lanabecestat (AZD3293) / AstraZeneca, Eli Lilly 
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  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly, amatuximab (MORAb-009) / Eisai
    Journal, CAR T-Cell Therapy:  Mesothelin antigen density influences anti-mesothelin chimeric antigen receptor T cell cytotoxicity. (Pubmed Central) -  Apr 8, 2024   
    These data highlight the value of assessing CAR constructs against a panel of cells expressing varying degrees of target tumor antigen as occurs in human tumors. Furthermore, the problem of low antigen density may be overcome by concomitant administration of drugs that inhibit enzymatic shedding of MSLN.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Journal:  Genetic and chemical disruption of amyloid precursor protein processing impairs zebrafish sleep maintenance. (Pubmed Central) -  Feb 6, 2024   
    Treatment with the ?-secretase inhibitor DAPT also shortened night sleep bouts, whereas the BACE-1 inhibitor lanabecestat lengthened sleep bouts. Intraventricular injection of P3 also shortened night sleep bouts, suggesting that the proper balance of Appb proteolytic processing is required for normal sleep maintenance in zebrafish.
  • ||||||||||  verubecestat (MK-8931) / Merck (MSD), lanabecestat (AZD3293) / AstraZeneca, Eli Lilly, elenbecestat (E2609) / Eisai, Biogen
    Journal:  BACE-1 Inhibitors Targeting Alzheimer's Disease. (Pubmed Central) -  Jun 13, 2023   
    The current status of developing new peptidomimetic, non-peptidomimetic, naturally occurring, and other class inhibitors are demonstrated, considering their main limitations and lessons learned. The goal is to provide a broad and complete approach to the subject, exploring new chemical classes and perspectives.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    BACE1 DELETION IN THE ADULT REVERSES EPILEPTIFORM ACTIVITY AND SLEEP-WAKE DISTURBANCES IN AD MICE MODELS (EXHIBITION) -  Dec 23, 2022 - Abstract #ADPD2023ADPD_1367;    
    Meth ods: We performed video -EEG/EMG recordings in 12 -hour light/12 -hour dark cycle in nine -month -old 5xFAD and APP KI (APP NL-G-F/NL -G-F) mice treated with or without BACE1 inhibitor AZD3293 as well as adult BACE1fl/fl/thyCre, BACE1fl/fl/aldh1l1CreERT2, and BA CE1fl/fl/ubcCreERT2 mice... Our study provides insight into functional impairments of epileptiform activity and sleep disruption in two AD mouse models, BACE1 deletion and inhibition rescues deficits in 5xFAD mice but not APP KI mice.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly, donanemab (LY3002813) / Eli Lilly, solanezumab (LY2062430) / Eli Lilly
    Combination of regional flortaucipir quantification and event-based modeling in clinical trial analyses (Grand Ballroom AB - Tower 2) -  Oct 5, 2022 - Abstract #CTAD2022CTAD_250;    
    P2, P2/3,
    The EBM approach may better illustrate the therapeutic effect of AD treatment on tau PET by providing evidence of tau spread (Schwarz, Neurotherapeutics, 2021) to complement global tau measures. Larger trial data can further confirm these observations.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Unbiased phenotypic screening of diverse sets of compounds through cell painting. | Poster Board #3374 (Hall F2 (McCormick Place Convention Center)) -  Aug 9, 2022 - Abstract #ACSFall2022ACS_Fall_3327;    
    Indeed, XK00001387 is structurally similar to lanabecestat, an oral beta-secretase inhibitor under clinical development.We developed a new method (“Aza-Yang cyclization”) for the synthesis of azetidinol ring through photochemistry...We will compare the differences and similarities of the generated fingerprints against a standard set of compounds with a known mechanism of action. Results of the cell painting experiment will be introduced.
  • ||||||||||  verubecestat (MK-8931) / Merck (MSD), lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Journal:  BACE1 controls synaptic function through modulating release of synaptic vesicles. (Pubmed Central) -  Mar 15, 2022   
    Similarly, mice treated with mGluR1 PAM showed significantly mitigated synaptic deficits caused by BACE1 inhibitors. Together, our data suggest that a therapy combining BACE1 inhibitors for reducing amyloid deposition and an mGluR1 PAM for counteracting BACE1-mediated synaptic deficits appears to be an effective approach for treating AD patients.
  • ||||||||||  DEVELOPING BETA-SECRETASE INHIBITORS FOR TREATMENT OF ALZHEIMER’S DISEASE () -  Mar 9, 2022 - Abstract #ADPD2022ADPD_1122;    
    The capability of BACE1 to apply such a therapeutic candidate for AD therapy has just been examined during the previous decade. There is proof indicate that the 1 inhibitor administrating time is critical and make big difference in how successful they are in curing AD.
  • ||||||||||  verubecestat (MK-8931) / Merck (MSD), lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Journal:  Cognitive outcomes in trials of two BACE inhibitors in Alzheimer's disease. (Pubmed Central) -  Sep 29, 2021   
    There is proof indicate that the 1 inhibitor administrating time is critical and make big difference in how successful they are in curing AD. In both studies, many measures showed treatment-associated cognitive worsening, whereas verbal fluency tasks showed improvement.
  • ||||||||||  Review, Journal:  Selective Secretase Targeting for Alzheimer's Disease Therapy. (Pubmed Central) -  Sep 17, 2021   
    Such therapeutic tools shall focus on slowing down or minimizing the progression of neuronal damage. Here, we summarize structures and the activities of the latest compounds designed for AD treatment, with remarkable in vitro, in vivo, and clinical phase activities.
  • ||||||||||  verubecestat (MK-8931) / Merck (MSD), neflamapimod (VX-745) / EIP Pharma, lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Clinical Results with Novel Approaches that Reverse BFCN Dysfunction (Ballroom) -  Aug 7, 2021 - Abstract #CTAD2021CTAD_12;    
    In the case of BACE inhibition, clinical evidence supporting the approach to target BFCN dysfunction was provided in a combined retrospective analysis of phase 3 clinical trials conducted with verubecestat and lanabecestat, respectively, in which the effects of these BACE inhibitors on specific cognitive domains were evaluated...In the case of p38α inhibition, results of a phase 2, 91-patient, 16-week, placebo-controlled study (“AscenD-LB”) with the specific p38α kinase inhibitor neflamapimod (at 40mg TID) demonstrated statistically significant, clinically relevant effect size (0.5) improvement relative to placebo in a cognitive test battery assessing attention and executive function...Finally, dose-dependent improvement relative to placebo was seen in hallucination severity and frequency, another outcome considered related to cholinergic dysfunction. The results of the AscenD-LB study, the totality of which indicates a substantial positive effect on BFCN function, are to be confirmed in a 160-patient phase 2b study that is planned to commence in the fourth quarter of 2021.
  • ||||||||||  Review, Journal:  BACE1 inhibitors: Current status and future directions in treating Alzheimer's disease. (Pubmed Central) -  Jul 9, 2021   
    Furthermore, the review demonstrates with increasing evidence that despite tremendous efforts and promising results conceived with BACE1 inhibitors, the latest studies suggest that their clinical use for treating Alzheimer's disease should be reconsidered. Finally, the review sheds light on alternative therapeutic options for targeting AD.
  • ||||||||||  LY2886721 / Eli Lilly, lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Journal:  Partial reduction of amyloid β production by β-secretase inhibitors does not decrease synaptic transmission. (Pubmed Central) -  Jun 26, 2021   
    Our results indicate that Aβ production can be reduced by up to 50%, a level of reduction of relevance to the protective effect of the Icelandic mutation, without causing synaptic dysfunction. We therefore suggest that future clinical trials aimed at prevention of Aβ build-up in the brain should aim for a moderate CNS exposure of BACE inhibitors to avoid side effects on synaptic function.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Journal:  Assessment of Transporter Polymorphisms as a Factor in a BCRP Drug Interaction Study With Lanabecestat. (Pubmed Central) -  Feb 4, 2021   
    Lanabecestat + rosuvastatin was associated with few treatment-emergent adverse events, all of which resolved and were mild. Lanabecestat does not meaningfully impact BCRP activity; therefore, restriction of concomitant administration with BCRP substrates, such as rosuvastatin, may be unnecessary.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    [VIRTUAL] Reasons for Study Exclusion by Sex in Lanabecestat Studies AMARANTH and DAYBREAK-ALZ () -  Aug 2, 2020 - Abstract #AAIC2020AAIC_3380;    
    P2/3, P3
    These results suggest females presenting for screening may have more advanced disease. Possible reasons include late referral of females due to advanced verbal memory skills delaying recognition of disease, social circumstances, faster disease progression of females identified from clinical trial site databases, or differences in educational attainment.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Enrollment change, Trial termination:  DAYBREAK-ALZ: A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) -  Oct 26, 2018   
    P3,  N=5697, Terminated, 
    N=2202 --> 7255 N=1899 --> 5697 | Recruiting --> Terminated; An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Enrollment change, Trial termination:  A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia (clinicaltrials.gov) -  Oct 26, 2018   
    P3,  N=422, Terminated, 
    N=1899 --> 5697 | Recruiting --> Terminated; An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility. N=1400 --> 422 | Recruiting --> Terminated; As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Biomarker, Trial termination:  AMARANTH: An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (clinicaltrials.gov) -  Oct 23, 2018   
    P2/3,  N=2202, Terminated, 
    N=1400 --> 422 | Recruiting --> Terminated; As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped. Active, not recruiting --> Terminated; An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Biomarker, Enrollment open:  AMARANTH: An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (clinicaltrials.gov) -  Sep 21, 2018   
    P2/3,  N=2202, Recruiting, 
    Active, not recruiting --> Terminated; An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility Active, not recruiting --> Recruiting
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Biomarker, Trial completion date, Trial primary completion date:  AMARANTH: An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (clinicaltrials.gov) -  Jul 9, 2018   
    P2/3,  N=2202, Active, not recruiting, 
    Active, not recruiting --> Recruiting Trial completion date: Sep 2019 --> Oct 2018 | Trial primary completion date: Sep 2019 --> Oct 2018
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Trial completion date, Trial primary completion date:  A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia (clinicaltrials.gov) -  Jul 9, 2018   
    P3,  N=1400, Active, not recruiting, 
    Trial completion date: Sep 2019 --> Oct 2018 | Trial primary completion date: Sep 2019 --> Oct 2018 Trial completion date: Sep 2021 --> Oct 2018 | Trial primary completion date: Sep 2021 --> Oct 2018
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Trial completion date, Trial primary completion date:  DAYBREAK-ALZ: A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia (clinicaltrials.gov) -  Jul 9, 2018   
    P3,  N=1899, Active, not recruiting, 
    Trial completion date: Sep 2021 --> Oct 2018 | Trial primary completion date: Sep 2021 --> Oct 2018 Trial completion date: Jul 2021 --> Oct 2018 | Trial primary completion date: Jan 2020 --> Oct 2018
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Enrollment change, Trial withdrawal:  A Study of Lanabecestat in Healthy Female Participants Taking Oral Contraceptive (clinicaltrials.gov) -  Jun 28, 2018   
    P1,  N=0, Withdrawn, 
    Trial completion date: Jul 2021 --> Oct 2018 | Trial primary completion date: Jan 2020 --> Oct 2018 N=28 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Enrollment change, Trial withdrawal:  A Study of LY3314814 in Participants With Liver Impairment (clinicaltrials.gov) -  Jun 28, 2018   
    P1,  N=0, Withdrawn, 
    N=28 --> 0 | Not yet recruiting --> Withdrawn N=48 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  lanabecestat (AZD3293) / AstraZeneca, Eli Lilly
    Enrollment closed:  A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia (clinicaltrials.gov) -  Jun 27, 2018   
    P3,  N=1400, Active, not recruiting, 
    N=20 --> 0 | Not yet recruiting --> Withdrawn Enrolling by invitation --> Active, not recruiting