West Nile virus (WNV) is a mosquito-borne virus which in majority of cases causes only self-limited disease.
Despite that, in minority of cases (
0.5%) it can infect the brain and cause severe and even life-threatening disease (neuroinvasive disease).
Recent study has shown that up to 40% of WNV patients who develop neuroinvasive disease, have antibodies against Interferons (anti-Type I interferon autoantibodies), which neutralizes interferons, and could explain the development of severe disease.
The investigators therefore assume that early treatment with interferon beta (the type of interferon against which most patients do not have neutralizing antibodies) could prevent the development of severe neuroinvasive WNV disease.

Start Date14 Jul 2024

Sponsor / Collaborator

Tel Aviv Sourasky Medical Center

NCT06053749

/ Active, not recruitingNot Applicable

INFORM - Interferon-Beta Exposure in the 2nd and 3rd Trimester of Pregnancy - a Register-Based Drug Utilisation Study in Finland and Sweden

Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

Start Date20 Mar 2024

Sponsor / Collaborator

Bayer AG

[+3]

NCT06019130

/ RecruitingPhase 2IIT

Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma

The purpose of this study is to assess whether the addition of the immune checkpoint inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a complete response on MRI and PET after 3 cycles of induction therapy.

Start Date10 Jan 2023

Sponsor / Collaborator

Deutsche Krebshilfe gGmbH

100 Clinical Results associated with INTERFERON BETA-1A(Merck Serono SA)

100 Translational Medicine associated with INTERFERON BETA-1A(Merck Serono SA)

100 Patents (Medical) associated with INTERFERON BETA-1A(Merck Serono SA)

1,552

Literatures (Medical) associated with INTERFERON BETA-1A(Merck Serono SA)

25 Feb 2025·NEUROLOGY

Long-Term Treatment With Ocrelizumab in Patients With Early-Stage Relapsing MS

Article

Author: Chognot, Cathy ; Kulyk, Inessa ; Cree, Bruce A.C. ; Havrdová, Eva K. ; Mandel, Corey R. ; Berthele, Achim ; Traboulsee, Anthony ; Cerqueira, João J. ; Filippi, Massimo ; Bernasconi, Corrado ; Ziemssen, Tjalf ; Schneble, Hans-Martin ; Vollmer, Timothy ; Thanei, Gian-Andrea ; Pearson, Owen R. ; Raposo, Catarina ; Incera, Elodie ; Pardo, Gabriel

BACKGROUND AND OBJECTIVES:

Patients with multiple sclerosis (MS) may demonstrate better disease control when treatment is initiated on high-efficacy disease-modifying therapies (DMTs) from onset. This subgroup analysis assessed the long-term efficacy and safety profile of the high-efficacy DMT ocrelizumab (OCR) as first-line therapy for early-stage relapsing MS (RMS).

METHODS:

Post hoc exploratory analyses of efficacy and safety were performed in a subgroup of treatment-naive patients with RMS who received ≥1 dose of OCR in the multicenter OPERA I/II (NCT01247324/NCT01412333) studies. Patients were randomized to OCR or interferon β-1a for 96 weeks (double-blind controlled treatment period [DBP]), before switching to OCR in the open-label extension (OLE). Efficacy assessments included no evidence of disease activity (NEDA-3), 24-week confirmed disability progression (CDP), MRI lesion activity, change in whole-brain volume; with safety outcomes assessed over a 9-year treatment period.

RESULTS:

Overall, 757 patients were included (interferon-treated n = 382, mean age 36.3 years, 65.7% female; OCR-treated n = 375, mean age 35.5 years, 64.0% female); 505 of 757 (66.7%) completed 9 years of follow-up. The difference in NEDA status between OCR-treated and interferon-treated patients achieved during the DBP (72.5% and 43.8%, respectively, odds ratio 3.48, 95% CI 2.52-4.81) was maintained throughout the 7-year OLE (48.2% vs 25.7%; odds ratio 2.72, 95% CI 1.94-3.82). No 24-week CDP was observed in 78.7% of OCR-treated patients over 9 years. Brain volume loss over the entire study period remained numerically higher among patients starting OCR later (p = 0.09 at OLE at week 336). During the DBP, safety profiles in both groups were similar; no new safety signals were observed during the OLE. Over >9 years of continuous OCR treatment, the rate of infections remained low and stable over time.

DISCUSSION:

A higher proportion of OCR-treated patients achieved NEDA status compared with interferon-treated patients during the DBP, which was maintained throughout the OLE. After switching to OCR, disability accrual and brain volume loss among interferon-treated patients became similar to the OCR-OCR group, but disability and brain volume loss accrued during interferon treatment were not recovered. Possible study limitations include assessment bias due to unmaintained blinding during the OLE. These data support OCR as first-line therapy for these patients.

CLASSIFICATION OF EVIDENCE:

This study provides Class II evidence that OCR delays disease progression in treatment-naïve patients with early-stage RMS.

01 Dec 2024·Journal of Central Nervous System Disease

Five-year efficacy outcomes of ocrelizumab in relapsing multiple sclerosis: A propensity-matched comparison of the OPERA studies with other disease-modifying therapies in real-world lines of treatments

Article

Author: Bergmann, Arnfin ; Model, Fabian ; van Hövell, Philip ; Craveiro, Licinio ; Heer, Yanic ; Yiu, Sean ; Bernasconi, Corrado ; Muros-Le Rouzic, Erwan ; Tozzi, Viola ; Braune, Stefan

Background:

Clinical trials comparing the efficacy of ocrelizumab (OCR) with other disease-modifying therapies (DMTs) other than interferon (IFN) β-1a in relapsing multiple sclerosis (RMS) are lacking.

Objectives:

To compare the treatment effect of OCR vs six DMTs’ (IFN β-1a, glatiramer acetate, fingolimod, dimethyl fumarate, teriflunomide, natalizumab) treatment pathways used in clinical practice by combining clinical trial and real-world data.

Methods:

Patient-level data from OPERA trials and open-label extension phase, and from the German NeuroTransData (NTD) MS registry, were used to build 1:1 propensity score-matched (PSM) cohorts controlling for seven baseline covariates, including brain imaging activity. Efficacy outcomes were time to first relapse and time to 24-week confirmed disability progression over 5.5 years of follow-up. Intention-to-treat analysis using all outcome data irrespective of treatment switch was applied.

Results:

The analyses included 611 OPERA patients and 7141 NTD patients. We built 12 paired-matched cohorts (six for each outcome, two for each DMT) to compare efficacy of OCR in OPERA with each DMT treatment pathway in NTD. Post-matching, baseline covariates and PS were well balanced (standardized mean difference <.2 for all cohorts). Over 5.5 years, patients treated with OCR showed a statistically significant reduction in the risk of relapse (hazard ratios [HRs] .30 to .54) and disability progression (HRs .51 to .67) compared with all index therapies and their treatment switching pathways in NTD. Treatment switch and/or discontinuation occurred frequently in NTD cohorts.

Conclusion:

OCR demonstrates superiority in controlling relapses and disability progression in RMS compared with real-world treatment pathways over a 5.5-year period. These analyses suggest that high-efficacy DMTs and high treatment persistence are critical to achieve greatest clinical benefit in RMS.

Registration:

OPERA I (NCT01247324), OPERA II (NCT01412333)

01 Nov 2024·Journal of Managed Care & Specialty Pharmacy

Patient-reported disability progression outcomes among patients with multiple sclerosis: Results of an outcomes-based agreement

Article

Author: Good, Chester B. ; Alderson, Jacqueline ; Maxwell, RaeAnn ; Swart, Elizabeth C.S. ; Peasah, Samuel K. ; Manolis, Chronis

BACKGROUND:

Outcomes-based agreements (OBAs) are agreements between payers and manufacturers in which payment for medications is tied to patient outcomes. These contracts aim to measure the value of prescription medications on predefined clinical indicators in real-world patient populations. OBAs are gaining traction in the United States as the health care industry shifts from volume-based to value-based care. Multiple sclerosis (MS) is an appealing therapeutic area for OBAs because of its prevalence, high cost of medications, and multiple effective therapeutic options.

OBJECTIVE:

To describe findings from an OBA that was prospectively conducted in a large regional health system for patients with MS taking interferon β-1a or dimethyl fumarate.

METHODS:

In this prospective real-world analysis, commercial or health insurance exchange members were included based on the parameters of the OBA. Disability progression was assessed using a patient-reported outcome, patient-determined disease steps (PDDS). In the OBA, members aged 18 years or older with an MS diagnosis were included in the contract. A baseline score was collected for eligible members, with follow-up scores occurring between a 90-day and 180-day postbaseline score. If a follow-up score was greater than the baseline score, a subsequent PDDS score was collected between 90-days and 120-days to determine if the PDDS score remained elevated, indicating that the member had disability progression.

RESULTS:

During the contract period, 410 patients were eligible for PDDS collection, with 241 and 169 patients in the dimethyl fumarate and interferon β-1a cohorts, respectively. There were 162 patients who were lost to follow-up, and 64 patients who were ineligible per contract parameters. Of the remaining 184 eligible patients (107 on dimethyl fumarate and 77 on interferon β-1a), 21 (11%) patients had confirmed disability progression (6 on dimethyl fumarate [5.6%] and 15 on interferon β-1a [19.5%]).

CONCLUSIONS:

Our findings suggest that meaningful patient-reported outcomes, such as disability progression, can be operationalized in an innovative OBA.

News (Medical) associated with INTERFERON BETA-1A(Merck Serono SA)

28 Jan 2025

·www.prnewswire.com

NLS Pharmaceutics Announces the Launch of a Preclinical Program for Mazindol ER in the Treatment of Fentanyl Dependence

Centers for Disease Control and Prevention (the "CDC") reported 105,007 drug overdose deaths - with 90% involving synthetic opioids like fentanyl Mazindol ER potentially offers a non-opioid alternative, addressing the underlying neurochemical imbalances associated with fentanyl addiction. Mazindol ER is patent protected beyond September 2038 ZURICH, Jan. 28, 2025 /PRNewswire/ -- NLS Pharmaceutics Ltd. (NASDAQ: NLSP) (NASDAQ: NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company dedicated to developing therapies for rare and complex central nervous system disorders, is proud to announce the launch of a preclinical program evaluating Mazindol ER (Extended-Release) as a novel treatment for fentanyl dependence. Fentanyl dependence is a major global health crisis and was recently declared a national public health emergency by the new Trump administration. In 2023, the CDC reported 105,007 drug overdose deaths with 90% involving synthetic opioids like fentanyl. "The opioid epidemic, and specifically the rise of fentanyl dependence, presents an urgent medical need for innovative, non-opioid treatment approaches," said Alex Zwyer, Chief Executive Officer of NLS. "We are committed to exploring the unique pharmacological profile of Mazindol, which targets multiple neurotransmitter systems implicated in opioid addiction. This preclinical program represents an important step in developing a potentially transformative therapy." Highlights of the Preclinical Program Mazindol, a tetracyclic compound with a distinct pharmacological profile, has shown potential in mitigating opioid dependence by acting on multiple neurotransmitter pathways, including: 5-HT1A receptor modulation: Regulates mood, anxiety, and reward pathways, addressing psychological aspects of opioid withdrawal. Mu-opioid receptor ("MOP") interaction: Provides partial modulation of opioid effects, potentially reducing cravings and withdrawal symptoms without reinforcing addiction. Orexin-2 receptor ("OX2R") partial agonist: Aids in restoring sleep-wake cycles and enhancing cognitive stability, which are significantly disrupted during opioid withdrawal. Scientific Rationale Fentanyl, a synthetic opioid that is up to 50 times more potent than heroin, has driven a global health crisis due to its high abuse potential and severe withdrawal symptoms. Traditional treatments, such as methadone and buprenorphine, often come with limitations, including risk of dependence and regulatory hurdles. Mazindol ER offers a potential non-opioid alternative, addressing the underlying neurochemical imbalances associated with fentanyl addiction while supporting recovery through its multimodal action on neurotransmitter systems. The sustained-release formulation provides a long-acting therapeutic effect, improving patient compliance and minimizing withdrawal-related disruptions. Mechanism of Action of Mazindol ER Mazindol's unique pharmacodynamic properties position it as a promising candidate for opioid dependence treatment. Its mechanisms include: Inhibition of dopamine and norepinephrine transporters, restoring neurochemical balance and reducing cravings. 5-HT1A receptor modulation, potentially alleviating anxiety and depressive symptoms associated with withdrawal. MOP agonist activity, which may help mitigate opioid withdrawal symptoms while preventing full opioid reinforcement. Partial OX2R agonist activity, aiding in circadian rhythm regulation and reducing the impact of opioid-induced sleep disturbances. Preclinical Study Objectives and Next Steps The preclinical study, designated Study KO-943, will focus on: Evaluating the safety and efficacy of Mazindol ER in fentanyl dependence models. Assessing pharmacokinetics and pharmacodynamics in opioid-exposed subjects. Exploring the impact of Mazindol ER on craving reduction, withdrawal mitigation, and cognitive performance. The study is expected to be completed within 12-18 months. Upon successful results, NLS will potentially seek regulatory pathways to advance to clinical development. "We believe that Mazindol ER could offer a paradigm shift in opioid addiction treatment," added Dr. Konofal, M.D./PhD, Chief Scientific Officer of NLSP. "Our stepwise development plan prioritizes early-stage investment to generate critical data that will pave the way for larger-scale studies and potential commercialization opportunities." Existing Patent Portfolio NLS Pharmaceutics has secured several patents supporting the development of Mazindol ER: United States Patent No. 11,207,271: Covers oral formulations containing immediate-release and sustained-release layers of mazindol and their use in treating attention deficit disorders ("ADHD") as well as sleep disorders. United States Patent No. 11,596,622: Granted for the use of Mazindol ER in the treatment of heroin dependence, providing a new therapeutic strategy for opioid use disorder. These patents strengthen the Company's intellectual property position and support the ongoing development of Mazindol ER for various indications. Future Outlook NLS aims to utilize initial findings to expanded research and potential commercialization of Mazindol ER in the treatment of fentanyl dependence. Other pipeline candidates include: NLS-4 (Lauflumide): A wake-promoting agent with applications in military and emergency response. NLS-11 (Benedin): A circadian rhythm modulator with potential applications for space missions and the ultra-rare Kleine-Levin Syndrome (KLS). NLS-3 (Levophacetoperane SR): A novel treatment for ADHD and Autism Spectrum Disorders, with potential pro-drug development. About NLS Pharmaceutics Ltd. NLS is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders who have unmet medical needs. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. NLS has recently filed a Registration Statement on Form F-4 with the U.S. Securities and Exchange Commission (the "SEC"), outlining the details of the proposed merger between NLS and Kadimastem (the "Merger"). Kadimastem is a leading clinical stage cell therapy company, developing "off-the-shelf", proprietary cell products including human pancreatic islet-like cells capable of secreting insulin to generate an innovative treatment intended for the potential cure of type 1 diabetes. Following the Merger, NLS and Kadimastem expect to continue developing NLS's promising, first-in class Dual Orexin Agonist platform within the combined company. The remaining NLS assets are expected to be divested subject to a contingent value rights agreement, the proceeds of which will be distributed entirely to the current shareholders of NLS. For more information, please visit . About Kadimastem Kadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications. IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of Kadimastem and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST). 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 use of Mazindol as a potential novel treatment for fentanyl dependence, regulatory approval timelines, clinical trial outcomes, market acceptance and its expected preclinical program. Further, NLS and Kadimastem are using forward-looking statements when they discuss the expected closing of the transaction and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders, as well as the expected strategic position of the combined company following the merger, if completed. These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem 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: risks related to the combined company's or NLS's ability to have future successful meetings with the FDA; risks related to the companies' ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed merger or resulting from the trial or preclinical program and potential adverse reactions or changes to business relationships resulting from the announcement of the trial or preclinical program; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies' products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; 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; the companies' patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any 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's annual report on Form 20-F for the year ended December 31, 2023, filed with the SEC, which is available on the SEC's website, , and in subsequent filings made by NLS with the SEC, including under the heading "Risk Factors" in NLS's registration statement on Form F-4, filed with the SEC on December 27, 2024. No Offer or Solicitation This communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Additional Information about the Transaction and Where to Find It In connection with the proposed transaction, NLS has filed a Registration Statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or any other document that NLS may file with the SEC. The proxy statement (if and when available) will be mailed or delivered to shareholders of NLS and Kadimastem. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at . Copies of the documents filed with the SEC by the Company will be available free of charge on NLS's website at . Participants in the Solicitation NLS, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS's Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above. NLS Contacts: [email protected] Kadimastem Contacts: Sarah Bazak, Investors relations [email protected] SOURCE NLS Pharmaceutics Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Cell Therapy

19 Dec 2024

·www.accesswire.com

NLS Pharmaceutics and Kadimastem Announce the Submission of a Request by Kadimastem and iTolerance, Inc. for an FDA Pre-IND Meeting for an Innovative Breakthrough Type 1 Diabetes Treatment

This submission comes after successful INTERACT meeting with the FDA earlier this year.NLS Pharmaceutics and Kadimastem working to close merger by the end of January 2025 ZURICH, SWITZERLAND AND NESS ZIONA, ISRAEL / ACCESSWIRE / December 19, 2024 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP) and Kadimastem Ltd. ("Kadimastem"), a clinical-stage company specializing in "off-the-shelf" allogeneic cell therapy products for neurodegenerative diseases and diabetes, announced today in collaboration with iTolerance, Inc, ("iTolerance") a Miami-based regenerative medicine company, that a request for a Pre-Investigational New Drug ("Pre-IND") meeting has been submitted by Kadimastem and iTolerance to the U.S. Food and Drug Administration ("FDA") for iTOL102, an investigational biologic consisting of allogenic human stem cell-derived pancreatic islets combined with an immunomodulator for the treatment of Type 1 Diabetes. Kadimastem believes that this collaboration signifies a potentially transformative step in diabetes treatment.This submission comes after a successful INTERACT ("Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products") meeting, which is a meeting at a specific time early in the product development, between Kadimastem, iTolerance, and the FDA earlier this year. The submission is a significant milestone toward the clinical development of iTOL102, an on-going collaborative research initiative between iTolerance and Kadimastem, funded in part by the Israel-United States Binational Industrial Research and Development Foundation ("BIRD"). iTOL102 combines iTolerance's proprietary SA-FasL microgel (known as iTOL-100), an immune modulator, and IsletRx, insulin-producing islet cells derived from human pluripotent stem cells, to generate an innovative treatment intended for the potential cure of type 1 diabetes.iTOL-100, an immunomodulatory microgel technology being developed by iTolerance is designed to reduce or eliminate the need for life-long chronic systemic immunosuppression following transplantation of allogenic cells. In a preclinical diabetic rodent model designed by iTolerance, iTOL-100 was shown by iTolerance to be compatible with Kadimastem's IsletRx human stem cell-derived islets.Kadimastem's IsletRx is a clinical-grade product comprising human pancreatic islet-like cells capable of secreting insulin. IsletRx, a preparation of human stem cell-derived islets developed by Kadimastem, is a scalable and virtually unlimited source of insulin-producing cells which could address the critical shortage of donor islets for transplantation. This innovative therapy may effectively detect glucose levels in the body and produce the necessary amounts of insulin and glucagon.The iTOL102 product was evaluated at the fast-track center for testing at the Diabetes Research Institute ("DRI") at the University of Miami School of Medicine, where it was designated by DRI to be a novel combination of tolerance-inducing agent and human stem cell-derived islets demonstrating functional insulin release and disease reversal in an animal model.Ronen Twito, Executive Chairman and Chief Executive Officer of Kadimastem, stated, "This requested Pre-IND meeting is a crucial step in our development of iTOL 102 and towards bringing this potential breakthroughtherapy to the market. We are committed to advancing our innovative IsletRx cell product and are excited about the potential of combining it with iTolerance's immunomodulatory technology to create a potential cure for Type 1 diabetes."iTolerance Chief Executive Officer, Dr. Anthony Japour, added, "The submission of a request for a Pre-IND meeting with the FDA underscores our commitment to addressing the critical need for a diabetes cure with an off-the shelf human allogenic stem cell-derived pancreatic islet product together with iTolerance's proprietary immunomodulator, iTOL-100, that may reduce or obviate the need for life-long immunosuppression following transplantation. By working closely with Kadimastem, we believe we can unlock the potential for cell therapies for the treatment, and potential cure of Type 1 diabetes."Alexander Zwyer, Chief Executive Officer of NLS Pharmaceutics, commented, "We are confident that our pending merger with Kadimastem, once completed, will add significant value to the combined company's pipeline, bringing valuable assets and a promising growth trajectory. We are working toward the merger closing by the end of January and remain optimistic about the positive impact it will have on our future."As previously reported, NLS Pharmaceuticals and Kadimastem entered into an agreement and plan of merger in November 2024. The merger is subject to closing conditions, including the approval of the shareholders of each of the NLS Pharmaceutics and Kadimastem.About NLS Pharmaceutics Ltd.NLS Pharmaceutics is a global development-stage biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists. NLS is focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders. Headquartered in Switzerland and founded in 2015, NLS is led by an experienced management team with a track record of developing and commercializing product candidates. For more information, please visit www.nlspharma.com, the content of which is not part of this press release.About KadimastemKadimastem is a clinical stage cell therapy company, developing "off-the-shelf", allogeneic, proprietary cell products based on its technology platform for the expansion and differentiation of Human Embryonic Stem Cells (hESCs) into functional cells. AstroRx®, the company's lead product, is an astrocyte cell therapy in clinical development for the treatment for ALS and in pre-clinical studies for other neurodegenerative indications.IsletRx is the company's treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon, intended to treat and potentially cure patients with insulin-dependent diabetes. Kadimastem was founded by Professor Michel Revel, Chief Scientific Officer of Kadimastem and Professor Emeritus of Molecular Genetics at the Weizmann Institute of Science. Professor Revel received the Israel Prize for the invention and development of Rebif®, a multiple sclerosis blockbuster drug sold worldwide. Kadimastem is traded on the Tel Aviv Stock Exchange (TASE: KDST).About iTolerance, Inc.iTolerance is an early-stage privately-held regenerative medicine company developing technologies to enable tissue, organoid or cell therapy without requiring life-long immunosuppression. Leveraging its proprietary biotechnology-derived Streptavidin-FasL fusion protein/biotin-PEG microgel (SA-FasL microgel) platform technology, iTOL-100, iTolerance is advancing a pipeline of programs using both allogenic pancreatic islets and stem cells that have the potential to cure diseases. Utilizing iTOL-100 to induce local immune tolerance, iTolerance is developing its lead indication as a potential cure for Type 1 Diabetes without the need for life-long immunosuppression. Additionally, iTolerance is developing iTOL-201 for treating liver failure by utilizing hepatocytes and iTOL-401 as a nanoparticle formulation for large organ transplants without the need for life-long immunosuppression. For more information, please visit itolerance.com, the content of which is not a part of this press release.Safe Harbor StatementThis press release contains expressed or implied forward-looking statements pursuant to U.S. Federal securities laws. For example, NLS and Kadimastem are using forward-looking statements when they discuss the submission of a request for a Pre-IND meeting with the FDA, the positive impact and expected timing of the closing of the merger between NLS Pharmaceutics and Kadimastem and the potential benefits of the transaction to NLS and Kadimastem and their respective shareholders and the potential benefits of the iTOL-102 product, including its safety and efficacy . These forward-looking statements and their implications are based on the current expectations of the management of NLS and Kadimastem, 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: risks related to the companies' ability to have a successful meeting with the FDA, complete the merger on the proposed terms, including risks and uncertainties related to the satisfaction of the closing conditions related to the merger agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approvals for the transaction; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed merger; changes in technology and market requirements; either or both companies may encounter delays or obstacles in launching and/or successfully completing their clinical trials; the companies' products may not be approved by regulatory agencies; their technologies may not be validated as they progress and their methods may not be accepted by the scientific community; either of both of the companies may be unable to retain or attract key employees whose knowledge is essential to the development of their products; unforeseen scientific difficulties may develop with the products being advanced by the companies; their products may wind up being more expensive than anticipated; 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; the companies' patents may not be sufficient; their products may harm recipients; changes in legislation may adversely impact either or both of the companies; inability to timely develop and introduce new technologies, products and applications; and loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of candidate products to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, neither Kadimastem nor NLS undertakes any 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, 2023, 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.No Offer or SolicitationThis communication is not intended to and shall not constitute an offer to buy or sell or the solicitation of an offer to buy or sell any securities, or a solicitation of any vote or approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made, except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.Additional Information about the Transaction and Where to Find ItIn connection with the proposed merger between NLS Pharmaceutics and Kadimastem, NLS Pharmaceutics intends to file a registration statement on Form F-4, including a proxy statement/prospectus, with the SEC. NLS Pharmaceutics may also file other relevant documents with the SEC regarding the proposed merger. This document is not a substitute for the proxy statement/prospectus or any other document that NLS Pharmaceutics may file with the SEC. The proxy statement (if and when available) will be mailed to shareholders of NLS. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER. Investors and security holders will be able to obtain free copies of the proxy statement/prospectus (if and when available) and other documents containing important information about NLS and Kadimastem and the proposed merger, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by the Company will be available free of charge on NLS's website at www.nlspharma.com.Participants in the SolicitationNLS Pharmaceutics, Kadimastem, and certain of their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NLS Pharmaceutics and Kadimastem shareholders in respect of the proposed transaction. Information about the directors and executive officers of NLS Pharmaceutics, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in NLS Pharmaceutics'' Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on May 15, 2024. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed merger when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from NLS Pharmaceutics using the sources indicated above.Social Media: LinkedIn, Twitter, Facebook, InstagramNLS Pharmaceutics Contacts:[email protected]www.nlspharma.comKadimastem Contacts:Sara Bazak, Investors relationship[email protected]www.kadimastem.comiTolerance Contacts:Jenene ThomasJTC Team, LLC[email protected][email protected]https://itolerance.com/SOURCE: NLS Pharmaceutics AGRelated Documents:

Cell TherapyImmunotherapyAcquisition

12 Sep 2024

·www.businesswire.com

Merck Unveils New MAVENCLAD® Four-Year Data Highlighting Benefits of Early Treatment and Sustained Efficacy Across Multiple Measures of Disease Activity

DARMSTADT, Germany--( BUSINESS WIRE )-- Not intended for UK-, US- or Canada-based media Merck, a leading science and technology company, today announced presentations showcasing the long-term safety profile, sustained efficacy data, and durable effect of MAVENCLAD ® (cladribine tablets) in individuals with relapsing multiple sclerosis (RMS). Among 34 total MAVENCLAD presentations are data from several MAGNIFY-MS sub-studies demonstrating the impact of MAVENCLAD on disability progression, central inflammation, and an oral presentation on immune reconstitution effects. These data, along with six other company abstracts, will be presented at the 40 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) taking place September 18-20 in Copenhagen. “The efficacy of MAVENCLAD has long been established through traditional endpoints from our original pivotal trials and beyond. Now, with additional measures of the impact on neuroinflammation and progression, we can reaffirm and further solidify its long-term efficacy position within the MS treatment landscape,” said Alexander Kulla, Senior Vice President & Medical Unit Head Neurology & Immunology at Merck. “MAVENCLAD continues to demonstrate its consistent safety profile with sustained benefits, impacting the lives of more than 100,000 people living with MS." Results from the MAGNIFY-MS extension, a Phase IV study evaluating patients (n=219) on MAVENCLAD with highly active RMS, confirmed 79.2% of patients achieved no evidence of disease activity (NEDA-3) during Year 4 of the treatment. The annualized relapse rate (ARR) remained low overall (0.09) and was further reduced (0.06) in treatment-naïve patients over four years. Similarly, the CLARIFY-MS extension showed the sustained benefits in MAVENCLAD-treated patients (n=280) on cognition, in addition to MRI outcomes and relapses, four years after the initial treatment dose. Specific to cognition, 77.5% of patients had improved or stable scores at four years, based on the 8-point cut-off of the Symbol Digit Modalities Test (SDMT). In both studies, safety data aligned with the established profile from clinical trials. Two-year data from a MAGNIFY-MS sub-study found patients with highly active RMS treated with MAVENCLAD had low overall disability accrual, including low rates of progression independent of relapse activity (PIRA). At two years, rates for all disability measures were low overall with 93.7% of patients free from PIRA. The reduction of PIRA is especially notable in treatment-naïve patients (3.4% vs 8.5% in treatment-experienced patients), emphasizing the benefits of early treatment initiation with MAVENCLAD. Overall, these data suggest that MAVENCLAD is likely to preserve the physical abilities and prevent relapses in individuals with RMS, supporting the sustained efficacy and durable effect of MAVENCLAD. Building on prior data, which showed MAVENCLAD reduces or eliminates oligoclonal bands in the cerebrospinal fluid (CSF), new two-year data demonstrate reductions in gene expression and protein levels of markers associated with inflammation, including pro-inflammatory cytokines, providing insights into the potential multifaceted effect of MAVENCLAD in the peripheral blood and CSF. This data suggests that immune reconstitution following treatment with cladribine tablets may shift the immune system to a less pathogenic state. Analyses of CSF proteomics and T and B cell transcriptomics further substantiate the clinical findings, suggesting the potential of MAVENCLAD to reduce disease activity and progression in RMS patients. To view our 40 accepted abstracts and posters to be presented from across our MS portfolio at ECTRIMS, including innovative analyses of MAVENCLAD using artificial intelligence, please visit the Programme . About MAVENCLAD ® MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29, 2019, is the first and only short-course oral therapy for the treatment of adults with relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS). Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis (MS), and MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS). Patients should follow healthcare provider instructions including cancer screening, contraception and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose-dependent reduction in lymphocyte counts followed by recovery. Because cladribine is cytotoxic, special handling and disposal instructions should be followed. More than 100,000 patients have been treated with MAVENCLAD since its launch in 2019. MAVENCLAD has been approved in over 80 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications. Visit www.MAVENCLAD.com for more information. About Multiple Sclerosis Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common. Merck in Neurology and Immunology Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company’s current MS portfolio includes two products for the treatment of relapsing MS – Rebif ® (interferon beta-1a) and MAVENCLAD ® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck’s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE), cutaneous lupus erythematosus (CLE) and generalized myasthenia gravis (gMG). About Merck Merck, a leading science and technology company, operates across life science, healthcare and electronics. Around 63,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2023, Merck generated sales of €21 billion in 65 countries. Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as MilliporeSigma in life science, EMD Serono in healthcare, and EMD Electronics in electronics. All Merck press releases are distributed by e-mail at the same time they become available on the Merck website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

Clinical ResultDrug ApprovalPhase 2

100 Deals associated with INTERFERON BETA-1A(Merck Serono SA)

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KEGG	Wiki	ATC	Drug Bank
D04554	INTERFERON BETA-1A(Merck Serono SA)	L03AB07	DB00060

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis	European Union	Merck Europe BV	03 May 1998
Multiple Sclerosis	Iceland	Merck Europe BV	03 May 1998
Multiple Sclerosis	Liechtenstein	Merck Europe BV	03 May 1998
Multiple Sclerosis	Norway	Merck Europe BV	03 May 1998

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	Phase 3	-	Merck KGaA	01 Dec 2006
Clinically isolated syndrome	Phase 3	Canada	Merck KGaA	01 Oct 2005
Multiple sclerosis relapse	Phase 3	United States	EMD Serono, Inc.	01 Jan 2005
Colitis, Ulcerative	Phase 2	Germany	EMD Serono, Inc.	01 Dec 2001
Colitis, Ulcerative	Phase 2	Germany	Merck Serono International SA	01 Dec 2001
Colitis, Ulcerative	Phase 2	Israel	EMD Serono, Inc.	01 Dec 2001
Colitis, Ulcerative	Phase 2	Israel	Merck Serono International SA	01 Dec 2001
Colitis, Ulcerative	Phase 2	Netherlands	EMD Serono, Inc.	01 Dec 2001
Colitis, Ulcerative	Phase 2	Netherlands	Merck Serono International SA	01 Dec 2001
Colitis, Ulcerative	Phase 2	Singapore	Merck Serono International SA	01 Dec 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04860518 (HIBISCUS, CTgov)	Phase 2	COVID-19	7	IFN beta-1a (IV IFN Beta-1a)	hddtgmjjph(kapwxksgoe) = lnquaaktgg enipdhchre (aprdxdefra, 0) View more	-	14 Oct 2022
				Dexamethasone (IV Dexamethasone)	hddtgmjjph(kapwxksgoe) = qvwutvcglb enipdhchre (aprdxdefra, 0) View more
NCT00404352 (REFLEX, ECTRIMS2022)	Phase 3	Demyelinating Diseases GDF-15	-	sc IFN β-1a tiw	rcbzvtlsjf(xpxslijion) = bxwqlvtvjp noubaghiha (nrjzfhgyzz )	-	12 Oct 2022
				Placebo	rcbzvtlsjf(xpxslijion) = wncrnippfn noubaghiha (nrjzfhgyzz )
NCT00404352 (REFLEX, ECTRIMS2021)	Phase 3	GDF-15	480	sc IFN β-1a 44mcg once weekly	pwdrfbhjcd(qqoolzncvh) = ybmkcjyxsr xasfvqbrhv (fasuhntqrf )	-	12 Oct 2021
				sc IFN β-1a 44mcg three-times weekly	pwdrfbhjcd(qqoolzncvh) = xrklzwuxhc xasfvqbrhv (fasuhntqrf )
EAN2020	Not Applicable	Multiple Sclerosis	-	subcutaneous interferon beta-1a (sc IFNbeta-1a) (18-30 years old)	khkiuymigs(augxgjtqtk) = bnyinzklnc dwsxbzhoxs (jcsixeexnh, 0.16 - 0.34) View more	-	22 May 2020
				subcutaneous interferon beta-1a (sc IFNbeta-1a) (31-40 years old)	sfyoehqggc(lzqtgqmgmf) = yivkarkqcq rkrbdagibp (yhggbmwpcw ) View more
EAN2020	Not Applicable	Multiple Sclerosis	-	Subcutaneous Interferon-beta1a (Rebif 22Âµg and 44Âµg)	zfdlsfguue(kvansgsodm) = psyxyhften zquwbtcztm (naqgpaegzg )	-	22 May 2020
				Intramuscular Interferon-beta1a (Avonex)	zfdlsfguue(kvansgsodm) = wonyxwkmun zquwbtcztm (naqgpaegzg )
NCT03387046 (INCREASE, CTgov)	Phase 2	Multiple Sclerosis, Relapsing-Remitting	7	D-aspartate+IFN beta-1a+Methylprednisolone (D-aspartate + IFN Beta-1a + Methylprednisolone)	dkmclszydg = ugnmpjhoxb zpsmvpggir (qodjmubsxu, evokdyovtn - hmueomjxwv) View more	-	10 Feb 2020
				Placebo+IFN beta-1a+Methylprednisolone (Placebo + IFN Beta-1a + Methylprednisolone)	dkmclszydg = pqwyixzuou zpsmvpggir (qodjmubsxu, proetotyfk - wfjmbhongo) View more
NCT01285401 (SOLAR, Pubmed) Manual	Phase 2	Multiple Sclerosis, Relapsing-Remitting	229	Colecalciferol+Interferon Beta-1a	ahneasduvj(zsieydhwui) = aenwcpywmv zrpmbjohhq (yhklqswyie )	Negative	12 Nov 2019
				Placebo+Interferon Beta-1a	ahneasduvj(zsieydhwui) = wspkxjirej zrpmbjohhq (yhklqswyie )
NCT01791244 (RebiQoL, Pubmed \| PLoS One)	Phase 4	Multiple Sclerosis	93	Rebif (MSP)	zagbdpslgi(okvrizfzqw): OR = 3.5 (95% CI, 0.85 - 14.4), P-Value = 0.08	Negative	05 Jul 2019
				Rebif (Technical support only)
NCT00441103 (IMPROVE study, ECTRIMS2018)	Phase 3	Multiple Sclerosis, Relapsing-Remitting	-	IFN beta-1a 44 mcg	qplvmxpnxa(kdndmalxlq) = ayslawyfsg erhhahjmcy (ecwjcwpdfj )	-	09 Oct 2018
				Placebo	qplvmxpnxa(kdndmalxlq) = dnwboxduqv erhhahjmcy (ecwjcwpdfj )
NCT02064816 (RELIEF, CTgov)	Phase 4	Influenza-like symptoms \| Multiple Sclerosis, Relapsing-Remitting \| Multiple sclerosis relapse	200	Rebif (Rebif Morning Administration)	ijvfzebjbg(mwhogcwksc) = hjtngdeyuv dzdntbbnhs (hlvlgissbq, 3.87) View more	-	20 Sep 2018
				Rebif (Rebif Evening Administration)	ijvfzebjbg(mwhogcwksc) = dviycblzlh dzdntbbnhs (hlvlgissbq, 3.02) View more

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