TIVERTON, R.I., June 11, 2016 /PRNewswire/ -- VeroScience LLC, is pleased to announce the presentation of six papers at the 76th Scientific Sessions of the American Diabetes Association in New Orleans, La. evaluating their FDA-approved drug Cycloset® (bromocriptine-QR) for the treatment of Type 2 diabetes and its platform technology. Supported by the Company's continuous commitment to clinical research and its registered Circadian Neuroendocrine Resetting Therapy® (CNRT), Cycloset studies continue to demonstrate that the therapy improves glycemic control in individuals with Type 2 diabetes, and reduces risk factors for cardiovascular disease (CVD), as reaffirmed in research to be presented this June.
Research conducted by the VeroScience team of scientists to be presented at the 2016 ADA includes the following:
- Circadian Dopamine Activity at the Biological Clock Regulates Insulin Sensitivity via the Hypothalamus – Established that circadian-time dependent administration of dopamine to the biological clock pacemaker -suprachiasmatic nuclei (SCN) reduces insulin resistance in part by reducing over activity of hypothalamic nuclei that potentiate increases in sympathetic drive to the periphery.
- Inhibition of the Supramammillary Nucleus Activity Alters Clock Photosensitivity and Induces Metabolic Syndrome – Demonstrates that inhibition of Supramammillary Nucleus neurons (SuMNi) resets the clock (SCN) response to the photoperiod (alters its interpretation of light) and induces metabolic syndrome: a potential neuronal circuit involved in the adverse effects of sleep disruption on metabolism.
- Dopamine Agonists Reverse Hyperglycemia in Streptozotocin-induced Diabetic Mice – Demonstrates that dopamine agonist therapy that activates both the D1 and D2 receptors ameliorates hyperglycemia of STZ-treated diabetic mice without altering the plasma insulin level. These results have positive implications for the treatment of both type 1 and type 2 diabetes.
- The Anti-diabetes Effect of Leptin in Streptozotocin Treated Mice is Blocked by Dopamine Antagonism – Provides evidence that the anti-diabetes effects of leptin in the absence of insulin are mediated or facilitated by dopamine action.
- VMH Glucose Sending Neurons are Altered by High Fat Diet Sensitivity to Facilitate Dysglycemia – Suggests that high saturated fat feeding alters glucose sensing neuron activities in the VMH to 1) aberrantly potentiate counter-regulatory hyperglycemic responses during euglycemia, and 2) reduce activity of glucose excitatory neurons that may result in diminished post-meal insulin sensitization.
When taken in total, these five presentations identify the critical role of circadian dopaminergic activity at the biological clock system within the brain in maintaining healthy metabolism. These studies highlight the multiple neurophysiological pathways known to modulate fuel metabolism that are deranged in metabolic disease states such as T2DM and that are corrected by circadian dopaminergic clock neurophysiological interactions. These studies provide mechanistic insights into the sympatholytic, insulin sensitizing effects of Cycloset therapy for T2DM.
Additionally, a clinical presentation by Dr. Bindu Chamarthi of Brigham and Women's Hospital in Boston, MA highlighted the unique simultaneous beneficial effects of Cycloset therapy to reduce elevated resting heart rate and dysglycemia in T2DM subjects.
- Dopamine Agonist Therapy Reduces Elevated Heart Rate and Dysglycemia in Type 2 Diabetes Subjects – Identifies a sympatholytic mechanism for Cycloset-induced reduction of both elevated resting heart rate (RHR) and HbA1c in T2DM subjects.
"Mounting evidence from several clinical studies strongly suggests that high resting heart rate, most often a result of elevated sympathetic tone, is a serious risk factor for metabolic syndrome, T2DM, and cardiovascular disease. There are few if any oral anti-diabetes therapies that can reduce both high resting heart rate and hyperglycemia in T2DM patients, and these study results demonstrate that bromocriptine-QR is one potential therapy that is capable of doing so. These study findings align well with previous research that show a reduction in adverse cardiovascular outcomes with bromocriptine-QR therapy," said Dr. Chamarthi.
"I'm pleased with the team at VeroScience for continuing our commitment to scientific excellence and research that supports our CNRT platform," said Dr. Anthony Cincotta, Chief Scientific Officer of VeroScience. "With these six papers and the additional study from Dr. Ralph DeFronzo's group this year, following eight papers presented last year at the ADA Scientific Sessions, we are actively continuing our evaluation of the clinical applications of this platform, and are pleased to offer an excellent therapy for patients struggling with Type 2 diabetes. Moving towards broader market availability of Cycloset, we're pleased to see that research continues to support this drug as an excellent option for type 2 diabetes patients."
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.
VeroScience LLC, 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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