ASP8232 / Astellas - LARVOL DELTA

Novel Therapies for Kidney Disease in People with Diabetes. (PubMed, J Clin Endocrinol Metab) - "Trials have yielded promising results in the search for new therapies to manage DKD. Sodium-glucose cotransporter-2 inhibitors and incretin-related therapies have demonstrated benefit and were associated with improved cardiovascular outcomes. Mineralocorticoid-receptor antagonists are another class of agents with increasing evidence of benefits."

Journal • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Ophthalmology • Renal Disease • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Mechanism-based modeling of the effect of a novel inhibitor of vascular adhesion protein-1 on albuminuria and renal function markers in patients with diabetic kidney disease. (PubMed, J Pharmacokinet Pharmacodyn) - "Through simulations, this model provided the opportunity to dissect the relationship and longitudinal association between the estimated glomerular filtration rate and albuminuria and to quantify the pharmacological effects of ASP8232. The developed drug-independent model may be useful as a starting point for other compounds affecting the same biomarkers in a similar time scale."

Clinical • Journal • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus • AOC3 • CST3

Population pharmacokinetics and pharmacodynamics of a novel vascular adhesion protein-1 inhibitor using a multiple-target mediated drug disposition model. (PubMed, J Pharmacokinet Pharmacodyn) - "The observed difference in PK between healthy volunteers and renally impaired patients could be explained by an effect of baseline estimated glomerular filtration rate on ASP8232 clearance and relative bioavailability. The relationship between ASP8232 concentration and VAP-1 inhibition was successfully established and can be applied to simulate drug exposure and degree of VAP-1 inhibition for any given dose of ASP8232 across the spectrum of renal function."

Clinical • Journal • PK/PD data • Diabetic Macular Edema • Diabetic Nephropathy • Nephrology • Ophthalmology • Renal Disease • AOC3

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease (clinicaltrials.gov) - P1/2; N=55; Completed; Sponsor: Astellas Pharma Europe B.V.; Active, not recruiting -> Completed

Trial completion • Biosimilar • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Renal Disease

A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME) (clinicaltrials.gov) - P2; N=84; Not yet recruiting; Sponsor: Astellas Pharma Europe B.V.

New P2 trial • Biosimilar • Diabetes

Efficacy of a novel inhibitor of vascular adhesion protein-1 in reducing albuminuria in patients with diabetic kidney disease (ALBUM): a randomised, placebo-controlled, phase 2 trial. (PubMed, Lancet Diabetes Endocrinol) - P2; "ASP8232 is effective in reducing albuminuria in patients with diabetic kidney disease and is safe and well tolerated. These findings warrant further research to ascertain the effect of ASP8232 on delaying progression of diabetic kidney disease."

Clinical • Journal • P2 data

Primary outcomes of the VIDI study: phase 2, double-masked, randomized, active-controlled study of ASP8232 for diabetic macular edema. (PubMed, Int J Retina Vitreous) - P2; "ASP8232 is a potent and specific small molecule vascular adhesion protein-1 (VAP-1) inhibitor. Furthermore, combination therapy did not provide additional benefit to treatment with ranibizumab alone, which significantly reduced CST and improved BCVA.Trial registration clinicaltrials.gov; NCT02302079. Registered on November 26, 2014."

Clinical • Journal • P2 data