Enzymotec Ltd. Initiates Clinical Study of Vayacog in Mild Cognitive Impairment
January 20, 2015
MIGDAL HA'EMEQ, Israel, Jan. 20, 2015 (GLOBE NEWSWIRE) -- Enzymotec Ltd., (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid based nutritional ingredients and medical foods, announced today the initiation of a clinical study to evaluate the long term efficacy of Vayacog® in patients with Mild Cognitive Impairment ("MCI"). Vayacog is a proprietary prescription medical food for the dietary management of lipid imbalances associated with early memory impairment. Vayacog provides phosphatidylserine enriched with DHA, a unique lipid composition essential for the management of key biochemical modifications underlying losses in brain function.
"The initiation of this long term study is another critical step in building the pyramid of evidence to validate the use of Vayacog for the dietary management of MCI, which affects over 10% of adults over 65 and is often debilitating to their families as well," said Robert Crim, CEO VAYA Pharma, a division of Enzymotec Ltd. "Vayacog is already considered an important option to manage MCI. We expect this clinical study will provide further learnings on its impact over an extended period."
The clinical study is a 24-month, multi-center, randomized, double-blind, placebo-controlled trial comprised of 360 patients recruited in the USA and Israel. The study will examine the effect of Vayacog versus placebo on cognitive abilities, using the selective reminding test as the primary outcome.
"Vayacog's safety and short term efficacy in non-demented subjects with memory complaints was demonstrated in an earlier clinical study. By extending the timeframe of the current study over a two-year period, we expect to uncover important complementary perceptions related to the long term efficacy of Vayacog in managing MCI," said Dr. Yael Richter, Head of VAYA Pharma Research Center at Enzymotec. "Currently there is no formal approach for managing MCI and we hope to be able to deliver statistical data that result in Vayacog becoming the standard protocol."
About VAYA Pharma
VAYA Pharma is a specialty pharmaceutical division of Enzymotec Ltd. dedicated to the discovery, development, manufacture and marketing of innovative proprietary clinically tested lipid-based compositions familiar to the human body for addressing disorders that are impacted by lipid imbalances.
VAYA Pharma's medical food portfolio addresses three therapeutic segments: ADHD (Vayarin®), Early Memory Impairment (Vayacog®) and Hypertriglyceridemia (Vayarol®). VAYA Pharma products are available in the US only by prescription under the supervision of a physician. VAYA Pharma USA is headquartered in Greenville, South Carolina. For more information, visit www.vayapharma.com.
About Enzymotec Ltd.
Enzymotec is a leading global supplier of specialty lipid-based products and solutions. The Company develops, manufactures and markets innovative bio-active lipid ingredients, as well as final products, based on sophisticated processes and technologies. For more information, visit www.enzymotec.com.
Forward Looking Statements
This release may contain forward-looking statements, which express the current beliefs and expectations of Company management. Such statements involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences the following risks: we depend on third parties to obtain raw materials, in particular krill, necessary for the production of our products; a high proportion of the sales of our INFAT® product is sold to end users by a single company in China; we are subject to a degree of customer concentration and our customers do not enter into long-term purchase commitments with us; we may be required to pay royalties on sales of our krill products in North America and Australia; we have in the past, and may in the future, become subject to litigation regarding intellectual property rights or other matters; our offering of products as ''medical foods'' in the United States may be challenged by regulatory authorities; we rely on our Swedish joint venture partner to manufacture INFAT®, and have recently entered into an arbitration proceeding with our partner with respect to certain matters related to the joint agreement; we are dependent on a single facility that houses the majority of our operations; we may be impacted by delays in manufacturing as we expand our capacity; we may not be able to expand our production or processing capabilities or satisfy growing demand; our gross profits may be adversely affected if we are only able to obtain lower quality krill meal; our ability to obtain krill may be affected by conservation regulation or initiatives; our product development cycle is lengthy and uncertain, and our development or commercialization efforts for our products may be unsuccessful; we and our customers are subject to significant and increasing government regulations regarding the sale and marketing of our products and our customers' products incorporating our products; we may not be able to protect our proprietary technology or prevent its unauthorized use by third parties; and other factors discussed under the heading "Risk Factors" in the Company's Form 20-F filed with the Securities and Exchange Commission on February 13, 2014. Forward-looking statements in this release are made pursuant to the safe harbor provisions contained in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forwardlooking statements, whether as a result of new information, future events or otherwise.
KCSA Strategic Communications
Jeffrey Goldberger / Tram Bui
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