Triolex (bezisterim) / BioVie 
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 23 Diseases   3 Trials   3 Trials   82 News 
  • ||||||||||  Triolex (bezisterim) / BioVie
    Review, Journal:  New insights in lipid metabolism: potential therapeutic targets for the treatment of Alzheimer's disease. (Pubmed Central) -  Sep 26, 2024   
    The implications of these findings suggest that targeting lipid metabolism could offer new avenues for the treatment and management of AD. By concentrating on alterations in lipid metabolism within the central nervous system and their contribution to AD development, this review aims to shed light on novel research directions and treatment approaches for combating AD, offering hope for the development of more effective management strategies.
  • ||||||||||  Triolex (bezisterim) / BioVie
    P2 data, Journal:  A phase 2, open-label study of anti-inflammatory NE3107 in patients with dementias. (Pubmed Central) -  Jul 30, 2024   
    Our results indicate that in this study NE3107 was associated with what appear to be positive neurophysiological and neuropsychological findings, as well as evidence of improvement in biomarkers associated with neuroinflammation and AD in patients diagnosed with dementia. Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis.
  • ||||||||||  Triolex (bezisterim) / BioVie
    Enrollment open, Phase classification, Trial completion date, Trial initiation date, Trial primary completion date:  Insulin-sensitizing NE3107 in Improving Sleep and Fatigue in Subjects With Traumatic Brain Injury (clinicaltrials.gov) -  Jul 17, 2024   
    P2,  N=5, Recruiting, 
    Our findings are consistent with previous preclinical and clinical observations and highlight a central role of neuroinflammation in AD pathogenesis. Not yet recruiting --> Recruiting | Phase classification: P2a --> P2 | Trial completion date: Jul 2024 --> Jul 2025 | Initiation date: Aug 2023 --> Dec 2023 | Trial primary completion date: Jun 2024 --> Dec 2024
  • ||||||||||  Triolex (bezisterim) / BioVie
    Journal:  Excess mortality among individuals who have undergone addiction treatment: a study from Greenland. (Pubmed Central) -  Jul 1, 2024   
    Of the 3286 in treatment, 53.9% were women, with a median age of 37...This study found that individuals seeking treatment for addiction problems in Greenland had a higher mortality rate than the general population. Importantly, these SMRs were substantially lower than those observed in clinical populations in other countries.
  • ||||||||||  Triolex (NE3107) / BioVie
    Trial completion, Enrollment change:  A Phase 3 Study of NE3107 in Probable Alzheimer's Disease (clinicaltrials.gov) -  Nov 13, 2023   
    P3,  N=439, Completed, 
    Importantly, these SMRs were substantially lower than those observed in clinical populations in other countries. Active, not recruiting --> Completed | N=316 --> 439
  • ||||||||||  Triolex (NE3107) / BioVie
    Effects of NE3107 anti-inflammatory treatment on motor activity and neurodegenerative features of Parkinson (C1 M3, Ground floor) -  Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_1504;    
    Our results indicate the potential of anti-inflammatory?mediated motor control by NE3107, improved benefit in combination with levodopa, and reduction of LID and TH loss. These observations support the hypothesized role of inflammation in the pathophysiology of motor impairment and LID in PD and the investigation of NE3107 in human clinical trials as a disease-modifying therapy for PD.
  • ||||||||||  Triolex (NE3107) / BioVie
    Treatment-Induced Epigenetic Modifications in MCI and Probable Alzheimer's Disease (In-Person) -  Jul 6, 2023 - Abstract #AAIC2023AAIC_1739;    
    P1/2, P3
    DNAm decreases in monocyte/macrophage are associated with proinflammatory pathways in many disease states but aging epigenetic clocks may select for CpG methylation associated with inhibition of anti-inflammatory pathways. NE3107 decreases in DNAmMonocyte, DNAmSkinBloodAge, DNAmLeptin and DNAmPackYears in MCI and AD subjects were associated with cognitive, biomarker and neuroimaging improvements.
  • ||||||||||  Triolex (NE3107) / BioVie
    Metabolic Dysregulation in Probable Alzheimer (Poster Halls B-C; [Board No. 1520]) -  Apr 10, 2023 - Abstract #ADA2023ADA_875;    
    P3
    and APOE?4 status. Inflammation and insulin resistance may contribute to AD even in the absence of classical risk markers for AD.
  • ||||||||||  Triolex (NE3107) / BioVie
    Enrollment closed:  A Phase 3 Study of NE3107 in Probable Alzheimer's Disease (clinicaltrials.gov) -  Mar 8, 2023   
    P3,  N=316, Active, not recruiting, 
    Conclusions Using safety, tolerability, and efficacy analyses, this study aimed to demonstrate the potential therapeutic benefits of NE3107 in levodopa/carbidopa-treated patients with PD. Recruiting --> Active, not recruiting
  • ||||||||||  Triolex (NE3107) / BioVie
    Trial completion date, Trial primary completion date:  A Phase 3 Study of NE3107 in Probable Alzheimer's Disease (clinicaltrials.gov) -  Jan 26, 2023   
    P3,  N=316, Recruiting, 
    Active, not recruiting --> Completed Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Dec 2022 --> Sep 2023
  • ||||||||||  Leukine (sargramostim) / Partner Therap, Triolex (NE3107) / BioVie
    Preclinical, Journal:  Neuroinflammation, immune response and α-synuclein pathology: how animal models are helping us to connect dots. (Pubmed Central) -  Dec 21, 2022   
    Lastly, this review also considers the current state of the ongoing clinical trials of new drugs designed to target these processes and delay the initiation or progression of the disease. Anti-inflammatory and immunomodulatory agents have been demonstrated to be very promising candidates for reducing disease progression; however, more efforts are needed to reduce the enormous gap between these and dopaminergic drugs, which have dominated the therapeutic market for the last sixty years.
  • ||||||||||  Review, Journal:  Promising candidates from drug clinical trials: Implications for clinical treatment of Alzheimer's disease in China. (Pubmed Central) -  Dec 3, 2022   
    The reuse of drugs or combinations currently under investigation for the psychiatric treatment of Alzheimer's disease, including AXS-05, AVP-786, nabilone, brexpiprazole, methylphenidate, and pimavanserin, could provide physicians with additional treatment options. Although most of these drugs have not been explored in China yet, due to the current development trend in this field in China, it is expected that China will be involved in research on these drugs in the future.
  • ||||||||||  Triolex (NE3107) / BioVie
    Enrollment closed:  NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa (clinicaltrials.gov) -  Oct 19, 2022   
    P1/2,  N=40, Active, not recruiting, 
    Given these reasons, it is now possible to better understand the concerns of people regarding the vaccination process. Recruiting --> Active, not recruiting
  • ||||||||||  Triolex (NE3107) / BioVie
    CLINICAL OUTCOMES FROM A PHASE 2, OPEN-LABEL STUDY OF NE3107 IN PATIENTS WITH COGNITIVE DECLINE DUE TO DEGENERATIVE DEMENTIAS. () -  Oct 5, 2022 - Abstract #CTAD2022CTAD_34;    
    This study assessed key biomarkers associated with AD to provide an exclusive set of mechanistic insights into dementia and the potential therapeutic efficacy and anti-inflammatory effects associated with NE3107 treatment in patients with MCI. Using an array of well-established neuropsychological assessments to ascertain participants’ cognitive abilities before and after treatment with NE3107, this study aimed to demonstrate the potential therapeutic efficacy and cognitive improvements associated with NE3107 treatment in patients with MCI.
  • ||||||||||  Triolex (bezisterim) / BioVie
    Trial completion:  Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia (clinicaltrials.gov) -  Sep 28, 2022   
    P2,  N=23, Completed, 
    Using an array of well-established neuropsychological assessments to ascertain participants’ cognitive abilities before and after treatment with NE3107, this study aimed to demonstrate the potential therapeutic efficacy and cognitive improvements associated with NE3107 treatment in patients with MCI. Enrolling by invitation --> Completed
  • ||||||||||  Triolex (NE3107) / BioVie
    Trial completion date, Trial primary completion date:  NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa (clinicaltrials.gov) -  Sep 16, 2022   
    P1/2,  N=40, Recruiting, 
    Enrolling by invitation --> Completed Trial completion date: Aug 2022 --> Nov 2022 | Trial primary completion date: Aug 2022 --> Nov 2022
  • ||||||||||  Triolex (NE3107) / BioVie
    Trial primary completion date:  NE3107 Activity and Safety in Patients With Parkinson's Disease Using Levodopa (clinicaltrials.gov) -  Jul 12, 2022   
    P1/2,  N=40, Recruiting, 
    Trial completion date: Aug 2022 --> Nov 2022 | Trial primary completion date: Aug 2022 --> Nov 2022 Trial primary completion date: May 2022 --> Aug 2022
  • ||||||||||  Triolex (NE3107) / BioVie
    Enrollment open:  A Phase 3 Study of NE3107 in Probable Alzheimer's Disease (clinicaltrials.gov) -  Aug 11, 2021   
    P3,  N=316, Recruiting, 
    Trial registration number: NCT04669028 (Clinicaltrials.gov). Not yet recruiting --> Recruiting