RALEIGH, N.C., May 4, 2015 (GLOBE NEWSWIRE) -- Islet Sciences, Inc. (OTCQB:ISLT), a biopharmaceutical company developing new medicines and technologies for the treatment and diagnosis of metabolic disease, has announced publication of pre-clinical data that demonstrates remogliflozin etabonate has significant potential as a novel therapeutic for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).
Data published in the Journal of Clinical and Experimental Hepatology show that treatment with remogliflozin etabonate for four weeks in a mouse model of NAFLD inhibited high fat diet-induced weight gain, reduced fat accumulation in the liver, and reduced serum alanine aminotransferase and aspartate aminotransferase to normal or near normal levels. In addition, remogliflozin etabonate treated animals displayed decreased inflammation in the liver, as well as lower oxidative stress. Data from this study also showed that remogliflozin has significant intrinsic anti-oxidant activity. These data along with published clinical data showing remogliflozin etabonate's ability to improve insulin sensitivity, reduce weight and lower elevated liver enzymes, strongly suggest remogliflozin etabonate as a possible therapeutic for NAFLD/NASH.
As summarized by Dr. William Wilkison, COO of Islet Sciences, "Remogliflozin etabonate addresses key pathological events involved in the development and progression of NAFLD/NASH. A phase 2b clinical study examining the ability of remogliflozin etabonate to specifically treat NAFLD/NASH will be initiated in 2015."
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 NASH/NAFLD
NAFLD occurs worldwide with a similar prevalence to obesity and type 2 diabetes. In the United States, it has emerged as the most common form of liver disease with population-based studies estimating prevalence as high as 30% of the general population. In children aged 2-19 years, the prevalence is approximately 10%. NAFLD includes a spectrum of liver disease ranging from simple steatosis (fat deposition) to necrosis and inflammation characteristic of NASH. The prevalence of NASH in the United States is up to 12%. Patients with NASH have an increased risk for disease progression to liver fibrosis (scarring) and irreversible liver damage (cirrhosis). Up to 50% of patients with NASH will develop progressive fibrosis over a 4-6 year period with up to 25% progressing to cirrhosis. NASH cirrhosis is now the third most common cause of liver transplantation in the United States. It is associated with an increased risk of hepatocellular carcinoma and mortality in patients awaiting liver transplant and can also recur post-transplant.
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.
About Kissei Pharmaceutical
Kissei Pharmaceutical Co., Ltd. was founded in 1946 and has grown into one of Japan's leading pharmaceutical companies. Kissei's management vision is to be an R&D-oriented pharmaceutical company that contributes to the health of people around world through developing and offering innovative drugs. Kissei is actively pursuing collaboration with many companies to strengthen its R&D pipeline, and also promoting the global expansion by licensing out the original agents as an important management strategy. Kissei ranks metabolism & endocrinology as one of its major R&D areas and is putting a great deal of effort into the development of novel therapeutic agents. For more information on Kissei, please see the international website http://www.kissei.co.jp/.
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.