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Napo Announces Positive Clinical Data Indicating Crofelemer, Could Effectively Treat Cholera

Tuesday, September 23, 2008 General News
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SAN FRANCISCO, Sept. 22 Napo Pharmaceuticals (LSE: NAPL/NAPU) today announces positive clinical data on the effectiveness of crofelemer from a study for CRO-ID in treating severely ill cholera patients in conjunction with an antibiotic and rehydration therapy.
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A double-blind placebo-controlled study was conducted in one hundred (100) patients with confirmed severe cholera. Patients were randomized to placebo or 125 mg crofelemer every 6 hours or 250 mg crofelemer every 6 hours in a 1:2:2 randomization scheme. This single center trial was conducted at the International Centre for Diarrhoeal Disease Research (ICDDR, B) in Dhaka, Bangladesh, popularly known as the "cholera hospital" for the state-of-the-art treatment of cholera patients.
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The purpose of the trial was to obtain a therapeutic proof-of-concept in the treatment of cholera, by a reduction in the life-threatening fluid loss characteristic of cholera infection. In addition to receiving crofelemer, all patients received a single oral dose of azithromycin and rehydration therapy. These severely ill cholera patients, even when receiving the antibiotic azithromycin and rehydration therapy (but not crofelemer), averaged approximately 8.5 liters of stool volume output during the first 24 hour period. The primary endpoint in this study was the reduction in stool volume output normalized to the body weight of the cholera patients.



Following the exclusion of three outlier patients, the data demonstrates that a crofelemer dose of 125 mg every 6 hours reduced the amount of stool volume output normalized to body weight by 32% (p=0.028, Mann-Whitney test) in the first 6 hour period (0-6 hours). A 31% reduction in normalized stool volume output was also observed during the first 12 hour period (0-12 hours) with crofelemer 125 mg every 6 hours (p=0.072, Mann-Whitney test). The higher dose of crofelemer (250 mg every 6 hours) also showed a trend towards significance in the first 12 hour period (0-12 hours, p=0.155, Mann-Whitney test). Crofelemer was well tolerated in cholera patients. Crofelemer was safely and effectively used in combination with the antibiotic, azithromycin, and rehydration therapy.



Both Napo and ICDDR, B, upon receipt of additional funding, would like to continue with studies ranging to lower dosing regimens with crofelemer, and also include the treatment of children with development of a pediatric formulation of the product.



Elements of the cholera study in Bangladesh were funded by the National Institutes of Allergy and Infectious Disease.



Napo is currently conducting a Phase 3 trial for crofelemer for chronic diarrhea in people living with HIV/AIDS ("CRO-HIV"). This indication has been fast-tracked by the FDA. Napo expects to file its first NDA around mid-2009 for this indication, subject to the receipt of further funding.



Dr. Pradip Bardhan, Scientist and Head of Special Care Unit at ICDDR, B and the principal investigator, commented that "Crofelemer produces an impressive reduction in stool volume output within the first 12 hour period. There is a clear need for new agents to produce reduction in stool volume output in the first 12-18 hours, which is the period where the patients are at maximum risk for dehydration. Both doses of crofelemer were well tolerated and no drug related adverse events were observed in the cholera patients in this study. As a novel antisecretory agent, crofelemer represents a complementary mechanism to existing standard-of-care treatment of cholera, which consists of administering rehydration therapy and antibiotics, with the inherent risk of resistance generation."



Lisa Conte, Napo's CEO, commented, "Napo is so pleased to be reporting this powerful clinical data relating to the treatment of one of the most extreme cause of secretory/watery diarrhea with crof
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