timing of the top-line results of the Phase 2a clinical trial.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; 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.
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SOURCE: NLS Pharmaceutics AG
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