Two Peer-Reviewed Studies Focusing on Unique Therapeutic Impact of VeroScience's Cycloset Recently Published in Journal of Diabetes Research

TIVERTON, R.I., June 15, 2015 /PRNewswire/ -- VeroScience, Inc. is pleased to announce the recent publication of two studies in the Journal of Diabetes Research demonstrating the unique impact of Cycloset on patients living with type 2 diabetes. The first study, co-authored by Dr. Aaron Vinik from Eastern Virginia Medical School's Strelitz Diabetes Center, demonstrates the association between use of Cycloset and lower incidences of cardiovascular disease (CVD) events, the leading cause of death of patients living with type 2 diabetes. The second study, led by Dr. Philip Raskin at UT Southwestern Medical Center, demonstrates improved blood glucose control while simultaneously reducing the amount of daily insulin therapy in type 2 diabetes patients requiring high dose insulin therapy. 

The first paper, titled "Timed Bromocriptine-QR Therapy Reduces Progression of Cardiovascular Disease and Dysglycemia in Subjects with Well-Controlled Type 2 Diabetes," followed over 1,800 patients with type 2 diabetes who were maintaining well-controlled blood glucose (HbA1c < 7.0; average 6.3) while on up to two standard of care (SOC) anti-diabetes medications at study initiation. The one-year study examined the effects of Cycloset compared to a placebo add-on upon incidence of adverse cardiovascular disease events and on blood glucose control. Despite baseline good glucose and metabolic control (good lipid and blood pressure levels on average) with standard of care medications, these study subjects on placebo +(SOC) continued to have adverse cardiovascular events at a rate of 3.1% per year. However, Cycloset intervention, in addition to reducing the percentage of patients with worsening blood glucose (by 31%; P<0.0002 for odds ratio), was associated with a cardiovascular event rate that was 48% lower than the cardiovascular event rate associated with placebo +(SOC)(HR: 0.52; CI: 0.28-0.98).

Dr. Aaron Vinik, co-investigator of the study and Director of Research and Neuroendocrine Unit at the Eastern Virginia Medical School Strelitz Diabetes Center, stated, "These clinical findings extend the growing body of scientific evidence indicating that factors other than high blood sugar and lipid levels contribute to cardiovascular disease. Basic and clinical scientific investigations indicate that abnormally elevated sympathetic tone, a segment of the nervous system controlling metabolism, blood pressure, and cardiovascular biology, can be a major causative factor in the progression to cardiovascular disease in diabetes. Cycloset is the only anti-diabetes medication that may offer the potential ability to reduce this abnormal sympathetic nervous system activity. Additionally, Cycloset is the only medication that has been associated with such a lower incidence in cardiovascular events in diabetes patients under such study conditions within one year. Importantly, these present findings corroborate those within the total diabetes study population of 3,070 subjects having widely varying degrees of glycemic control that the present cohort derives from.  This is potentially significant because cardiovascular disease is the leading cause of death in diabetes patients. While these results suggest positive outcomes for the patients in the study, due to the study's small size the findings should be confirmed by repeat larger studies."

The second paper, "Impact of Bromocriptine-QR Therapy on Glycemic Control and Daily Insulin Requirement in Diabetes Subjects Poorly Controlled on High-Dose Insulin," followed a small group of diabetes patients taking metformin and high-dose insulin therapy over a six-month course of treatment with Cycloset. Following six months of therapy, patients who received Cycloset reduced daily insulin requirements by approximately 25% on average (P<0.009), while simultaneously improving blood glucose control (reduction of HbA1c by -1.76 from 9.74 + 0.56 to 7.98 + 0.36, P=0.01) particularly following meals (reduced blood sugar levels at 1-4 hours after a meal by 32%; P=0.04).

"These preliminary findings are interesting. Diabetes patients on such high dose insulin therapy are very difficult to manage and there are few – if any – treatment options for them that can safely improve disease status as observed in this study," stated Dr. Philip Raskin, Professor of Internal Medicine in the Division of Endocrinology at UT Southwestern Medical Center. "The current study findings are consistent with previous basic and clinical science studies indicating that Cycloset may improve insulin action. As such, substantiation of the present study findings could lead to a new and meaningful way to manage these difficult to treat 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.    

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, Inc.

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