OUR NEW PROFILE IS: (NASDAQ: NLSP)
NLSP has over 100 Patents in 140 Different Countries
Jason McCarthy from Maxim Group initiated a “Buy Rating” on NLSP with a $4.00 price target back in Jan
NLSP has a low float with 14.2 Million shares coupled with a well funded cash position of $8.9Million (as of Dec. 31 2022)
NLS Pharmaceutics today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE.
— NLS Pharmaceutics (@NLSPharma) July 3, 2023
We sent you a profile last week that saw an average trade of .169 on the session.
The company announced breaking news the next morning and we saw it ROCKET all the way to .42 for a 100%+ move overnight.
We have another company that we want you to research right now for tomorrow.
Right now it is sitting back in that .80 range and has a smaller float of just over 14 Million.
Pull up NLSP right away.
NLSP is a clinical-stage pharmaceutical company 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.
CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance abuse disorders. Their discovery platform currently focuses on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. They believe that this approach may potentially offer new treatment options for patients, including those who are refractory to currently available treatments. Their current focus is in the therapeutic areas of rare hypersomnia disorders (conditions characterized by excessive daytime sleepiness, or EDS, such as narcolepsy) and complex neurodevelopmental disorders. Their drug development pipeline features our lead product candidate, Quilience®, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on drug candidate Nolazol®, for the treatment of ADHD.
- Mazindol ER has successfully completed a Phase 2 trial, including OLE, for narcolepsy treatment: projected to be $4.5B annual market by 2027**
- Orphan Drug Designation (ODD) granted in the US and Europe
- AMAZE phase 3 program starting in July 2023, secured funding for current projects and existing operations through 2025. Development of Mazindol ER is in the spotlight for progression purposes, particularly for the treatment of EDS and cataplexy in adult patients who suffer from narcolepsy
- Named Patient Program for patients suffering from idiopathic hypersomnia launched in target markets across Europe
- Key Executive Leadership roles filled
- Pipeline progressed and expanded with long-dated IP protections in major markets
- Over 100 patents in over 140 countries including technology and application for a variety of diseases such as ADHD, Cancer Fatigue, Parkinson’s and more. Not to mention that several products are nearing the end of Phase 2 and approaching NDA filing
- POLARIS: Mazindol ER Phase 2 Program in Narcolepsy, consisted of two US clinicaltrials approved by the FDA, met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. These results were promising, i.e, Sustained EDS and cataplexy improvements at all time points. OLE conclusions: 6-month OLD, displayed good subject participation (87%) and retention (11.5%)
- Partnership with Université de Lausanne (UNIL) (preclinical projects), University of Berne (narcolepsy reserach), Swiss Narcoslpsy Network (narcolepsy reserach) ( (BVF Partners L.P (financial partnership)
- Partnerships with Patient advocacy groups including Narcolepsy Network, The Narcolepsy Foundation, The Sleep Consortium, Hypersomnia Foundation, and Wake Up Narcolepsy
ZÜRICH, SWITZERLAND / ACCESSWIRE / July 3, 2023 / 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, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE. In addition, the Company is pleased to announce that the Phase 3 clinical trial protocol to evaluate the safety and efficacy of Mazindol ER in patients with narcolepsy type 1 received approval from the independent Institutional Review Board (“IRB”). The AMAZE Program will encompass two almost-identical double-blind Phase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy commencing this summer at multiple sites exclusively in the U.S.
Based on the FDA’s recommendations, both Phase 3 trials will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment and excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI) and the Epworth Sleepiness Scale (ESS).
“In addition to IRB approval of the Phase 3 study protocol for AMAZE obtained last week, with this regulatory milestone acheived, we can recruit U.S. clinical sites quickly and efficiently, allowing us to move forward with providing Mazindol ER to patients with narcolepsy type 1,” commented George Apostal, MD, MS, Chief Medical Officer of NLS.
Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study To be eligible for enrollment into the OLE study, 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 are pleased with the FDA’s review of the Phase 3 protocol and now expect to move quickly to begin enrolling patients in the AMAZE program in centers across the U.S. in the coming days.”
For more information on the AMAZE Program, please visit https://amaze.nlspharma.com/.
NLS previously reported on the Phase 2 study results in narcolepsy in which 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 showed similar efficacy with the Mazindol ER-treated patients in the randomized trial. Data from the Phase 2 studies were presented in early June at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). A recording of the Phase 2 data presentation can be found here: https://nlspharma.com/news/nls-satellite-symposium/.
An IRB operates under FDA regulations and is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure the protection of the rights and welfare of human subjects of research.
Lead Asset: Mazindol ER
Mazindol ER is a patented and proprietary formulation of the active compound mazindol, and are designed for once-daily dosing. Mazindol has a well-established safety record from its long history of clinical use in the United States and in Europe when the drug was approved in an immediate release formulation for the management of obesity. Mazindol was marketed for nearly 30 years under the trade name Sanorex® before being voluntarily withdrawn from the market, and the drug is no longer available nor marketed in these regions. During its time on the market, mazindol was also widely used off-label and prescribed under compassionate use for the treatment of narcolepsy for several decades. Use in these compassionate use programs has yielded evidence of positive efficacy in patents suffering from the symptoms of narcolepsy including patients that were refractory to approved treatments for the disorder. Additionally, these same programs, a retrospective analysis of investigator sponsored studies, and NLS’s own trial evaluating Mazindol ER in patients with ADHD provide evidence of the drug’s favorable safety profile at doses that yielded efficacy signals.
We believe that our lead product candidate, Mazindol ER, offers a differentiated profile with clincally meaningful advantages over current treatment options for narcolepsy for the following reasons:
Mechanism of action
If approved, Mazindol ER would be the only partial orexin 2 receptor agonist as well as the only triple monoamine reuptake inhibitor approved by the FDA for the treatment of narcolepsy. Narcolepsy is caused by a profound loss of orexin producing neurons. A partial orexin 2 receptor agonist may help to replace missing endogenous orexin peptide, addressing the underlying cause of the disease. In addition, the drug’s action as a triple monoamine reuptake inhibitor can further reduce disease specific symptoms, offering patients a treatment option that may address the two primary symptoms of narcolepsy – excessive daytime sleepiness (EDS) and cataplexy attacks – in a convenient once-daily oral tablet.
Low potential for abuse, misuse, and diversion.
Mazindol is currently classified by the DEA as a Schedule IV controlled substance . The DEA defines Schedule IV controlled substances as those “with a low potential for abuse and a low risk of dependence”. Unlike Xyrem® (sodium oxybate), the top-selling treatment for narcolepsy in the United States deemed to have a high potential for abuse/misuse (Schedule III), mazindol was never required by the FDA to have a risk evaluation and mitigation strategy (REMS) program in place to manage known or potential serious risks associated with its use.
Quilience® has potential to be administered as a monotherapy.
Narcolepsy is a difficult disorder to manage and even with available treatments, the majority of narcolepsy patients often require multiple medications to treat their symptoms. According to the current treatment guidelines (initially published in 2007) of the American Academy of Sleep Medicine, or AASM, medications for narcolepsy, at best, provide only moderate improvement in narcolepsy symptoms, and their respective side effects may limit their use. The AASM specifically highlights that future investigations should be directed toward more effective and better tolerated therapies for treatment. The Voice of the Patient report from the FDA’s patient-focused drug development initiative, published in 2014, concluded that, based on the overall benefit-risk assessment of current medications, there is a continued need for additional effective and tolerable treatment options for patients with narcolepsy. A retrospective analysis (Nittur et.al, Sleep Med. 2013 Jan;14(1):30-6) showed that mazindol has a long-term, favorable benefit/risk ratio in 60% of drug-resistant patients with hypersomnia, including a clear benefit on the two primary symptoms of narcolepsy–EDS and cataplexy.
Mazindol ER is being developed as a once-daily oral tablet administered in the morning upon wakening.
Patients have identified a need for treatment options that are easier to take, dosed less frequently, do not disrupt nighttime sleeping, and provide full day coverage of symptoms. We believe that once-daily dosing with Mazindol ER may address this need and may help improve patient compliance and adherence with treatment. Mazindol ER utilizes our patented and proprietary extended-release (ER) formulation and is being designed to optimize its pharmacokinetic and pharmacodynamic properties with a rapid onset of action and prolonged controlled therapeutic effect, allowing for a daily oral dose that effectively provides consistent and long-acting symptom control to uniquely meet the needs of patients.
Relationship Between Narcolepsy and ADHD
Narcolepsy and psychiatric disorders have a significant but under-recognized relationship in which the two may coexist. However, narcolepsy is frequently misdiagnosed initially as a psychiatric condition, contributing to protracted times for accurate diagnosis and treatment. Narcolepsy is a disabling neurological condition that carries a high risk for the development of social and occupational dysfunction. Deterioration in function associated with narcolepsy may lead to the secondary development of psychiatric symptoms and inversely, the development of psychiatric symptoms can lead to a deterioration in function and quality of life. The overlap in treatments may further enhance the difficulty to distinguish between diagnoses.
ADHD is the most common neurobehavioral disorder characterized by symptoms of inattention, impulsivity and hyperactivity with an estimated prevalence rate of approximately 4-12% worldwide, as reported by the paper, “Understanding Attention Deficit/Hyperactivity Disorder From Childhood to Adulthood,” by Drs. Timothy E. Wilens and Thomas J. Spencer.
On the surface, ADHD may appear to be the opposite of narcolepsy; however, there may actually be significant clinical similarities between the two disorders. Cumulative data on sleep problems in children and adolescents with ADHD have shown that children with ADHD have had a higher rate of restless sleep, impaired sleep, and daytime sleepiness than children without ADHD. However, it is unclear whether EDS in ADHD is due to nocturnal sleep disturbances or primary vigilance disorders because shorter sleep onset latency is assessed in ADHD patients by the Multiple Sleep Latency Test, rather than in the control group irrespective of the presence/absence of sleep disturbances.
Alternatively, problems with sleep may represent an intrinsic component of ADHD. The presence of ADHD symptoms in children and adolescents with narcolepsy has been found to be about two-fold higher than in the general control population. Adults with narcolepsy have been found to have a much greater likelihood of having a diagnosis of ADHD in childhood compared to the general control population. Hyperactivity seen in ADHD may, in fact, be a compensatory response for individuals who are under-aroused or sleepy, and ADHD symptoms contribute to poor quality of life and increased frequency of depressive symptoms, similar to narcolepsy. To the best of our knowledge, almost all of the treatments used in ADHD have mechanistic overlap with treatments used in narcolepsy for EDS, and researchers suggest that the symptoms of EDS, fatigue, and sleep fragmentation may be the cause for ADHD symptoms, which is consistent with similar findings in other hypersomnia disorders.
ZURICH, SWITZERLAND / ACCESSWIRE / 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 diseases.”
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.
“We are pleased 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.
NLS Pharmaceutics to Participate in the Healthcare Virtual Conference Presented by Maxim Group LLC and Hosted by M-Vest
Alex Zwyer (CEO and Founder):
Co-founder of the company, serial entrepreneur, served as COO at Viforpharma AG (global pharmaceutical company with a revenue of 1.99B in 2021) and a director since the company’s incorporation in 2015, been there since the beginning. Over 25 years of International business experience, notably when he served under Vifor International, global regulatory affairs, sales and marketing, furthermore was involved in the forefront of business development where he lead over 100 BD deals
Eric Konofal M.D. (CSO and Co-Founder):
Drug hunter and co-founder of NLS pharmaceutics, main expertise lies in his knowledge for clinical and scientific research. He’s a senior medical consultant for the Pediatric Sleep Disorders Center as well as the Principal Clinical Investigator at the Clinical Pharmacology and Pharmacogenetic Department at Robert-Debre University of Paris. Dr. Konofal has authored over 70 peer-reviewed publications in the area of sleep disorders and other CNS diseases, in fact it was Dr. Konofal that obtained the U.S. patent for mazindol (used in the treatment of ADHD), one of the key ingredients to the growth and development for the NLS pipeline (Mazindol ER Clinical Development Program.
George Apostol M.D. (CMO, Global Head R&D)
Worked in large pharma R&D organizations for more than 20 years. Broad drug development expertise across early,middle and late phases of development at the Global R&D organizations of Eli Lilly,Pfizer, Abbott, Novartis, Shire and Endo. Received distinguished R&D awards and achieved multiple regulatory approvals inUS, EU and Japan.
Keith Dewedoff (CFO)
More than 20 years of experience in the life science industry, ranging from biotech venture-backed start-ups to commercial publicly traded companies. Extensive expertise in strategic financial management, serving as CFO in organizations including Danforth Advisors, Code Bio, Ceptur Therapeutics and more than 10 other privately held and public companies at various life cycle stages.
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