Public HealthNapo Participation In Call To Action To Prevent Deaths From Diarrheal Diseases In Children Under Five Years Of Age
Napo Pharmaceuticals, Inc. ("Napo") is proud to announce that the Company is part of the Call to Action led by PATH, UNICEF, and WHO to raise the visibility of diarrheal disease and solutions to address it. The Call to Action includes the invitation to "invest in the research and development of new effective, appropriate and affordable prevention and treatment options for diarrheal disease."
Napo"s drug development efforts should come as welcome news for all those supporters of such a call to action and to those who suffer from the immense mortality and morbidity imposed on children from diarrheal diseases. Recent clinical trial results show that Napo"s lead drug candidate, crofelemer, is effective in limiting the life threatening dehydration associated with severe cholera and severe watery diarrhea of multiple causes. Crofelemer has a novel anti-secretory mechanism of action, which, because it targets a "downstream" mechanism of normalizing ion flow and water flow into the intestines without affecting normal gut motility, can be used effectively and safely: (i) regardless of the cause of the secretory diarrhea; (ii) without the risk of emerging antibiotic resistance; (iii) in conjunction with other therapies (in fact, without drug-drug interactions); and, (iv) in both acute and chronic situations. While the World Health Organization ("WHO") advocates against the use of currently available anti-diarrheals in children due to lack of safety, crofelemer has so far safely been tested in ~1800 patients, including children as young as 3 months of age, without any drug-related adverse events. Crofelemer acts locally in the gut with no or minimal systemic exposure to the patient.
Crofelemer is in Phase 3 testing for chronic diarrhea in people living with HIV-AIDS (US) and adult acute infectious diarrhea, including cholera (India, Bangladesh, Jamaica, and Mexico). The first product approval in adults is expected in mid-2010. Napo is organizing a program to accelerate the development and approval of a pediatric formulation of crofelemer targeting approval in 2011-2012 (pending additional funding), including the establishment of a global advisory board to ensure that the development program for an FDA approved pediatric product incorporates the current WHO guidelines for oral rehydration solution ("ORS"), zinc, and other guidelines for Essential Medicine treatment of diarrheal disease and to generate a formulation that is practical and safe for re-constrained regions with limited healthcare-trained personnel.
Diarrheal disease is the most common cause of illness and the second leading cause of child death in the world, ~2 million each year. The UN Millennium Goal 4 ("MG4") to reduce by 2015 the number of deaths in children About Napo Pharmaceuticals, Inc.
Napo Pharmaceuticals, Inc. focuses on the development and commercialization of proprietary pharmaceuticals for the global marketplace in collaboration with local partners. Napo was founded in November 2001, and is based in California, USA with a subsidiary in Mumbai, India.
Napo"s late-stage proprietary gastro-intestinal compound, crofelemer, is in various stages of clinical development for four distinct product indications, including a late-stage Phase 3 program:
- CRO-HIV for HIV-related diarrhea, Phase 3 (under a Special Protocol Assessment)
- CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2
- CRO-ID for acute infectious diarrhea (including cholera), Phase 2
- CRO-PED for pediatric diarrhea, Phase 1
The FDA has granted fast-track status to CRO-IBS and CRO-HIV.
Crofelemer, a proprietary patented agent, is extracted from Croton lechleri, a medicinal plant which can be sustainably harvested from several countries in South America. Crofelemer is a first-in-class anti-secretory agent. Napo holds the exclusive worldwide rights to novel small molecule potential second generation anti-secretory agents, which have been licensed by Napo from the University of California regents.
Napo is developing an early clinical stage/ready for Phase 2 product, NP-500, for the treatment of insulin resistant diseases of Type II diabetes and metabolic syndrome (Syndrome X; pre-diabetic syndrome). Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions, and the company has entered two screening relationship associated with this collection.
For more information please visit http://www.napopharma.com.
Napo Pharmaceuticals, Inc.