PROLOR Biotech Announces Positive Results of Its Obesity/Diabetes Drug Candidate in Preclinical Weight Loss Study
—MOD-6030 Administered Once Weekly Over 30 Days Produced 28% Weight Loss and Improved Glycemic Profiles—
—Other Potential Health Benefits Included 57% Reduction in Cholesterol Levels—
—Data to Be Presented at 5th Diabetes Drug Discovery and Development Conference—
NES-ZIONA, Israel, April 17, 2012 /PRNewswire/ -- PROLOR Biotech, Inc. (NYSE Amex: PBTH) today reported positive preclinical results from an animal study of its long-acting obesity/Type II diabetes drug candidate MOD-6030. The study was designed to measure the potential therapeutic effect of MOD-6030 injected once weekly as measured by weight loss, reduction in food intake, glycemic control and cholesterol levels. The study results will be presented at GTC's 5th Diabetes Drug Discovery and Development Conference on April 19, 2012 in Boston, MA.
In the study, MOD-6030 administered to diet-induced obese (DIO) mice once weekly over a 30-day period demonstrated significant efficacy in reducing weight, lowering blood glucose levels, increasing insulin sensitivity and reducing cholesterol levels as compared to a group that received placebo. Animals in the placebo group showed minimal changes in the study parameters, while the animals receiving MOD-6030 achieved on average a 28% reduction in weight, a 29% reduction in food intake, a 19% reduction in blood glucose levels and a 57% reduction in cholesterol levels. Body composition analysis showed that the weight loss resulted specifically from reductions in body fat.
"We believe there is great demand among obese patients and their physicians for therapies that will help patients lose weight and reduce elevated glucose levels resulting from obesity with minimal side effects and a favorable administration profile," said Dr. Abraham Havron, CEO of PROLOR. "In this study in animals, our MOD-6030 therapy demonstrated a unique combination of achieving substantial weight loss and improved glycemic profiles while also significantly lowering cholesterol levels."
Dr. Havron continued, "MOD-6030 is a long-acting version of a native peptide that acts as a natural satiety signal to reduce food intake, and we believe it has the potential be a major new treatment for obesity and Type II diabetes that is both effective and safe. We are currently on track to initiate the first human clinical trial of MOD-6030 in 2013."
MOD-6030, a GLP-1/Glucagon dual receptor agonist peptide, is a long-acting version of oxyntomodulin, a naturally occurring hormone that acts as a natural satiety signal to reduce food intake and increase energy expenditure following food ingestion. Previous third-party studies in humans showed that the native oxyntomodulin can reduce appetite and food intake, leading to significant weight loss without apparent side effects. However, as a result of its very short half-life, oxyntomodulin has to be administered via three daily injections. PROLOR developed MOD-6030, its longer-acting version, by combining the naturally occurring hormone with the company's proprietary Reversible PEGylation technology designed to increase the half-life of therapeutic peptides and small molecules.
For more information on the 5th Diabetes Drug Discovery and Development Conference, visit www.gtcbio.com/component/conference/?file=home&cn=5th+Diabetes+Drug+Discovery+&Development=&cid=16.
PROLOR Biotech, Inc. is a clinical stage biopharmaceutical company applying unique technologies, including its patented CTP technology, primarily to develop longer-acting proprietary versions of already approved therapeutic proteins that currently generate billions of dollars in annual global sales. The CTP technology is applicable to virtually all proteins. PROLOR is currently developing a long-acting version of human growth hormone, which has successfully completed a Phase II clinical trial. It also is developing long-acting versions of Factor VIIa and Factor IX for hemophilia and a GLP-1/Glucagon dual receptor agonist peptide for diabetes and obesity, as well as agents for atherosclerosis and rheumatoid arthritis, which are all in preclinical development. For more information, visit www.prolor-biotech.com.
Safe Harbor Statement: This press release contains forward-looking statements, which may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "would", "intends," "estimates," "suggests," "has the potential to" and other words of similar meaning, including statements regarding the results of current clinical studies and preclinical experiments and the effectiveness of PROLOR's long-acting protein programs, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that forward-looking statements involve risks and uncertainties that may affect PROLOR's business and prospects, including the risks that PROLOR may not succeed in generating any revenues or developing any commercial products, including any long-acting versions of human growth hormone, erythropoietin, interferon beta, GLP-1 and other products; that the long-acting products in development may fail, may not achieve the expected results or effectiveness and/or may not generate data that would support the approval or marketing of these products for the indications being studied or for other indications; that ongoing studies may not continue to show substantial or any activity; that the actual dollar amount of any grants from Israel's Office of the Chief Scientist is uncertain and is subject to policy changes of the Israeli government, and that such grants may be insufficient to assist with product development; and other risks and uncertainties that may cause results to differ materially from those set forth in the forward-looking statements. The results of clinical trials in humans may produce results that differ significantly from the results of clinical and other trials in animals. The results of early-stage trials may differ significantly from the results of more developed, later-stage trials. The development of any products using the CTP platform technology could also be affected by a number of other factors, including unexpected safety, efficacy or manufacturing issues, additional time requirements for data analyses and decision making, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing and the impact of patents and other proprietary rights held by competitors and other third parties. In addition to the risk factors described above, investors should consider the economic, competitive, governmental, technological and other factors discussed in PROLOR's filings with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law.
SOURCE PROLOR Biotech, Inc.