Crofelemer, First-in-Class Anti-Diarrheal Agent, Positive Clinical Results to be Discussed at 13th Annual US-Japan CMSP in Kolkata, India

OUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Napo Pharmaceuticals, Inc., (“Napo”) announces that oral presentations regarding the safety, efficacy and mechanism of action of crofelemer in clinical trials in severe acute dehydrating watery diarrhea and cholera, as well as the preclinical results for other small molecule cystic fibrosis transmembrane conductance regulator (CFTR) chloride channel blockers, will be presented at the upcoming U.S. - Japan CMSP: 13th International Conference on Emerging Infectious Diseases (EID) in the Pacific Rim – Focused on Enteric Diseases, April 6-9 in Kolkata, India. Data will also be presented on other pre-clinical anti-secretory agents. Glenmark Pharmaceuticals Limited (“Glenmark”) is currently undertaking clinical trials on crofelemer in India and anticipates introduction in the country in 2010. Glenmark has both developmental and marketing rights for the molecule in 140 countries around the world including India.

Pradip K. Bardhan of the International Center for Diarrheal Disease Research (“ICDDR”) in Bangladesh will be summarizing the results from two clinical studies that evaluated the safety and efficacy of Napo’s novel anti-secretory anti-diarrheal agent, crofelemer (NP-303), in the treatment of adult acute infectious diarrhea (conducted in India by Glenmark) and cholera (conducted at the ICCDR in Bangladesh). The study of the effects of crofelemer in adult infectious diarrhea, predominantly from enterotoxigenic Escherichia coli (ETEC) infection, was conducted without the use of any antibiotics, while the study in adult patients suffering from cholera infection was conducted in combination with a single oral dose of azithromycin. These results collectively show that crofelemer represents a first-in-class treatment option as an antisecretory agent for the treatment of acute dehydrating watery diarrhea, with or without the use of antibiotics.

Perhaps the most important application of crofelemer is to address the devastating morbidity and mortality of ~2.5 million children under 5 who die each year primarily in developing countries, from the devastation of diarrhea and dehydration of cholera and watery diarrhea due to multiple etiologies and the global crisis in access to clean water. Cholera, for example, results in death for >50% of its victims without adequate rehydration. Current standard-of-care therapy focuses on rehydration therapy and antibiotic therapy to target the infectious agent. There are no current therapies for cholera which decrease the secretion of fluid into the small intestine. Patients are at maximum risk during the first 6-18 hours. Crofelemer demonstrated significant reduction (approximately 32%) in stool volume output in the first 6 hours, a trend which continued through the first 24 hours of observation — the period of time where patients are often in a life-threatening situation due to severe dehydration. In the severe acute watery diarrhea study, overall clinical success was achieved in about 75% of the crofelemer group, including statistically significant results on all seven measurements of diarrhea symptoms. Both these studies was conducted in adults.

A separate presentation will be given by Dr. Alan S. Verkman of the Departments of Medicine and Physiology at the University of California, San Francisco, California, discussing the mechanism of action of crofelemer as a first-in-class, small molecule dual inhibitor of CFTR chloride channel and calcium activated chloride channel (“CaCC”). Furthermore, this presentation will provide some of the preclinical results with other novel small molecule inhibitors of CFTR (“second gen CFTR”), which have been exclusively licensed by Napo from the University of California regents.

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Lisa A. Conte, CEO of Napo Pharmaceuticals, Inc. commented: "Napo is thrilled that the important results of the trials of crofelemer for cholera and for severe adult acute infectious diarrhea are being presented in such a forum and I would like to thank Glenmark, Dr. Bardhan and the ICDDR for their contributions. We look forward to Glenmark’s anticipated introduction of crofelemer in India in 2010 and in other countries thereafter. Napo is committed to the development of crofelemer for pediatric populations and collaboration with both crofelemer and second gen CFTR to address the global impact of diarrhea diseases.”

Napo’s commercial licensee for crofelemer in the United States, Salix Pharmaceuticals, Inc., expects to file an NDA for the indication of chronic diarrhea in people living with HIV/AIDS in the first half of 2010. Crofelemer is in the final Phase 3 study for this indication and has been fast-tracked by the FDA.