Published Review Paper from VeroScience Delineates 50 Years of Research Linking Circadian Rhythms with Metabolic Disease

TIVERTON, R.I., March 16, 2016 /PRNewswire/ -- VeroScience, Inc., is pleased to announce that the prestigious Expert Review of Endocrinology & Metabolism has published a comprehensive review of circadian rhythms (24 hour rhythms of biological activities) research from the VeroScience scientific team. These studies, dating back over 50 years, were the first to delineate important roles for circadian rhythms of biological activities in the regulation of body metabolism. Preclinical and clinical studies have shown that manipulating these rhythms through Circadian Neuroendocrine Resetting Therapy® (CNRT) can treat a number of metabolic and chronic conditions, and this work led to the development of the Company's FDA approved drug, Cycloset, for the treatment of Type 2 Diabetes.

Initially, studying the natural circadian rhythms of animals in the wild during different seasons of the year, VeroScience researchers concluded that the obese insulin resistant/glucose intolerant state predisposing to diabetes evolved in vertebrates as a seasonal survival mechanism when food availability varied with the seasons. Animals prepare for seasons of food scarcity by becoming insulin resistant, allowing better management of fat fuel supplies and a glucose supply to the brain during prolonged reduced food availability/starvation. Interestingly, when this season passes and food is plentiful again, this insulin resistance – prediabetes – vanishes. Through their studies, however, researchers concluded this 365-day annual cycle of metabolism is primarily regulated by seasonal changes in the temporal interactions of circadian (24 hour) neuroendocrine rhythm activities, not food availability.

For some people, exposure to the western diet appears to "lock" these circadian activities into this seasonal insulin resistant/glucose intolerant pattern, which presents as prediabetes, all year long, which then predisposes to metabolic disease. Using this knowledge, researchers were able to identify a platform to manipulate these deranged rhythms in humans to reset them towards their natural state, allowing better control of metabolism. This therapeutic process, termed Circadian Neuroendocrine Resetting Therapy®, is a core platform technology of VeroScience that can potentially be used to treat a host of chronic diseases. Through timed daily administration of Cycloset, a drug used to treat type 2 diabetes whose development was based on this platform, individuals with diabetes experience improved blood sugar control and a 42% reduction in adverse cardiovascular disease outcomes, as described in scientific articles published in Diabetes Care, Journal of American Heart Association, Endocrine Practice, and Journal of Diabetes Research, among others.

"Over many decades, the VeroScience research team has identified critical biological clock activities in the brain that are major regulators of metabolism," shared Dr. Stanley Schwartz, associate, Main Line Health. "Alterations in these brain control centers induced by factors in daily western life, high carbohydrate and fatty diets, abnormal sleep and wake cycles, stress, and inactivity all act to reprogram brain clock regulation of metabolism in a way that facilitates insulin resistance and predisposes to diabetes.  Targeting these disrupted brain clock activities to reset them towards normal has led to an effective therapeutic Cycloset, to treat and assist diabetes patients in contributing to their own cardiometabolic care and overall wellbeing."

"We are pleased to showcase the collective impact and research that has been done to support the development and success of CNRT Platform and Cycloset in the treatment and management of diabetes, a major public health crisis," said Anthony Cincotta, chief scientific officer at VeroScience. "We remain focused on research in this field to develop new therapies for metabolic diseases. Following FDA approval in 2009, we have continued studying Cycloset function, leading to expanded labeling on its mechanism of action, approved by FDA in late  2015, to reflect the sympatholytic and insulin sensitizing properties of Cycloset."

About Cycloset and the Biological Clock
Preclinical studies indicate that while an increase in dopamine activity leads to improvements in diabetes, the time of day of the increased dopamine activity is also important. Studies in diabetic animals have shown that increased dopaminergic activity at a particular time of day is most effective in "resetting" the biological clock neurochemistry to a physiology that improves diabetic dysmetabolism. Taken orally, once-a-day, in the morning, Cycloset provides a single brief pulse of dopamine agonist activity shortly after its administration. Morning Cycloset improves post-prandial (post meal) glucose without increasing plasma insulin concentrations and the beneficial effects of Cycloset on post-meal glycemic control in patients with Type 2 diabetes are demonstrable throughout the meals of the day.    

About VeroScience
VeroScience is a privately held biotechnology and healthcare product development company with main offices and laboratories in Tiverton, R.I. VeroScience holds the NDA and related intellectual property for Cycloset and has a large patent portfolio that supports its preclinical and clinical development programs and product pipeline in the areas of metabolism, immunology and oncology. VeroScience leverages its intellectual property and products in out-licensing and collaborative arrangements with appropriate industry partners.

SOURCE VeroScience

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