Release Details

In Atlanta, GA, May 20-23

ATLANTA, May 20 /PRNewswire/ -- Oklahoma Foundation for Digestive Research (OFDR)-Basic Science Lab announced today that they will report on preclinical efficacy data in irritable bowel syndrome (IBS) from a study conducted with a small molecule CRF1 receptor antagonist at the Digestive Diseases Week (DDW) meeting on Sunday, May 20, 2001. In the preclinical study, conducted by Dr. Greenwood-Van Meerveld, Scientific Director of OFDR, administration of a CRF1 receptor antagonist developed by Neurocrine Biosciences was highly effective in a model of the pain and discomfort that is experienced by IBS patients. IBS is a disturbance of function of the lower intestine and colon, affecting 15-20% of the population, mainly women. IBS is characterized by three primary symptoms, altered gastrointestinal function, visceral pain or discomfort and bloating. In the study, oral administration of the compound produced a dose-dependent relief of experimentally induced visceral discomfort, with a significant effect at 0.1 mg/kg (50% response), and at higher doses responses were restored to baseline (100% response).

Numerous studies have shown a close relationship between stress resulting from life events or psychiatric disturbance and the onset and severity of IBS symptoms. Recent studies have suggested that CRF, which is believed to be a primary mediator of stress, plays an important role in the control or modulation of the gastrointestinal system. These new data suggest that CRF1 receptor antagonists may provide a new therapeutic intervention for irritable bowel syndrome, a very large and underserved market.

Dr. Greenwood-Van Meerveld commented, "The effects of Neurocrine's CRF1 receptor antagonist in our visceral hypersensitivity model were most impressive. CRF1 receptor antagonists represent an entirely new approach to the treatment of IBS, a disease which is in desperate need of effective therapies."

Neurocrine Biosciences, Inc, based in San Diego, California, is the world leader in the CRF field through its broad intellectual property portfolio and relationships with experts in the neuropsychiatric field. A single dose Phase I safety study has been successfully completed with Neurocrine's lead CRF receptor antagonist clinical compound.

Background

According to the International Foundation for Gastrointestinal Disorders (IFFGD), IBS is the most common GI disorder affecting an estimated 15-20% of adults. A substantial proportion of patient visits to primary care physicians for gastrointestinal complaints and referrals to gastroenterologists are for IBS. It is a disorder that affects the nerves and muscles of the bowel, and causes abdominal pain, irregular bowel movements, and can cause deep personal distress. Painful attacks can last from a matter of days to several months. In many cases, the cause is unknown, but stress, diet and infection can bring on or aggravate symptoms. The social and economic costs of functional GI disorders are enormous and represent an important health care burden. The symptoms of IBS heavily impact patients' lifestyles. IBS is a leading cause of worker absenteeism, second only to the common cold, with an average of 13.4 missed workdays a year among IBS patients. The disease has been estimated to result in $10.5 billion in excess direct medical expenses compared to control subjects annually in the US. Approximately 70% of IBS cases are reported in women, making this a major women's health issue and in addition is becoming one of the most common diseases in the elderly. Data has revealed that women with IBS have an increased risk of unnecessary surgery; hysterectomy or ovarian surgery and these are performed more often in IBS patients than in other comparative groups. IBS does not show any evidence of an organic or physical disease, and the cause of a functional GI disorder does not show up in traditional laboratory examinations such as blood tests or x-rays. For this reason, IBS is an under diagnosed disorder, and was formerly a "diagnosis of exclusion", meaning that it was observed only after diagnostic tests had excluded other causes. But over the past two decades, medical opinion has changed with regard to the diagnosis of IBS and an evaluation known as the "Rome II" criteria has become increasingly used by physicians to diagnose this debilitating disease.

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SOURCE Oklahoma Foundation for Digestive Research
CONTACT: Beverly Greenwood-Van Meerveld, Ph.D, of Oklahoma Foundation For Digestive Research, 405-270-0501, ext. 3547; or Alan Foster, PhD, of Neurocrine Biosciences, 858-349-2666