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2017 2
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Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials.
Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3; STELLAR-4 Investigators. Harrison SA, et al. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6. J Hepatol. 2020. PMID: 32147362 Clinical Trial.
Patients were randomized 2:2:1 to receive selonsertib 18 mg, selonsertib 6 mg, or placebo once daily for 48 weeks. ...The rates and types of adverse events were similar among selonsertib and placebo groups. CONCLUSIONS: Forty-eight weeks of selonsertib
Patients were randomized 2:2:1 to receive selonsertib 18 mg, selonsertib 6 mg, or placebo once daily for 48 weeks. ...The rate …
Combination Therapies Including Cilofexor and Firsocostat for Bridging Fibrosis and Cirrhosis Attributable to NASH.
Loomba R, Noureddin M, Kowdley KV, Kohli A, Sheikh A, Neff G, Bhandari BR, Gunn N, Caldwell SH, Goodman Z, Wapinski I, Resnick M, Beck AH, Ding D, Jia C, Chuang JC, Huss RS, Chung C, Subramanian GM, Myers RP, Patel K, Borg BB, Ghalib R, Kabler H, Poulos J, Younes Z, Elkhashab M, Hassanein T, Iyer R, Ruane P, Shiffman ML, Strasser S, Wong VW, Alkhouri N; for the ATLAS Investigators. Loomba R, et al. Hepatology. 2021 Feb;73(2):625-643. doi: 10.1002/hep.31622. Hepatology. 2021. PMID: 33169409 Clinical Trial.
APPROACH AND RESULTS: In this phase 2b trial, 392 patients with bridging fibrosis or compensated cirrhosis (F3-F4) were randomized to receive placebo, selonsertib 18 mg, cilofexor 30 mg, or firsocostat 20 mg, alone or in two-drug combinations, once-daily for 48 weeks. ...T …
APPROACH AND RESULTS: In this phase 2b trial, 392 patients with bridging fibrosis or compensated cirrhosis (F3-F4) were randomized to receiv …
Cirrhosis regression is associated with improved clinical outcomes in patients with nonalcoholic steatohepatitis.
Sanyal AJ, Anstee QM, Trauner M, Lawitz EJ, Abdelmalek MF, Ding D, Han L, Jia C, Huss RS, Chung C, Wong VW, Okanoue T, Romero-Gomez M, Muir AJ, Afdhal NH, Bosch J, Goodman Z, Harrison SA, Younossi ZM, Myers RP. Sanyal AJ, et al. Hepatology. 2022 May;75(5):1235-1246. doi: 10.1002/hep.32204. Epub 2022 Feb 7. Hepatology. 2022. PMID: 34662449 Free PMC article. Clinical Trial.
APPROACH AND RESULTS: Patients with compensated cirrhosis due to NASH were enrolled in two placebo-controlled trials of simtuzumab and selonsertib. Liver fibrosis at baseline and week 48 (W48) was staged by NASH Clinical Research Network (CRN) and Ishak classifications and …
APPROACH AND RESULTS: Patients with compensated cirrhosis due to NASH were enrolled in two placebo-controlled trials of simtuzumab and se
Selonsertib in adults with pulmonary arterial hypertension (ARROW): a randomised, double-blind, placebo-controlled, phase 2 trial.
Rosenkranz S, Feldman J, McLaughlin VV, Rischard F, Lange TJ, White RJ, Peacock AJ, Gerhardt F, Ebrahimi R, Brooks G, Satler C, Frantz RP; ARROW Study Group. Rosenkranz S, et al. Lancet Respir Med. 2022 Jan;10(1):35-46. doi: 10.1016/S2213-2600(21)00032-1. Epub 2021 Aug 20. Lancet Respir Med. 2022. PMID: 34425071 Clinical Trial.
Patients were stratified by PAH aetiology and background therapy, and randomly assigned (1:1:1:1) using an interactive voice-response or web-response system to placebo or selonsertib 2 mg, 6 mg, or 18 mg administered orally once daily. Both placebo and selonsertib w …
Patients were stratified by PAH aetiology and background therapy, and randomly assigned (1:1:1:1) using an interactive voice-response or web …
Selonsertib Enhances Kidney Protection Beyond Standard of Care in a Hypertensive, Secondary Glomerulosclerosis CKD Model.
Badal SS, Al Tuhaifi T, Yu YF, Lopez D, Plato CT, Joly K, Breckenridge DG, Yang HC, Liles JT, Fogo AB. Badal SS, et al. Kidney360. 2022 Apr 18;3(7):1169-1182. doi: 10.34067/KID.0001032022. eCollection 2022 Jul 28. Kidney360. 2022. PMID: 35919527 Free PMC article.
METHODS: Male Sprague Dawley rats underwent 5/6 Nx with kidney biopsy 8 weeks later for assessment of glomerulosclerosis, and were randomized to four treatment groups with equal glomerulosclerosis: selonsertib, enalapril, combination (selonsertib plus enalapril), an …
METHODS: Male Sprague Dawley rats underwent 5/6 Nx with kidney biopsy 8 weeks later for assessment of glomerulosclerosis, and were randomize …
Probing the Interaction of Selonsertib with Human Serum Albumin: In silico and In vitro Approaches.
Baig MH, Gupta P, Khan MI, Alajmi MF, Hussain A, Hassan MI, Dong JJ. Baig MH, et al. Curr Top Med Chem. 2022;22(10):879-890. doi: 10.2174/1568026622666220330012032. Curr Top Med Chem. 2022. PMID: 35352662
RESULTS: ITC results confirmed the robust binding and high affinity of selonsertib and HSA. Likewise, the fluorescence quenching results highlighted the binding affinity of selonsertib and HSA. Collectively, our findings offer deeper insight into the binding mechani …
RESULTS: ITC results confirmed the robust binding and high affinity of selonsertib and HSA. Likewise, the fluorescence quenching resu …
MAP3K kinases and kidney injury.
Cuarental L, Sucunza-Sáenz D, Valiño-Rivas L, Fernandez-Fernandez B, Sanz AB, Ortiz A, Vaquero JJ, Sanchez-Niño MD. Cuarental L, et al. Nefrologia (Engl Ed). 2019 Nov-Dec;39(6):568-580. doi: 10.1016/j.nefro.2019.03.004. Epub 2019 Jun 10. Nefrologia (Engl Ed). 2019. PMID: 31196660 Free article. Review. English, Spanish.
There is in vivo interventional evidence clearly supporting a role for MAP3K5 (ASK1) and MAP3K14 (NIK) in the pathogenesis of experimental kidney disease. Indeed, the ASK1 inhibitor Selonsertib has undergone clinical trials for diabetic kidney disease. ...
There is in vivo interventional evidence clearly supporting a role for MAP3K5 (ASK1) and MAP3K14 (NIK) in the pathogenesis of experimental k …
Pharmacokinetics, Safety, and Tolerability of Selonsertib, an Apoptosis Signal-Regulating Kinase 1 (ASK1) Inhibitor, Following First-in-Human Single and Multiple Ascending Doses in Healthy Subjects.
Nelson CH, Etchevers K, Yi S, Breckenridge D, Hepner M, Patel U, Ling J, Mathias A. Nelson CH, et al. Clin Pharmacokinet. 2020 Sep;59(9):1109-1117. doi: 10.1007/s40262-020-00878-y. Clin Pharmacokinet. 2020. PMID: 32333325 Clinical Trial.
Selonsertib was rapidly absorbed with dose-proportional PK of both parent and inactive metabolite GS-607509. There was no food effect on selonsertib PK. Renal excretion was a minor pathway of selonsertib elimination. ...
Selonsertib was rapidly absorbed with dose-proportional PK of both parent and inactive metabolite GS-607509. There was no food effect
No anti-fibrotic effect of selonsertib in NASH.
Dickson I. Dickson I. Nat Rev Gastroenterol Hepatol. 2020 May;17(5):260. doi: 10.1038/s41575-020-0297-5. Nat Rev Gastroenterol Hepatol. 2020. PMID: 32235911 No abstract available.
68 results