NLSP NLS Pharmaceutics Ltd.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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Quilience - POLARIS
Narcolepsy
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Phase 2a
Phase 2a
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Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
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NLS-4 (lauflumide)
Chronic fatigue syndrome
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Phase 1
Phase 1
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Phase 1 clinical trial to commence in 2022.
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Sanorex (mazindol)
Obesity
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NDA Filing
NDA Filing
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Obtained full NDA package, noted November 1, 2021.
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Nolazol
ADHD
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Phase 2
Phase 2
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Phase 2 trial has been completed.
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Latest News
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ZURICH, SWITZERLAND / ACCESSWIRE / January 12, 2022 / 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 that Wake Up Narcolepsy, a leading patient advocacy organization dedicated to serving the narcolepsy community, will host an online International Narcolepsy Webinar taking place on January 20-21, 2022. NLS Pharmaceutics and other leading pharmaceutical companies focused on narcolepsy treatment are sponsors of the event, and the Company invites patients, caregivers and other interested parties to attend the webinar.
Webinar Details:
Day 1: January 20, 2022 10:45am to 3:00pm Eastern Time (4:45pm to 9:00pm CET)
Day 2: January 21, 2022 10:45am to 2:45pm Eastern Time (4:45pm to 8:45pm CET)
A presentation discussing narcolepsy generally, including a discussion of mazindol as a potential treatment for narcolepsy and NLS Pharmaceutics' ongoing phase 2 clinical trial for Quilience® (mazindol ER) will take place on January 20, 2022 at 12:45pm ET (6:45pm CET). To join the webinar, please visit: https://www.wakeupnarcolepsy.org/news/international-narcolepsy-webinar/
About Wake Up Narcolepsy
Wake Up Narcolepsy is a 501(c)(3) not-for-profit organization dedicated to driving narcolepsy awareness, education, and research toward improved treatments and a cure. Established in 2008, it has quickly become a national leader for narcolepsy research and awareness, as it is dedicated to funding research into the causes, prevention, treatments and a cure for narcolepsy while increasing awareness amongst the public. Every year, Wake Up Narcolepsy hosts various awareness-driven events and makes substantial contributions to cutting-edge narcolepsy research. For more information, please visit: https://www.wakeupnarcolepsy.org/
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 2 study in the U.S. evaluating Quilience® in adult subjects suffering from narcolepsy is currently being conducted. 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 express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses mazindol as a potential treatment for narcolepsy and being potentially developed for other sleep-wake disorders such as idiopathic hypersomnia. 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 filed with the SEC, which is available on the SEC's website, www.sec.gov .
Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
Media Contact
Pascal Nigen: +1 917-385-2160
Alpha Bronze, LLC
www.nlspharmaceutics.comSOURCE: NLS Pharmaceutics Ltd.
View source version on accesswire.com:
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- Key patent now granted in major markets including the U.S., Europe, Canada & South Korea
- Patent claims cover use of the Company's lead product candidate, Quilience® (mazindol ER) in both attention deficit hyperactivity disorder (ADHD) & narcolepsy
STANS, SWITZERLAND / ACCESSWIRE / January 4, 2022 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that the United States Patent and Trademark Office (USPTO) has granted the Company U.S. Patent No. 11207271, entitled A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). The patent covers oral formulations containing immediate-release and sustained-release layers of mazindol and their use in treating attention deficit disorders (ADD or ADHD), related deficit of alertness or decline of vigilance, or excessive daytime sleepiness including narcolepsy or idiopathic hypersomnia.
"Our intellectual property estate has been significantly strengthened since our initial public offering in February 2021, putting NLS in a solid position as we anticipate reporting Phase 2a results for Quilience® (mazindol ER) to treat narcolepsy in the first quarter of 2022," said Alex Zwyer, Chief Executive Officer of NLS. "We now have issued patents in major markets including the U.S., Europe, Canada, and South Korea covering our extended-release formulation of mazindol. These recently issued patents augment the Orphan Drug Designations that have been granted for Quilience® in both the U.S. and Europe. Most patients with narcolepsy remain unsatisfied with current treatment options, and we believe that Quilience® has potential to fill a major need in the market given mazindol's history of safety and evidence of effectiveness in treating the symptoms of narcolepsy. We remain focused on bringing this treatment option to patients suffering from narcolepsy and potentially other sleep-wake disorders as soon as possible."
About NLS Pharmaceutics Ltd.
NLS Pharmaceutics 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. 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. NLS has initiated a phase 2 program in the U.S. evaluating Quilience® in adult subjects suffering from narcolepsy. 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 one-third of narcoleptic patients are also diagnosed with ADHD.Safe Harbor Statement
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the timing of the reporting of its reporting of the Phase 2a results for Quilience® (mazindol ER) to treat narcolepsy and that Quilience® has potential to fill a major need in the market. 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's products may not be approved by regulatory agencies, NLS's 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's process; NLS's 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's patents may not be sufficient; NLS's 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 filed with the Securities and Exchange Commission (the SEC"), which is available on the SEC's website, www.sec.gov.Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00Investor Relations Contact
Cindy Rizzo: +1 908-229-7050Media Contact
Pascal Nigen: +1 917-385-2160
Alpha Bronze, LLC
www.nlspharma.comSOURCE: NLS Pharmaceutics AG
View source version on accesswire.com:
https://www.accesswire.com/680768/NLS-Pharmaceutics-Announces-Patent-Issuance-in-the-United-States-for-its-Mazindol-Extended-Release-Formulation
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STANS, SWITZERLAND / ACCESSWIRE / November 30, 2021 / 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 final results from a preclinical study for NLS-4 (Lauflumide), the Company's next-generation wake-promoting drug candidate. Based on the results, the Company believes that NLS-4 offers promise to become a foundational treatment for the chronic fatigue associated with the symptoms of Long-Covid (also known as "Chronic Fatigue caused by Covid-19 infection").
The aim of the study was to examine the effectiveness of NLS-4 in comparison with modafinil, a widely-used first-line wake-promoting treatment. NLS-4 is designed to be a more potent next-generation modafinil that does not induce the hepatic toxicity associated with long-term modafinil use. In the study's Long-Covid animal model, NLS-4 improved circadian rhythm dysregulation and chronic fatigue syndrome (CFS) in subject animals. Based on the results, the Company believes that NLS-4 should improve recovery from CFS in humans at a dose that is four times lower than that used for modafinil.
NLS had previously communicated that Sprague-Dawley rats subjected to a fatigue procedure for 7 days that induced CFS recovered with NLS-4 treatment, and were able to exhibit typical nighttime activity when rats are normally active. The final results confirm that NLS-4 treatment produced an increase in locomotor activity which may reduce the impairment of circadian rhythm at doses four times lower than modafinil. In the study, nighttime activity in NLS-4 treated rats was observed to be comparable to rats that did not undergo the fatigue procedure, the study's control group.
An increasing proportion of Covid-19 patients are suffering from prolonged symptoms that are typically found in patients diagnosed with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). However, the effects of current treatments proposed for this condition have been inconclusive.
"We believe that these final results from this cutting-edge preclinical study confirm that NLS-4 (Lauflumide) expressed motor-stimulating effects, which are superior to the widely prescribed fatigue treatment, modafinil at all doses. The ability of Lauflumide to enable rats that have undergone the fatigue procedure to recover is a strong indicator of the drug's potential to treat diseases in which CFS is a key symptom," said Eric Konofal, MD, Chief Scientific Officer of NLS Pharmaceutics. "The fatigue procedure induced a decrease in body weight, and therefore we also examined the weight growth curve in rats treated by NLS-4 at its lowest doses. Importantly, weight loss was not modified by NLS-4 (16 mg/kg). Stimulants commonly prescribed off-label to treat fatigue symptoms decrease appetite and weight loss is a common side effect, whereas Lauflumide at low doses did not cause these issues."
"Excessive fatigue, daytime sleepiness, deficit of alertness and disturbed sleep are some of the main symptoms found in patients who have contracted Covid-19, and today, there is no approved therapeutic agent for the improvement of the CFS associated with Long-Covid," said Alex Zwyer, Chief Executive Officer of NLS Pharmaceutics. "We look forward to advancing the development of NLS-4, as the unmet medical need for improved fatigue treatments is growing with more patients surviving infection with Covid-19 and its variants."
About NLS-4 (Lauflumide) and its pre-clinical safety profile
NLS-4 (Lauflumide) is a next-generation selective dopamine reuptake inhibitor. Contrary to modafinil treatment, which can cause hepatic enzyme induction with repeated dosing, NLS-4 did not induce cytochrome P450 (CYP) enzymes, including CYP3A4/5 when tested in human cell cultures.NLS believes that NLS-4 is the only wake-promoting compound without any rebound hypersomnia. This "hypnolytic effect" of NLS-4 is thought to be due to the compound's ability to prevent increased sleep need following sleep loss as supported by the final pre-clinical results.With the promising results from the cutting-edge preclinical fatigue study in animals, and the apparent absence of CYP450 enzyme induction, NLS-4 appears to have a superior profile compared to the widely used drug modafinil, and potentially represents an important milestone in the development of this next generation wake-promoting agent.
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. 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. NLS has recently initiated a phase 2 study in the U.S. evaluating Quilience® in adult subjects suffering from Narcolepsy. 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 express 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, superiority and safety of NLS-4 and its potential to become a treatment for the chronic fatigue associated with the symptoms of Long-Covid. 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 filed with the SEC, which is available on the SEC's website, www.sec.gov.
Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00
Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
SOURCE: NLS Pharmaceutics AG
View source version on accesswire.com:
https://www.accesswire.com/675231/NLS-Pharmaceutics-Announces-Preclinical-Results-Confirming-the-Potential-Benefit-and-Safety-Profile-of-NLS-4-for-Circadian-Rhythm-Dysregulation-and-Chronic-Fatigue-Syndrome-in-Long-Covid-Model
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STANS, SWITZERLAND / ACCESSWIRE / November 1, 2021 / 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 (CNS) disorders with high unmet medical need, announces that its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:
To Our Shareholders and Friends,
I am pleased to report on the progress that NLS has made this year as we advance toward building a valuable company that serves patients suffering from rare and debilitating CNS disorders. Since the closing of our initial public offering (IPO) in February, we have moved swiftly into our Phase 2 clinical program for Quilience®, our lead product candidate for the treatment of narcolepsy. This remains a top priority for the Company as we believe that our novel extended-release formulation of mazindol has the potential to transform the way narcolepsy is treated. Assuming our clinical programs for this drug candidate are successful, and that we receive marketing authorization, we anticipate that key competitive advantages for Quilience will include symptom control with once-daily morning dosing, the potential to be used as a monotherapy given mazindol's multi-modal mechanism of action, a favorable safety and tolerability profile, and the potential to retain mazindol's Schedule IV designation. These differentiating properties are anticipated to offer meaningful clinical benefit and advantages to patients diagnosed with either narcolepsy Type 1 or Type 2, underscoring our belief that Quilience will become a best-in-class therapeutic option.
With the ability to test Quilience in other sleep-wake disorders such as idiopathic hypersomnia (IH) and obstructive sleep apnea (OSA), the franchise potential for this product candidate is also something we expect to explore longer-term to build additional value.
Other accomplishments since our IPO include obtaining the full New Drug Application (NDA) package for Sanorex, Novartis' commercial brand name for mazindol, when it was marketed for the treatment of obesity. We believe that having proprietary rights in the U.S. to this comprehensive data package provides valuable information and insights as we move this repurposed compound through clinical development and ultimately into regulatory reviews. Importantly, we obtained patent issuances for our mazindol ER formulation in both Europe and Canada earlier this year, and in August, the U.S. Patent and Trade Office issued a notice of allowance for our pending patent application. We used part of the IPO proceeds to pay off all of the Company's debts to ensure a clean capital structure, and we worked diligently to submit our Investigational New Drug (IND) application and receive approval from U.S. regulators to advance Quilience into our ongoing Phase 2a clinical trial. The clinical development program for Quilience is named "POLARIS", the synonym for the North Star used as a reference point in navigation.
Recently, we reported positive pre-clinical data for NLS-4 (lauflumide), our new chemical entity designed as a next-generation modafinil to address sleep-wake disorders such as chronic fatigue syndrome. Our pre-clinical data suggest that NLS-4 could be used to treat the fatigue associated with long COVID syndrome, and we intend to advance this compound into clinical development ourselves or with a partner in 2022.
We believe that Quilience's multi-modal mechanism of action is highly unique, offering the stimulant properties of monoamine reuptake inhibition, as well as the ability to treat the symptoms of narcolepsy at its root cause by activating orexin receptors. Targeting the orexin pathway is a major focus in the field, given the orexin deficiency observed in narcolepsy patients that experience debilitating symptoms including cataplexy, which is a spontaneous loss of muscle tone. We believe that NLS has taken the lead in developing the first orexin-targeted therapy for narcolepsy, as a leading big pharma competitor recently announced that it has halted Phase 2 development of its pure orexin agonist compound while it evaluates a safety signal. With mazindol's long history of safety and tolerability as a commercial product, we are confident in Quilience's ability to safely and effectively target the underlying cause of narcolepsy.
As we advance the ongoing Phase 2a trial comparing Quilience to placebo to treat the core symptoms of narcolepsy, we have offered patients the option to roll into a 6-month open label extension (OLE) study, enabling trial participants to remain on Quilience free of charge for an additional half year. The OLE study is an important incentive for patients to sign up for the Phase 2a trial, and I am pleased to report that we already have patients electing and entering the OLE portion of the study. We are also pleased with the pace of enrollment thus far, as the competitive environment for enrolling patients in narcolepsy clinical trials can be challenging. Given the competitive landscape and that our application for the setup of the OLE study took slightly longer than expected, we now anticipate reporting interim top-line results for POLARIS in the first quarter of 2022. We are looking forward to reporting these results, as they will represent the first prospective clinical trial results for mazindol ER in the treatment of narcolepsy.
Now that we have taken NLS public, capitalized the business to achieve a key inflection point with our lead program, and staffed the Company with a high-performance team, I believe that we are in good position to accomplish our key near-term objectives. Activities and events that we anticipate delivering though the end of this year and in 2022 include: final granting of our U.S. patent protecting Quilience's novel once-daily formulation; an investigator presentation at the Wake Up Narcolepsy patient advocacy webinar in November highlighting Quilience and our ongoing Phase 2a clinical program; potential partnering of pipeline products such as NLS-4 and Nolazol for ADHD outside the U.S.; initiating early access programs for Quilience in certain countries with the potential to generate non-dilutive, pre-approval revenue; and reporting top-line results for Quilience in the treatment of narcolepsy.
Given these initiatives, it remains a busy time at NLS, and we are extremely excited about the near-and long-term prospects of the Company. I would like to thank our clinical investigators and their patients for participating in the POLARIS trial to evaluate Quilience's clinical profile and its potential as a class-leading treatment for narcolepsy. I would also like to thank our shareholders for their continued support of the Company. I wish all of our stakeholders a happy and healthy year-end, and we look forward to providing additional updates on our progress in the coming months and quarters.
Sincerely,
Alex Zwyer
Chief Executive OfficerAbout 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. 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. NLS has recently initiated a phase 2 study in the U.S. evaluating Quilience® in adult subjects suffering from Narcolepsy. 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 1/3rd of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS is using forward-looking statements when it discusses the competitive advantages for Quilience, subject to obtaining regulatory approvals, the benefits of acquiring the NDA package for Sanorex from Novartis, its intention to advance NLS-4 for the potential treatment of long COVID either into clinical development ourselves or with a partner in 2022, the belief that it has taken the lead in developing the first orexin-targeted therapy for narcolepsy, the expected timing of the reporting of interim top-line results for POLARIS and its near term goals for the remainder of 2021 and 2022. 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 filed with the SEC, which is available on the SEC's website, www.sec.gov.
Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00Investor Relations Contact
Cindy Rizzo: +1 908-229-7050
www.nlspharmaceutics.comSOURCE: NLS Pharmaceutics AG
View source version on accesswire.com:
https://www.accesswire.com/670375/NLS-Pharmaceutics-CEO-Issues-Letter-to-Shareholders
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STANS, SWITZERLAND / ACCESSWIRE / October 14, 2021 / 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 Orléans, 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."
About NLS-4 and Fatigue Symptoms Associated with Viral Pandemics
NLS-4 is Lauflumide [2 - ((bis (4-fluorophenyl) methyl) sulfinyl) acetamide], a next-generation selective dopamine reuptake inhibitor. NLS-4 is an enantiomeric form (R-isomer) that is optically pure with an enantiomeric excess of more than 95% of bis (p-fluoro) phenyl ring-substituted derivative of modafinil (USPTO Patent Application 20130295196, Lauflumide and the enantiomers thereof, method for preparing same and therapeutic uses thereof: patent granted, 2017).
NLS-4 was found to weakly bind with neuropeptide Y1 (NPY1), as a reverse agonist inhibitor modulating the development of depressive-like behavior and exerting histamine-2 receptor activity, potentially alleviating neurocognitive disorders. A recent complementary assay profile has demonstrated that NLS-4 may exert inhibitory activity on ACE2 and Cathepsin L, which offers potential promising treatment for COVID-19 patients.
It is important to recall that in the aftermath of the pandemic of viral influenza with lethargic encephalitis, which had prevailed in Europe from 1915 to 1926, psychostimulants (amphetamine salts) had been adopted as symptomatic treatment for neurological conditions caused by the virus. Amphetamines exhibited their beneficial effects on the brain, attention, and fatigue in the patients who received them for treatment. Today, with the Covid-19 pandemic, we are seeing the emergence of a new form of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) called Long-COVID.
NLS is committed to initiating clinical development of NLS-4 for the treatment of Long-COVID. The claim of this invention by patent application has been registered under number EP21305944.
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. 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. NLS has recently initiated a phase 2 study in the U.S. evaluating Quilience® in adult subjects suffering from Narcolepsy. 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 1/3rd of narcoleptic patients are also diagnosed with ADHD.
Safe Harbor Statement
This press release contains express 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 NLS-4 (Lauflumide) for sufferers of Long-COVID and its commitment to initiating clinical development of NLS-4 for the treatment of Long-COVID. 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 filed with the SEC, which is available on the SEC's website, www.sec.gov.
Corporate Contact
Alex Zwyer, CEO: +41 41 618 80 00Investor Relations Contact
Cindy Rizzo: +1 908-229-7050SOURCE: NLS Pharmaceutics AG
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