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Re: sunspotter post# 58

Thursday, 04/23/2015 2:23:25 PM

Thursday, April 23, 2015 2:23:25 PM

Post# of 69
Which is:

" NAFLD and NASH are both closely associated with diabetes and obesity, and together are now considered a leading cause of liver disease. Consequently there is an urgent need for effective treatment options for these diseases. NASH is due, in part, to insulin resistance and oxidative stress resulting from steatosis, or accumulation of fat in the liver. A phase 2b clinical study of once-daily remogliflozin etabonate for NASH is anticipated to initiate in 2015.

In clinical studies, remogliflozin etabonate was shown to significantly improve insulin sensitivity and beta cell function, as well as reduce body weight and levels of alanine aminotransferase (ALT). In pre-clinical studies, remogliflozin etabonate significantly reduces fat accumulation in the liver and causes a marked reduction in the levels of circulating markers of oxidative stress. Unlike other drugs of its class (SGLT2 inhibitors), remogliflozin etabonate has intrinsic anti-oxidant activity, which may reverse the steatohepatitis and oxidative stress associated with the maintenance and progression of NASH.

The clinical study consisted of 336 treatment-naive subjects with type 2 diabetes and an HbA1c between 7.0% and 9.5%. Subjects were equally randomised to each of the remogliflozin etabonate treatments (50, 100, 250, 500 or 1000 mg twice daily), matching placebo or 30 mg pioglitazone (once daily). At Week 12, remogliflozin etabonate improved insulin sensitivity by 6-33% and beta cell function by 23-43%. Patients receiving remogliflozin etabonate also had significant weight loss (1.4-3.6 kg vs placebo). Importantly, post-hoc analysis of changes in ALT indicated that remogliflozin etabonate-treated subjects with elevated baseline ALT showed statistically significant (p < 0.049) mean reductions of 32-42% at Week 12 as compared to placebo.

"In multiple trials to date, remogliflozin etabonate has been shown to be a safe and potent anti-diabetic compound. In addition to its ability to reverse insulin resistance and cause weight loss, it also uniquely offers intrinsic anti-oxidant activity, which may prove useful in the treatment of patients with NAFLD and NASH," said William Wilkison, Ph.D., COO, Islet Sciences, Inc. "
http://globenewswire.com/news-release/2015/04/23/727749/10130447/en/Islet-Sciences-Inc-Presented-at-50th-International-Liver-Conference.html


§ISLT

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