Benzinga | Oct 14, 2021 08:35AM EDT

NLS Pharmaceutics Announces Preclinical Data Demonstrating Potential Of NLS-4 In Chronic Fatigue Associated With Long-COVID

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, announces preclinical data for NLS-4 (Lauflumide), the Company's next-generation wake-promoting drug candidate, which has shown promise for the treatment of chronic fatigue associated with Long-COVID (also known as "chronic COVID syndrome").

NLS sponsored the preclinical study in which rats that had undergone a procedure to induce chronic fatigue recovered following treatment with NLS-4 and were able to exhibit typical nighttime activity when rats are normally active. Moreover, the NLS-4 treated rats had greater motor-stimulating behavior compared to rats treated with modafinil, a leading drug treatment indicated for extreme fatigue and sleepiness. Additionally, nighttime activity in NLS-4 treated rats was comparable to rats that did not undergo the fatigue procedure, the study's control group.

"The fatigue procedure utilized in this study induces a disruption in circadian activity, namely a decrease in motor activity during the dark period when rats are normally active, and an increase in motor activity during the period of light when rats are largely inactive," said Dr. Jean-Charles Bizot, Ph.D., research manager of the study and Chief Executive Officer of Key-Obs in Orl?ans, France. "In this preclinical model, we observed NLS-4's clear motor-stimulating effect, which was superior to the widely prescribed fatigue treatment, modafinil. The motor-stimulating effect of NLS-4 during the dark period suggests an improvement in recovery from the fatigue procedure and therefore is an indicator of the drug candidate's potential to treat diseases in which chronic fatigue is a primary symptom."

Improvement in stimulation of laboratory animals with NLS-4, with a beneficial effect on nictemeral rhythm, was reported in 2018 in a prior study conducted by the Department of Physiology, Faculty of Biology and Medicine, Center for Integrative Genomics, University of Lausanne, Switzerland, which concluded that NLS-4 was a highly potent wake-promoting drug that does not produce hypersomnia rebound. Additionally, the University of Lausanne study found that sleep recovery after treatment with NLS-4 is characterized by less slow-wave sleep and delta activity compared to modafinil, suggesting a lower need for recovery despite longer periods of drug-induced wakefulness. https://www.frontiersin.org/articles/10.3389/fnins.2018.00519/full

"These data provide additional evidence of the potential beneficial effects of Lauflumide (NLS-4), which produces a lower need for sleep and better recovery from fatigue by properly modulating wake-rest activity," said Eric Konofal, M.D., Ph.D., Chief Scientific Officer of NLS. "Excess fatigue, disturbed sleep and concentration are the main symptoms found in patients who have contracted COVID-19, and today, there is no known treatment for the improvement of Long-COVID symptoms. We are excited to bring this novel compound forward into clinical development, with the potential ability to offer patients diagnosed with Long-COVID the chance for relief from their chronic fatigue symptoms."