VeroScience Continues Clinical Evaluation of Bromocriptine-QR (Cycloset) and Neurophysiological Investigations of Brain Dopamine Regulation of Metabolism with Eight Papers Presented at the 2015 American Diabetes Association Conference

TIVERTON, R.I., June 6, 2015 /PRNewswire/ -- VeroScience, Inc. is pleased to be participating at the American Diabetes Association's 75^th Scientific Sessions in Boston, Mass with additional clinical data on circadian-timed morning administration of bromocriptine-QR (Cycloset), a dopamine receptor agonist, currently approved for the treatment of type 2 diabetes, and several studies relating to brain dopamine control of metabolism. A study from Dr. Bindu Chamarthi, endocrinologist at Brigham and Women's Hospital and consultant medical director to VeroScience, investigates the effects of bromocriptine-QR in type 2 diabetes subjects on high dose insulin therapy, and seven studies from VeroScience explore the interactions of brain dopamine neurons with the biological clock in the regulation of metabolism and of the body's response to diets that predispose to diabetes.

Together, the seven preclinical studies presented by VeroScience highlight the importance of the daily rhythm of brain dopamine communication with the biological clock neurons in the hypothalamus to maintain normal glucose metabolism.  These studies found that when the daily peak in this dopamine activity at the clock area is diminished by experimental manipulations, insulin resistance and glucose intolerance ensue.  Importantly, the Western diet, high in saturated fat that is well known to predispose to insulin resistance and glucose intolerance (prediabetes) in humans across the globe, also decreased daily peak dopamine signaling to the biological clock, and the prediabetic state can be attenuated by adding back dopamine to the clock neural system at the appropriate time of day. 

Dr. Anthony Cincotta, Chief Scientific Officer of VeroScience, stated, "The findings presented in these studies, as a whole, point to the critical role of brain dopamine interactions with the hypothalamic clock pacemaker system in the regulation of glucose metabolism.  They suggest that appropriately targeting and correcting aberrations in this interaction may be a simple means of improving metabolism and minimizing the adverse impact of the Westernized diet on metabolic status." 

A related study authored and presented by Dr. Bindu Chamarthi, M.D., endocrinologist, Brigham and Women's Hospital in Boston, Mass and consultant medical director, VeroScience, investigated the effects of circadian-timed daily administration of bromocriptine-QR, a potent dopamine receptor agonist (N=52), versus placebo (N=23) to individuals with type 2 diabetes whose blood glucose levels were poorly controlled on high dose insulin therapy (baseline HbA1c >/= 7.5, average HbA1c = 8.6, and total daily insulin dose >/= 70U/day).  Once daily timed (morning) bromocriptine-QR therapy improved glucose control in these study subjects over a 12-week treatment period (placebo-adjusted HbA1c decrease of -0.81 for the total study group, [P=0.0025] and -1.66 for the subgroup of subjects on metformin plus insulin at baseline [P=0.002]). 

Dr. Chamarthi stated, "These study findings are in line with the generally observed effects of timed bromocriptine-QR therapy to improve glucose metabolism without raising the plasma insulin level in type 2 diabetes subjects.  Further studies are warranted to expand upon these initial study findings as dysglycemia in this population of type 2 diabetes patients is very difficult to manage.  This therapy may offer a new means of improving glucose control in these type of diabetes patients without further increasing insulin dose."

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 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 many hours after the drug has been substantially cleared from the circulation, for example at lunch and dinner.    

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.

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