Healio
Healio

EASL Congress
April 23, 2015
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Remogliflozin etabonate may play a role in treatment of fatty liver, NASH

VIENNA — With the improvement of insulin sensitivity, beta cell function, body weight and alanine aminotransferase levels, the manufacturer of an investigational SGLT2 inhibitor plans to study its role in treating fatty liver and non-alcoholic steatohepatitis, according to data presented at the 2015 International Liver Congress.

“We believe remogliflozin demonstrates a strong potential for safe and effective treatment of NAFLD and NASH,” William Wilkison, PhD, chief operating officer of Islet Sciences, said during a press conference at the congress.

In this randomized, double-blind, placebo-controlled, parallel arm study, Wilkison and colleagues looked at 336 treatment-naive patients with type 2 diabetes who were randomized to one of five doses of remogliflozin etabonate (Islet Sciences; 50 mg, 100 mg, 250 mg, 500 mg or 1,000 mg twice daily), pioglitazone 30 mg once daily or matching placebo. Efficacy and safety were assessed at baseline, 4, 8 and 12 weeks.

At 12 weeks, patients who received remogliflozin etabonate showed improvement across doses in insulin sensitivity (6% to 33%) and beta cell function (23% to 43%). All doses were associated with more weight loss (1.4 kg to 3.6 kg) than placebo or pioglitazone, which caused weight gain.

Though the study was not powered for ALT, Wilkison said post-hoc analysis showed a significant lowering of ALT across all doses of remogliflozin at 32% to 42% (P < .049) in patients with ALT elevated above 30.

Wilkison hypothesized that the lowering of ALT might be due to the “intrinsic antioxidant activity” of remogliflozin when compared to other SGLT-2 inhibitors. In a preclinical model, they saw a reduction in oxidative stress and decrease in ALT/AST, he added. Islet Sciences is planning to start a phase 2b study of remogliflozin etabonate in NASH in the second half of 2015. – by Katrina Altersitz

For More Information:

Wilkison W. Abstract O047. Presented at: International Liver Congress; April 22-26, 2015; Vienna.

Disclosure: Wilkison is an employee of Islet Sciences.