RALEIGH, N.C., April 23, 2015 (GLOBE NEWSWIRE) -- Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment of metabolic disease, announced today that Chief Operating Officer, Dr. William Wilkison presented "Remogliflozin Etabonate Reduces Insulin Resistance and Liver Function Enzymes: Role for Treatment of NASH" at the 50th International Liver Conference hosted by the European Association for the Study of Liver (EASL) in Vienna, Austria.
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.
About Remogliflozin
Remogliflozin is a selective SGLT2 inhibitor in phase 2b clinical development for NASH and type 2 diabetes. Remogliflozin has been dosed in over 800 people in more than twenty clinical trials. In twelve-week phase 2b clinical studies, remogliflozin demonstrated HbA1c lowering greater than 1% with no significant adverse events and low incidence rates of genitourinary infections and little or no increases in LDLc, common side effects associated with SGLT2 inhibitors. Remogliflozin also demonstrated strong postprandial glucose disposal and improvements in both insulin sensitivity and beta cell function. In patients with impaired renal function, remogliflozin showed little plasma accumulation relative to patients with normal renal function and, therefore, no dose adjustment is expected for this large (>35%) segment of the diabetic population. The review by a central IRB and the U.S. Food and Drug Administration of the protocol for a phase 2b clinical study of remogliflozin was conducted in late 2014. Clinical site selection is underway with dosing expected to commence Q2 of 2015. The study is designed as a 12-week double blind, placebo controlled, and dose-ranging study of once-daily remogliflozin in type 2 diabetics. A phase 2b clinical study of remogliflozin for NASH is anticipated to initiate in 2015.
About Islet Sciences
Islet Sciences, Inc., a biopharmaceutical company based in Raleigh, NC, is developing new medicines and technologies for the treatment of metabolic disease. In addition to remogliflozin, the Company's pipeline includes immune-modulating small molecule IL-12 antagonists targeting beta-cell preservation and inflammation, a cell-based transplantation therapy for insulin-dependent diabetes, and a PCR-based molecular diagnostic measuring beta-cell loss for the diagnosis of type 1 diabetes or onset of insulin-dependent type 2 diabetes. On March 3, 2015, Islet Sciences, Inc. ("Islet") entered into an exclusive license agreement with Brighthaven Ventures, L.L.C. for rights to develop and commercialize a novel SGLT2 inhibitor, remogliflozin etabonate, in the licensed territory. The exclusive license will only become effective upon Islet raising a minimum of $10 million and paying BHV the upfront fee by May 31, 2015. For more information, please visit http://www.isletsciences.com.
Forward-Looking Statements
This press release contains forward-looking statements. Forward-looking statements reflect current expectations as of the date of this press release and involve certain risks and uncertainties. Actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, and such forward-looking statements are not predictions of future events. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the Company's ability to raise the minimum $10 million of funding required by the license agreement, the failure of the license agreement to become effective by May 31, 2015, the Company's ability to develop and commercialize remogliflozin, and the other risks described in Islet Science, Inc.'s reports filed with the Securities and Exchange Commission. The development and commercialization of remogliflozin is highly dependent on future medical and research developments and market acceptance, which are outside of Islet's control.