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  • ||||||||||  govorestat (AT-007) / Applied Therap
    Development of Govorestat (AT-007), the First Potential Treatment for Patients with Classic Galactosemia (Magnolia Auditorium | Level -1) -  Aug 21, 2024 - Abstract #SSIEM2024SSIEM_1091;    
    Learnings on Classic Galactosemia from the first longitudinal study in children will be discussed, such as the progressive worsening of clinical function and widening gap between Classic Galactosemia patients and their normative peers. The effects of govorestat (a CNS penetrant aldose reductase inhibitor) on galactitol (a toxic metabolite of galactose formed in patients with Classic Galactosemia) and the effects of govorestat on long-term clinical outcomes will be presented.
  • ||||||||||  govorestat (AT-007) / Applied Therap
    Trial completion date, Trial primary completion date:  Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia (clinicaltrials.gov) -  Jul 30, 2024   
    P2/3,  N=47, Active, not recruiting, 
    The effects of govorestat (a CNS penetrant aldose reductase inhibitor) on galactitol (a toxic metabolite of galactose formed in patients with Classic Galactosemia) and the effects of govorestat on long-term clinical outcomes will be presented. Trial completion date: Sep 2023 --> Dec 2024 | Trial primary completion date: Apr 2023 --> Dec 2024
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Journal:  Randomized Trial of a Selective Aldose (Pubmed Central) -  Jul 3, 2024   
    P3
    In conclusion, govorestat displayed a favorable safety, PK, and PD profile in humans, and reduced galactitol levels in the same magnitude (?50%) as in a rat model of CG that demonstrated an efficacy benefit on neurological, behavioral, and ocular outcomes. Among individuals with DbCM and impaired exercise capacity, treatment with AT-001 for 15
  • ||||||||||  Review, Journal:  Highlights of Cardiovascular Disease Prevention Studies Presented at the 2024 American College of Cardiology Conference. (Pubmed Central) -  Jun 3, 2024   
    The AEGIS-II randomized patients with type 1 myocardial infarction (MI) with multivessel coronary artery disease and additional CV risk factors and found no benefit in major adverse CV events (MACE) with CSL112, an apolipoprotein A1 infusion shown to increase cholesterol efflux capacity. The Bridge-TIMI 73a trial showed a significant reduction in triglyceride (TG) levels with olezarsen, an antisense mRNA, in patients with moderate hyperTG with elevated CV risk...The VICTORIAN-INITIATE trial showed efficacy and safety in early use of inclisiran in patients with ASCVD who did not reach target LDL-C?<?70
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Relationship between NT-proBNP, echocardiographic abnormalities and functional status in patients with subclinical diabetic cardiomyopathy (Station 2 - Research Gateway) -  May 14, 2024 - Abstract #ESC2024ESC_2283;    
    Among highly selected patients with subclinical DbCM, elevated NT-proBNP concentrations are associated with worse health status, lower activity levels, and reduced functional capacity, but not with cardiac structural abnormalities. These findings suggest that regardless of cardiac structural abnormalities, biomarker concentrations reflect important deterioration in functional capacity in affected individuals.
  • ||||||||||  AT-003 / Applied Therap
    Journal:  Complete genome sequence of Cellulomonas sp. strain ATA003. (Pubmed Central) -  May 2, 2024   
    strain ATA003 was isolated from the endemic cactus Maihueniopsis domeykoensis seeds collected in the Coastal Atacama Desert, Chile. Here, we present a circular genome with a size of 4,084,881 bp and a GC content of 73.8% obtained by Nanopore sequencing.
  • ||||||||||  AT-001 / Applied Therap
    N-Terminal Pro-B Type Natriuretic Peptide Concentrations in Diabetic Cardiomyopathy (Poster Halls B-C; [Board No. 450]) -  Apr 10, 2023 - Abstract #ADA2023ADA_2569;    
    P3
    The ARISE-HF study (NCT04083339) is evaluating efficacy of AT-001, a highly selective aldose reductase inhibitor (AT-001) to improve exercise tolerance in affected patients... Among patients with DbCM, elevated NT-proBNP is associated with echocardiographic abnormalities and worse cardiac functional capacity and inversely associated with activity.
  • ||||||||||  AT-001 / Applied Therap
    The Face of Diabetic Cardiomyopathy (Poster Halls B-C; [Board No. 1238]) -  Apr 10, 2023 - Abstract #ADA2023ADA_597;    
    P3
    The ARISE-HF trial is an ongoing phase 3 clinical trial evaluating the safety and efficacy of aldose reductase inhibition on exercise capacity in patients with DbCM. The baseline analysis of the study cohort provides a unique characterization of individuals with DbCM.
  • ||||||||||  AT-001 / Applied Therap
    NT-proBNP levels in diabetic cardiomyopathy: results from the ARISE-HF trial (Moderated ePosters 2) -  Feb 28, 2023 - Abstract #HEARTFAILURE2023HEART_FAILURE_636;    
    Main baseline characteristics were similar across baseline NT-proBNP concentrations, however participants with higher NT-proBNP levels had a greater left atrial volume (LAVI) (p<0.001) and higher right ventricular systolic pressure (p=0.04) on baseline echocardiogram. Higher NT-proBNP concentrations were associated with reduced physical activity reflected in lower Physical Activity Scale for the Elderly (PASE) Score (p<0.001) and a worse quality of life defined by a lower mKCCQ score (p=0.02).
  • ||||||||||  govorestat (AT-007) / Applied Therap
    Trial completion date, Trial primary completion date:  Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia (clinicaltrials.gov) -  Feb 24, 2023   
    P2/3,  N=47, Active, not recruiting, 
    Higher NT-proBNP concentrations were associated with reduced physical activity reflected in lower Physical Activity Scale for the Elderly (PASE) Score (p<0.001) and a worse quality of life defined by a lower mKCCQ score (p=0.02). Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Apr 2022 --> Apr 2023
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Enrollment closed:  ARISE-HF: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (clinicaltrials.gov) -  Dec 8, 2022   
    P3,  N=675, Active, not recruiting, 
    Trial completion date: Jun 2023 --> Sep 2023 | Trial primary completion date: Apr 2022 --> Apr 2023 Recruiting --> Active, not recruiting
  • ||||||||||  AT-001 / Applied Therap, Kinedak (epalrestat) / Ono Pharma
    Journal:  CADD Studies in the Discovery of Potential ARI (Aldose Reductase Inhibitors) Agents for the Treatment of Diabetic Complications. (Pubmed Central) -  Aug 24, 2022   
    AR inhibitors (ARI) have been widely discussed in the literature, for example, Epalrestat is currently the only ARI used to treat patients with diabetic neuropathy in Japan, India, and China...AT-001, an AR inhibitor, is now being tested in COVID-19 to see how safe and effective it is at reducing inflammation and cardiac damage...New data shows that diabetes and obesity are among the strongest predictors of COVID-19 hospitalization. Patients and risk factors for severe morbidity and mortality of COVID- 19.
  • ||||||||||  govorestat (AT-007) / Applied Therap
    Trial completion, Trial completion date:  Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia (clinicaltrials.gov) -  Jun 3, 2022   
    P1/2,  N=100, Completed, 
    Many patients with DbCM have reduced their daily physical activities to mitigate the presentation of symptoms of fatigue; however, their quality of life is significantly affected by the disease even before the progression to overt HF. Active, not recruiting --> Completed | Trial completion date: May 2022 --> Dec 2021
  • ||||||||||  govorestat (AT-007) / Applied Therap
    Enrollment closed, Trial completion date, Trial primary completion date:  Safety and Pharmacokinetics of AT-007 in Healthy Subjects and in Adult Subjects With Classic Galactosemia (clinicaltrials.gov) -  Mar 3, 2022   
    P1/2,  N=100, Active, not recruiting, 
    Any treatment that could reduce symptoms or slow functional decline would ease the burden of this condition on patients and caregivers. Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Jun 2020 --> Dec 2021
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Trial completion date, Trial primary completion date:  ARISE-HF: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (clinicaltrials.gov) -  Feb 28, 2022   
    P3,  N=675, Recruiting, 
    Recruiting --> Active, not recruiting | Trial completion date: Dec 2021 --> May 2022 | Trial primary completion date: Jun 2020 --> Dec 2021 Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  govorestat (AT-007) / Applied Therap
    Enrollment closed, Trial primary completion date:  Clinical Benefit, Safety, PK and PD Study of AT-007 in Pediatric Subjects With Classic Galactosemia (clinicaltrials.gov) -  Feb 16, 2022   
    P2/3,  N=47, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023 Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2021 --> Apr 2022
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Enrollment change:  Cardiovascular Effects of COVID-19 (clinicaltrials.gov) -  Sep 16, 2021   
    P2,  N=81, Completed, 
    While the observed trend did not reach statistical significance, the present study provides the rationale for investigating potential benefit of AT-001 in COVID 19 affected patients in future studies. N=10 --> 81
  • ||||||||||  AT-001 / Applied Therap
    [VIRTUAL] Diabetic Cardiomyopathy: An Opportunity for Clinical Intervention () -  Jun 25, 2021 - Abstract #ADA2021ADA_2755;    
    There are currently no approved treatments for DbCM. The ARISE-HF clinical trial is currently enrolling patients and studying the ability of AT-001, a novel, potent, selective Aldose Reductase Inhibitor, to halt or prevent progression of Diabetic Cardiomyopathy.
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Trial completion date, Trial primary completion date:  ARISE-HF: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (clinicaltrials.gov) -  Jun 10, 2021   
    P3,  N=675, Recruiting, 
    The ARISE-HF clinical trial is currently enrolling patients and studying the ability of AT-001, a novel, potent, selective Aldose Reductase Inhibitor, to halt or prevent progression of Diabetic Cardiomyopathy. Trial completion date: Sep 2023 --> Dec 2024 | Trial primary completion date: Sep 2021 --> Dec 2022
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Trial completion, Enrollment change:  Cardiovascular Effects of COVID-19 (clinicaltrials.gov) -  Feb 24, 2021   
    P2,  N=10, Completed, 
    Trial completion date: Dec 2019 --> Dec 2021 | Trial primary completion date: Dec 2019 --> Jun 2020 Recruiting --> Completed | N=500 --> 10
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    New P2 trial:  Cardiovascular Effects of COVID-19 (clinicaltrials.gov) -  Apr 27, 2020   
    P2,  N=500, Recruiting, 
  • ||||||||||  AT-001 / Applied Therap, ATL 001 / Achilles Therap
    ATL001 (STARLIGHT BALLROOM) -  Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_113;    
  • ||||||||||  AT-007 / Applied Therap, AT 005 / Androclus
    Journal:  Comparison of Two Series Elastic Actuator Designs Incorporated into a Shoulder Exoskeleton. (Pubmed Central) -  Jan 18, 2020   
    For arm rotation, the step response rise time was.03 s, and impedance peaked at.023 Nm/deg during 3.5 Hz oscillations. Both SEA designs had performance measurements that were similar to other SEA designs in terms of torque tracking, but with much lower impedance than previously reported.
  • ||||||||||  caficrestat (AT-001) / Applied Therap
    Enrollment open:  ARISE-HF: Safety and Efficacy of AT-001 in Patients With Diabetic Cardiomyopathy (clinicaltrials.gov) -  Oct 15, 2019   
    P3,  N=675, Recruiting, 
    Both SEA designs had performance measurements that were similar to other SEA designs in terms of torque tracking, but with much lower impedance than previously reported. Not yet recruiting --> Recruiting