In addition to the company's product candidates, Quilience® and Nolazol®, they have early-stage compounds that they may seek to further develop in the future.
NLS Pharmaceutics may seek to develop these other compounds, comprised of new chemical entities, or NCEs, as well as repurposed compounds, in order to advance a pipeline of product candidates at various stages of development that further complement their rare hypersomnia and complex neurodevelopmental disorder franchises. Additionally, they intend to continue to in-vest in their discovery research and development programs, with the goal of adding what they believe to be promising new compounds and indications to their drug development pipeline.
Lead Asset: Mazindol ER
Quilience® and Nolazol® are both patented and proprietary formulations 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Mazindol was marketed for nearly 30 years under the trade name Sanorex® before being voluntarily withdrawn from the market, and the drug is no longer available nor marketed in these regions.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 patients 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 Nolazol® in patients with ADHD provide evidence of the drug's favorable safety profile at doses that yielded efficacy signals.
Grab Key Sources/Details Here: Company Website.
As mentioned above, NLPS has several potential catalysts to sink your teeth into right now. Check them out:
No. 1 NLSP Potential Catalyst - This Profile's Low Float Could Create Volatile Situation (Daily)
According to the Yahoo Finance website, NLSP has a low float.
The website reports this profile to have roughly 14.18Mn shares in its float.
Why is that important? It's important on one crucial level. Volatility.
Could even more positive company news towards the end of 2023 provide a breakout spark?
No. 2 NLSP Potential Catalyst - New Regulatory Milestone Achieved Following FDA Review
NLS Pharmaceutics to Proceed with Phase 3 Clinical Program (AMAZE) for Mazindol ER for the Treatment of Narcolepsy Following FDA Review and IRB Approval of the Full Study Protocol
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."
Read the full article here.
No. 3 NLSP Potential Catalyst - Positive Results From DDI In Vitro Study Signal Positive Step Forward For Company's Lead Asset: Mazindol ER
NLS Pharmaceutics Announces Positive Safety Data From In Vitro CYP450 and Transporter Mediated Drug-Drug Interaction Studies of Mazindol
- Very low risk for drug-drug interactions (DDI) with Mazindol ER based upon results from in vitro metabolism and transporter studies
- Demonstrated pharmacological differentiation versus currently available medications used to treat narcolepsy which can have significant DDI effects preventing co-administration or requiring dose adjustments
ZURICH, SWITZERLAND / ACCESSWIRE / June 14, 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 positive data from five recently completed in vitro drug-drug interaction studies investigating the potential for DDI of mazindol, a triple monoamine reuptake inhibitor and partial orexin-2 agonist, as well as its hydrolyzed metabolite (M6). Typical DDI studies include Cytochrome P450 (CYP), UDP glucuronosyltransferase (UGT) and transporter inhibition and induction studies to evaluate whether mazindol affects the pharmacokinetic (PK) effect of other drugs (mazindol as a "perpetrator"). In addition, in vitro studies are conducted with CYP and transporter substrates to evaluate whether other drugs can affect mazindol PK (mazindol as a "victim").
Following U.S. Food and Drug Administration (FDA) guidelines, the in vitro DDI studies were designed to evaluate the drug interaction potential across a wide range of metabolic enzymes and transporters when co-administered with mazindol. The mazindol in vitro studies examined the following:
- CYP Inhibition in Human Liver Microsomes
- CYP Induction in Cultured Human Hepatocytes
- CYP and UGT Reaction Phenotyping
- UGT Inhibition in Human Liver Microsomes
- ATP-binding case (ABC) and solute carrier (SLC) Transporter Inhibition and Substrate Potential in Cells and Vesicles
Results of the in vitro perpetrator studies showed that mazindol and its hydrolysis metabolite do not have the potential to inhibit or induce the metabolism/transport of concomitant medications. Based on these in vitro data, it can be concluded that mazindol and the hydrolysis metabolite are not inhibitors of CYPs, UGTs, or transporters (including P-glycoprotein, breast cancer resistance protein [BCRP], organic anion transporter [OAT]1, OAT3 and organic cation transporter [OCT]2 and mazindol does not induce metabolism. Therefore, mazindol does not affect the PK of concomitant medications.
Results of the in vitro victim studies showed that mazindol is not metabolized by CYPs or UGTs and is not transported by BCRP, OAT1, OAT3 and OCT2. Only the hydrolysis metabolite (but not mazindol) is a P-glycoprotein (Pgp) substrate; thus a clinical DDI study of mazindol is planned to quantify the potential for an increase in the hydrolyzed metabolite (M6) exposure in the presence of a Pgp inhibitor (e.g., Itraconazole). Otherwise, concomitant medications are not expected to affect the PK of mazindol.
"We are pleased to have seen these positive results from our DDI in vitro study with mazindol, which further demonstrated its differentiated pharmacological and safety profile. This latest set of data reinforce that mazindol may have the potential to provide an advantage over other current treatments for patients with narcolepsy taking multiple drugs, including hormonal contraceptives, proton-pump inhibitors and anti-epileptic drugs, who are at higher risk of experiencing adverse drug interactions or even discontinuation of their medications due to those interactions," said George Apostol, MD, MS, Chief Medical Officer of NLS. "Based on these data, once-daily Mazindol ER shows potential to meet yet another unmet need of narcolepsy patients, in addition to its strong efficacy, fast onset of action, well demonstrated long-term safety profile, low scheduling and its unique mechanism of actions."
Read the full article here.
No. 4 NLSP Potential Catalyst - U.S. FDA Provides "Green Light" To Proceed With Phase 3 Program For Quilience® (Mazindol ER)
NLS Pharmaceutics Receives Green Light from the U.S. FDA to Proceed with Phase 3 Clinical Program (AMAZE) for Quilience(R) (Mazindol ER) for the Treatment of Narcolepsy
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.
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.
Read the full article here.
NLSP Recap - Key Potential Catalysts Could Provide This Nasdaq Profile With A Breakout Spark
No. 1 - This Profile's Low Float Could Create Volatile Situation (Daily)
No. 2 - New Regulatory Milestone Achieved Following FDA Review
No. 3 - Positive Results From DDI In Vitro Study Signal Positive Step Forward For Company's Lead Asset: Mazindol ER
No. 4 - U.S. FDA Provides "Green Light" To Proceed With Phase 3 Program For Quilience® (Mazindol ER)
Coverage is officially initiated on NLSP. When time allows, do this: