- 60-patient enrollment target met plus 12% over-enrollment; top-line Phase 2a results expected to be presented during the European Sleep Research Society Congress in September 2022
- Nearly 90% of patients completing the Phase 2a trial to date have rolled over into the open label extension (OLE) study
- Patients in the OLE study (both NT1 and NT2) remain on Quilience monotherapy, without any additional background stimulant, wake promoting or anti-cataplectic treatment; several patients on Quilience treatment for up to 6 months
ZURICH, SWITZERLAND / ACCESSWIRE / June 2, 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 its Phase 2a clinical trial for Quilience in the treatment of narcolepsy is now fully enrolled, with top-line results anticipated to be presented at a symposium during the European Sleep Research Society Congress (ESRS), being held September 27-30, 2022 in Athens, Greece. Additionally, the Company reports that enrollment and ongoing patient dosing in its OLE study for Quilience monotherapy continue to exhibit favorable trends.
"With patient enrollment now complete, we remain on track to report top-line efficacy and safety results from our Phase 2a narcolepsy trial for Quilience during the ESRS conference in late September," said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. "I believe that the over-enrollment of the trial demonstrates the high interest in our novel Mazindol ER formulation, as enrollment has significantly accelerated since we reported our positive interim results at the World Sleep Congress in March 2022. As we continue to execute on completing this trial, we are also continuing to work with our financial advisor to evaluate potential strategic partnerships and opportunities to bring Quilience to patients as quickly as possible."
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. 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 clinical trial evaluating Quilience® in adult subjects suffering from narcolepsy is currently ongoing in the United States. 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. EAPs have great potential to benefit all stakeholders involved, from the patient who receives the medicine early, to the pharmaceutical company who provides it. Although EAPs can represent a significant undertaking, companies who invest in them should see considerable benefit in terms of launch preparedness, relationship building and market penetration.
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 reporting the results for its clinical trial, the belief that the over-enrollment of the trial demonstrates the high interest in its novel Mazindol ER formulation, and that it is evaluating potential strategic partnerships and opportunities to potentially bring Quilience to patients as quickly as possible. 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
Alex Zwyer, CEO: +41 44 512 21 50
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
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SOURCE: NLS Pharmaceutics AG