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Rhythm Announces Study Demonstrating High Prevalence of Diabetic Gastroparesis Symptoms in the U.S.

BOSTON, May 20, 2013 /PRNewswire/ -- Rhythm announced today the presentation of results from a new epidemiology study demonstrating a higher prevalence of gastroparesis symptoms among diabetic patients in the U.S. than previously recognized. Prevalence of these symptoms is high among patients with both type 1 and type 2 diabetes, but this condition is significantly under-diagnosed among those with the more common type 2 disease.

Lee M. Kaplan , MD, PhD, Associate Professor of Medicine at Harvard Medical School and Director of the Obesity, Metabolism, & Nutrition Institute at the Massachusetts General Hospital, described the study, "High Prevalence and Under-Diagnosis of Gastroparesis Symptoms Among Patients with Type 1 and Type 2 Diabetes Mellitus," in an oral presentation at the annual meeting of the American Gastroenterological Association, during the Digestive Disease Week 2013 conference in Orlando, Florida.

The primary objective of this study was to measure the prevalence and severity of symptoms among diabetic patients in the U.S. Estimates of the prevalence of diabetic gastroparesis have been highly variable, ranging from 100,000 to 2.3 million adults in the U.S. Previous studies have used varying diagnostic criteria and have generally been based on geographically limited populations. This study was a national, population-based assessment.

"There have been conflicting estimates of the prevalence of diabetic gastroparesis in the U.S.," said Dr. Kaplan. "Given the variability in clinical presentation and testing outcomes, patient symptoms have been widely recognized as the key measure of the effectiveness of different therapies. This symptom-based examination of disease prevalence thus provides a relevant assessment of the population in need of such therapies. The surprisingly high prevalence of gastroparesis symptoms in patients with type 2 diabetes suggests a need for greater awareness of this complication and an opportunity for improved treatment of type 2 diabetics overall."

Results and conclusions from the study:

  • Nearly 50% of patients with either type 1 or type 2 diabetes reported experiencing one or more gastroparesis symptoms during the prior seven days, and more than 40% of these symptoms were reported to be moderate or severe. The majority of patients reporting moderate to severe symptoms had sought medical care for evaluation and treatment of these symptoms.
  • Results from this national sample suggest that approximately 165,000 type 1 (14% of type 1 diabetics in the U.S.) and 2.1 million type 2 diabetics (9.4%) are currently seeking treatment for gastroparesis symptoms and have had moderate or severe symptoms of gastroparesis within the previous seven days.
  • The prevalence of gastroparesis symptoms is higher—yet less commonly diagnosed—than previously reported, particularly among the large and growing population with type 2 diabetes.
  • Despite similar symptoms, patients with type 2 diabetes are less likely to be fully evaluated for gastroparesis and are much less commonly diagnosed with this disorder than are patients with type 1 diabetes.

"This new work reflects how common symptoms of gastroparesis are in patients with both type 1 and type 2 diabetes," said Kenneth L. Koch , MD, Professor of Internal Medicine and Head, Section on Gastroenterology at Wake Forest School of Medicine, and an author on the study. "Overall, gastroparesis patients do not have gallbladder disease, they do not have peptic ulcer disease, they do not have irritable bowel syndrome--they have stomach motility disorders that range from gastric dysrhythmias to gastroparesis. Physicians need to be more aware of this constellation of symptoms so that they proceed with the diagnostic tests necessary to establish gastroparesis as the cause of the patient's symptoms."

"This careful study shows that diabetic gastroparesis is indeed a relatively common problem and one that is definitely under-recognized and perhaps underappreciated in the U.S.," said Richard W. McCallum , MD, Professor and Founding Chairman of the Department of Internal Medicine, Texas Tech University. "This study reminds us that not only is type 2 diabetes predominant, but that symptoms consistent with gastroparesis are very common in these patients. This is probably the future of diabetes--that we'll be seeing more and more gastroparetics that are of type 2 etiology. As clinicians, we need to be more focused on type 2 diabetics and do more diagnostic testing that will lead to treatment, hopefully at an earlier stage."

About the Diabetic Gastroparesis Epidemiology Study    
The goal of the study was to determine the prevalence of gastroparesis symptoms and diagnosis among U.S. adults with diabetes using a population-based survey. The study assessed the symptoms of diabetic gastroparesis among a national sample of 911 patients with type 1 and type 2 diabetes using a novel symptom assessment tool being developed specifically for diabetic gastroparesis symptoms following FDA guidelines for Patient Reported Outcomes (PRO) development for this disorder. Patients were administered a questionnaire to record their gastroparesis symptoms and severity over the most recent 24 hours and seven days, specifically for the symptoms of bloating, abdominal pain, nausea, vomiting, and postprandial fullness. The survey also assessed these patients for disease history, diagnosis of gastroparesis, comorbidities, glycemic control, and current medication use. This study was funded by Rhythm.

About RM-131   
RM-131 is in Phase 2 clinical trials for the treatment of diabetic gastroparesis and lower GI functional disorders. RM-131 is a small-peptide analog of ghrelin, a hormone produced in the stomach that stimulates gastrointestinal activity. Derived from the natural ghrelin sequence, RM-131 has been optimized to stimulate gastrointestinal motility, with greater potency and enhanced stability and pharmacokinetics. The U.S. Food and Drug Administration (FDA) has granted Fast Track review status to RM-131 for the treatment of diabetic gastroparesis.

About Gastroparesis 
Gastroparesis affects a significant number of the 24 million diabetics in the U.S; there are 2.3 million type 1 and type 2 diabetic patients with moderate or severe gastroparesis symptoms who are seeking treatment. Gastroparesis symptoms include chronic nausea, vomiting, and malnutrition and results in a significant rate of hospitalization. This condition also often undermines measures to manage hyperglycemia.

About Rhythm (   
Rhythm is a biotechnology company developing peptide therapeutics that address unmet needs in metabolic diseases. Rhythm is developing the ghrelin peptide agonist, RM-131, for the treatment of diabetic gastroparesis and other GI functional disorders; and the MC4R peptide agonist, RM-493, for obesity and diabetes. Rhythm investors include MPM Capital, New Enterprise Associates, Third Rock Ventures, Ipsen, and Pfizer Ventures. The company is based in Boston, Massachusetts.

Bart Henderson 
(857) 264-4281

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