SAN FRANCISCO, Oct. 30 /PRNewswire/ -- Napo Pharmaceuticals, Inc., , which focuses on bringing proprietary products to the global marketplace in collaboration with local partners, is pleased to announce today that Trine Pharmaceuticals, Inc. ("Trine") (Waltham, Mass, USA), has initiated enrollment in a Phase 2b study evaluating the efficacy and safety of Napo's lead product candidate, crofelemer, a natural product sustainably harvested from the rain forest, for the treatment of female patients suffering from diarrhea-predominant irritable bowel syndrome (D-IBS). Trine has worldwide development and commercialization rights to crofelemer for the IBS indication. Within thirty (30) days following the initiation of this study, Trine will pay Napo a milestone payment of USD $1 million.
This multi-center, randomized, double-blind, placebo-controlled study is expected to enroll approximately 240 women in the U.S. who have D-IBS. The primary endpoint of this study will be the improvement of abdominal pain associated with D-IBS.
Commenting on this announcement, Ms Lisa Conte, Chief Executive Officer of Napo Pharmaceuticals Inc, said: "We are delighted to have announced the initiation of this key Phase 2b study in diarrhea-predominant irritable bowel syndrome (D-IBS), for which we will receive a $1 million milestone payment from our partner, Trine. With the activity observed in the phase 2a study and the risk mitigation provided by leveraging an extensive safety database of over 1,500 patients involved in clinical testing of crofelemer across four indications, we have high expectations for this new trial."
IBS is characterized by a constellation of gastro intestinal symptoms, including diarrhea, constipation (or alternation of the two), urgency and abdominal pain. IBS may affect up to 20 percent of the population in the U.S. (estimates range from 15-20 percent; of whom 70 percent are women). More than 60 percent of the affected patients are managing either diarrhea predominant IBS or alternation IBS. It ranks second only to the common cold as a cause of lost work time in the U.S. In addition, the disease accounts for approximately 3 million physician visits in the U.S. each year, costing the U.S. economy an estimated USD $30 billion annually. The global market could be over USD $15 billion for a safe and effective D-IBS product. The market for D-IBS is largely unserved due to serious toxicities associated with black-box restrictions of GlaxoSmithKline's Lotronex, approved for the treatment of D-IBS in women.
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 AIDS diarrhea, Phase 3
* CRO-IBS for diarrhea irritable bowel syndrome ("D-IBS"), Phase 2
* CRO-ID for acute infectious diarrhea (including cholera), Phase 2
* CRO-PED for paediatric diarrhea, Phase 1
For more information please contact:
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. Napo also plans to develop a preclinical product, NP-500, for the treatment of insulin-resistant diseases of Type II diabetes and Syndrome X. Napo also has a plant library of approximately 2,300 medicinal plants from tropical regions and Napo has entered its first screening relationship associated with this collection. Currently, products are based on the chemical and biological diversity derived from plants with medicinal properties, but future products may be in-licensed from other sources.
Napo has partnerships with Trine Pharmaceuticals, Inc., of the United States of America; Glenmark Pharmaceuticals Limited of India; and AsiaPharm Group Ltd. of China. For more information please visit www.napopharma.com .
Napo Pharmaceuticals, Inc
Lisa Conte, Chief Executive Officer + 650 616 1902
Charles Thompson, Chief Financial Officer + 650 616 1903
David Schull + 858 546 4810
Tim Anderson, Mary-Jane Johnson 020 7466 5000
Nomura Code Securities Limited
Juliet Thompson 0207 776 1204
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Napo Pharmaceuticals, Inc.