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  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Review, Journal:  GSK-3: An "Ace" Among Kinases. (Pubmed Central) -  Nov 13, 2024   
    Significant findings of miRNA regulation by GSK-3 exemplify the underpinnings of kinase-mediated transcriptional regulation in cancers. The review provides evidence on the role of GSK-3 as a possible master regulator of proteins and noncoding RNA, thereby implicating the fate of a cell.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Journal:  The Effect of Tideglusib Application on Type 1 and Type 3 Collagen Expressions by Human Dental-Pulp Derived Stem Cells: A Preliminary Study. (Pubmed Central) -  Sep 30, 2024   
    inhibition in patients with arrhythmogenic cardiomyopathy, this report aims to review the advantages and disadvantages of this strategy. The fact that Wnt signaling pathway activation obtained by Tideglusib application on DPSCs confirmed by the finding in the increase of Axin-2 at short and long-term evaluation periods which is resulted in the increase in the type 1 collagen expression at 24 h and decrease at 1 week together with the decrease in type 3 collagen expression at 1 week warrants further studies to evaluate the effect of Tideglusib on extracellular matrix expression.
  • ||||||||||  Nypta (tideglusib) / ASD Therap, Amnolake (tamibarotene) / Syros
    Journal:  Cocktail Cell-Reprogrammed Hydrogel Microspheres Achieving Scarless Hair Follicle Regeneration. (Pubmed Central) -  Jan 16, 2024   
    In vitro and in vivo studies show that AHFS can regulate fibroblast fate, induce fibroblast-to-DPC reprogramming by activating the PI3K/AKT pathway, finally promoting wound healing and in situ HF regeneration while inhibiting scar formation in a two-pronged translational approach. In conclusion, AHFS provides a new and effective strategy for functional repair of skin wounds.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Journal:  Tideglusib-incorporated nanofibrous scaffolds potently induce odontogenic differentiation. (Pubmed Central) -  Aug 8, 2023   
    In contrast to current pulp capping material driving dentin repair, the sophisticated, polymeric scaffold systems with soluble and insoluble spatiotemporal cues described here can direct stem cell differentiation and dentin regeneration. Hence, bioactive small molecule-incorporated nanofibrous scaffold suggests an innovative clinical tool for dentin tissue engineering.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Journal:  Therapeutic Targeting of the GSK3?-CUGBP1 Pathway in Myotonic Dystrophy. (Pubmed Central) -  Jul 18, 2023   
    We have previously described the benefits of the correction of the GSK3?-CUGBP1 pathway in DM1 mice (HSA model) expressing 250 CUG repeats using the GSK3 inhibitor tideglusib (TG)...Using a mouse model with dysregulated CUGBP1, which mimics alterations in DM1, we showed that the dysregulated CUGBP1 contributes to the toxicity of expanded CUG repeats by changing gene expression and causing CNS abnormalities. These data show the critical role of the GSK3?-CUGBP1 pathway in DM1 muscle and in CNS pathologies, suggesting the benefits of GSK3 inhibitors in patients with different forms of DM1.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Trial completion date, Trial primary completion date:  TIDALS: Tideglusib for the Treatment of Amyotrophic Lateral Sclerosis (clinicaltrials.gov) -  Jun 2, 2023   
    P2,  N=98, Not yet recruiting, 
    degraders as potential therapeutic agents. Trial completion date: Mar 2024 --> Mar 2026 | Trial primary completion date: Dec 2023 --> Dec 2025
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Enrollment status, Enrollment change, Trial completion date, Trial primary completion date:  REACH CDM X: Safety and Efficacy of Tideglusib in Congenital or Childhood Onset Myotonic Dystrophy (clinicaltrials.gov) -  May 24, 2023   
    P2/3,  N=76, Recruiting, 
    Trial completion date: Mar 2024 --> Mar 2026 | Trial primary completion date: Dec 2023 --> Dec 2025 Enrolling by invitation --> Recruiting | N=56 --> 76 | Trial completion date: Mar 2023 --> Mar 2025 | Trial primary completion date: Mar 2023 --> Mar 2025
  • ||||||||||  Review, Journal:  The myotonic dystrophy type 1 drug development pipeline: 2022 edition. (Pubmed Central) -  Mar 2, 2023   
    Three interventional first-in-human clinical trials got underway with distinct drug classes, namely AOC 1001 and DYNE-101 nucleic acid-based therapies, and the small molecule pitolisant, which joins the race toward market authorization with other repurposed drugs, including tideglusib, metformin, or mexiletine, already in clinical evaluation. Furthermore, newly disclosed promising preclinical data for several additional nucleic-acid therapeutic candidates and a CRISPR-based approach, as well as the advent into the pipeline of novel therapeutic programs, increase the plausibility of success in the demanding task of providing valid treatments to patients with DM1.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Enrollment closed, Trial primary completion date:  REACH CDM: Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy (clinicaltrials.gov) -  Feb 24, 2023   
    P2/3,  N=56, Active, not recruiting, 
    Furthermore, newly disclosed promising preclinical data for several additional nucleic-acid therapeutic candidates and a CRISPR-based approach, as well as the advent into the pipeline of novel therapeutic programs, increase the plausibility of success in the demanding task of providing valid treatments to patients with DM1. Recruiting --> Active, not recruiting | Trial primary completion date: Jan 2023 --> Apr 2023
  • ||||||||||  Nypta (tideglusib) / ASD Therap, LY2090314 / Eli Lilly
    Journal:  Molecular docking study of GSK-3β interaction with nomilin, kihadanin B, and related limonoids and triterpenes with a furyl-δ-lactone core. (Pubmed Central) -  Sep 20, 2022   
    Numerous inhibitors of GSK-3β have been discovered but thus far only a few have reached clinical trials and only one drug, tideglusib (1), has been registered...The formation of GSK-3β-binding complexes for those natural products was compared to reference GSK-3β ATP-competitive inhibitors LY2090314 (3) and AR-A014418 (2)...Compound structure-binding relationships are discussed. The study should help the discovery of novel natural products targeting GSK-3β.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Journal:  Tideglusib Inhibits Pif1 Helicase of Bacteroides sp. via an Irreversible and Cys-380-Dependent Mechanism. (Pubmed Central) -  Sep 14, 2022   
    Furthermore, inhibition of BaPif1 by TD was significantly attenuated in the presence of dithiothreitol, indicating that TD could be a thiol-reactive compound. We also identified that Cys-380 of BaPif1 is critical for the inhibition by TD, suggesting that TD inhibits BaPif1 via an irreversible and Cys-380-dependent mechanism.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    TREAT-NMD myotonic dystrophy Global Registry Network: Providing data in congenital myotonic dystrophy to support FDA regulatory decision making (Poster area - Ballroom B1-B2) -  Aug 20, 2022 - Abstract #WMS2022WMS_447;    
    AMO Pharma used the data to successfully support their application for a RPD Designation from the FDA for tideglusib...Registries can be used in all stages of drug development, including providing data to support regulatory applications where data are scarce. cDM1 is an important subset of DM1 with its own research needs and opportunities; DM1 registries need to collect specific data relevant to these patients to support such activities.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Journal:  Tideglusib promotes wound healing in aged skin by activating PI3K/Akt pathway. (Pubmed Central) -  Jun 23, 2022   
    The decreased expression of EGFR in epidermis with age resulted in decreased activity of the PI3K/Akt pathway and limited EGF efficacy. Tideglusib could assist wound healing in aged rats via activating PI3K/Akt pathway, which may be considered as an ingredient for medical and cosmetics use.
  • ||||||||||  Nypta (tideglusib) / ASD Therap, benzesulfonate (PF-562271) / Pfizer
    Journal:  Focal adhesion kinase inhibitors prevent osteoblast mineralization in part due to suppression of Akt-mediated stabilization of osterix. (Pubmed Central) -  May 29, 2022   
    In this study we evaluated whether use of the FAK TKI PF-562,271 affected the differentiation of pre-osteoblasts, or activity of mature differentiated osteoblasts...As we observed that FAK TKI also resulted in suppression of Akt, which is known to alter osterix protein stability downstream of RUNX2, we examined protein levels by western blot and found a dose-dependent decrease in osterix in FAK TKI treated differentiated MC3T3-E1 cells which is likely responsible for the reduced mineralization observed. Taken together our results suggest that use of FAK TKIs as therapeutics in the bone metastatic setting may block new bone formation as an off-target effect and thereby exacerbate the defective bone regulation that is characteristic of the bone metastatic environment.
  • ||||||||||  Nypta (tideglusib) / ASD Therap
    Trial completion date, Trial primary completion date:  REACH CDM: Efficacy and Safety of Tideglusib in Congenital Myotonic Dystrophy (clinicaltrials.gov) -  May 17, 2022   
    P2/3,  N=56, Recruiting, 
    Graphical abstract. Trial completion date: Mar 2022 --> Feb 2023 | Trial primary completion date: Mar 2022 --> Jan 2023
  • ||||||||||  diazepinomicin (AMO-01) / AMO Pharma
    Preclinical, Journal:  Secondary Metabolites of Actinomycetales as Potent Quorum Sensing Inhibitors Targeting Gram-Positive Pathogens: In Vitro and In Silico Study. (Pubmed Central) -  Mar 25, 2022   
    The results indicated that four compounds, Phenalinolactones A-D, BU-4664LMe, 4,5-dehydrogeldamycin, and Questinomycin A, potentially inhibit the agr quorum sensing system and hemolytic activity of S. aureus...Further, in silico molecular docking studies were performed which provided closer insights into the mode of action of these compounds and proposed that the inhibitory activity of these compounds could be attributed to their potential ability to bind to the ATP-active site of S. aureus AgrA. Taken together, our study highlights the potential of actinomycetales secondary metabolites with diverse structures as anti-virulence quorum sensing inhibitors.
  • ||||||||||  Nypta (tideglusib) / ASD Therap, LY2090314 / Eli Lilly, elraglusib (9-ING-41) / Actuate Therap
    Journal:  Proposed hypothesis of GSK-3 β inhibition for stimulating Wnt/β-catenin signaling pathway which triggers liver regeneration process. (Pubmed Central) -  Mar 11, 2022   
    Various signaling pathways for liver regeneration are HO-1/BER pathway, Tweak/Fn14 signaling pathway, Hippo pathway, Wnt/beta-catenin pathway, Hedgehog signaling pathway, bile acids repairing pathway, serotonin (5HT) pathway, estrogen pathway, thyrotropin-releasing hormone (TRH) pathway, insulin repairing pathway, etc. The in vitro scientific literature revealed that numerous GSK-3 β inhibitors (LY 2090314, AR-A014418, Tideglusib, Solasodine, CHIR99021, 9-ING-41, SB-216763) play an important role in stimulating the liver regeneration process. Similarly, from the above discussion, the direction is highlighted to emphasize the proposed molecular Wnt/β-catenin signaling pathway which is associated with GSK-3 β inhibition for the induction of the repairing and regeneration process.