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BHV Pharma, Inc. Release: Clinical Study of SGLT2 Inhibitor Remogliflozin-Etabonate Demonstrates No Reduction in Effectiveness in Renally Impaired Subjects
10/3/2013 1:30:08 PM
RESEARCH TRIANGLE PARK, N.C. (October 3, 2013) BHV Pharma, a clinical-stage drug development company, announced today positive results from a clinical study of Remogliflozin Etabonate, a novel Sodium Glucose Transporter 2 (SGLT2) inhibitor. These clinical results demonstrate the effectiveness of remogliflozin in subjects with varying levels of renal insufficiency. The full results will be presented in scientific congresses in 2014.
In this single dose, parallel group study, the pharmacokinetics and pharmacodynamics of remogliflozin were studied in subjects with mild (CLcr 80-45 mL/min) and moderate (CLcr 30-49 mL/min) renal impairment and compared to matched control subjects with normal (CLcr >80 mL/min) renal function. PK parameters were comparable between subjects with varying degrees of renal insufficiency and subjects with normal renal function. In subjects with mild and moderate renal impairment, there was no statistically or clinically significant increase in AUCs and t1/2 of remogliflozin. Moreover, pharmacodynamic measurements of urinary glucose excretion indicated no alteration of the ability of remogliflozin to inhibit SGLT2 in these subjects. The percent of filtered glucose excreted was consistent across the renal function groups despite a lower filtration rate in the impaired groups. Therefore the study indicates no dose adjustment in subjects with mild or moderate renal impairment would be necessary.
These results are notable because other SGLT2 inhibitors appear to accumulate and lose efficacy in renally impaired subjects and are either not recommended for patients with reduced renal filtration or require pre-screening and regular monitoring of renal function. According to the United States Center for Disease Control, >35% of diabetics suffer from some form of renal insufficiency.
William Wilkison, BHV Chief Scientific Officer indicated, “The fact that the pharmacokinetics of remogliflozin and urinary glucose excretion were not appreciably altered suggests Remogliflozin etabonate will be safe and efficacious in renally impaired diabetics. Most importantly, these data indicate dose adjustment of Remogliflozin etabonate will not be necessary for renally impaired subjects.”
SGLT2 inhibitors are an important emerging class of compounds that will be the only orally available treatment for type 2 diabetics providing significant HbA1c lowering with clinically relevant weight loss. Importantly, SGLT2 inhibition provides patients this benefit through an insulin independent, beta-cell sparing mechanism.
About the Study
This clinical study assessed the pharmacokinetics, pharmacodynamics, and safety of Remogliflozin Etabonate in 34 subjects. This study was an open-label, single dose, parallel group design with the primary objective of studying the effects of renal impairment on pharmacokinetics and pharmacodynamics.
About Remogliflozin Etabonate
Remogliflozin etabonate is a highly selective inhibitor of SGLT2 which addresses the potential concerns of inhibiting SGLT1 in cardiac cells. Remogliflozin etabonate has been shown to reduce HbA1c greater than 1% in a statistically significant manner, presents with low incidences of urogenital infections, strong postprandial glucose disposal, and improvements in both insulin sensitivity and beta cell function in 12 week studies of type 2 diabetics. Remogliflozin etabonate has been assessed for efficacy, tolerability and safety in over 20 clinical trials, including two Phase IIb studies in type II diabetics.
About BHV Pharma
BHV Pharma is a privately held pharmaceutical company based in Research Triangle Park, North Carolina. The company is focused on developing therapeutics for the treatment of metabolic diseases. http://www.bhvpharma.com
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