SAN FRANCISCO, CA / ACCESSWIRE / July 11, 2019 / Jaguar Health, Inc. (NASDAQ: JAGX) (“Jaguar” or the “Company”), a commercial stage pharmaceutical company focused on developing novel, sustainably derived gastrointestinal products on a global basis, announced today that its wholly owned subsidiary, Napo Pharmaceuticals, Inc., has agreed in principal to support a U.S.-based University’s request to begin an - Institution Initiated Clinical Research Study. The University will perform a pilot study to evaluate the safety and effectiveness of crofelemer for treatment of chronic idiopathic diarrhea in non-HIV patients (the “Study”). The Study has received approval from the University’s Institutional Review Board, and Napo Pharmaceuticals, Inc. is currently negotiating the definitive agreement with the University.
Chronic idiopathic diarrhea is a common complaint of patients presenting to family practitioners, internists and is one of the most common reasons for referral to gastroenterologists. It is estimated that the prevalence of chronic idiopathic diarrhea in developed countries (including the U.S.) is approximately 3-5%. It has a significant negative effect on health-related quality of life and causes a high economic burden on patients and society. The American Gastroenterological Association Burden of Illness study (2012) showed that the estimated annual direct and indirect costs associated with chronic idiopathic diarrhea is up to $524 million per year and $136 million per year, respectively.
The planned open-label pilot study will assess the efficacy of crofelemer during a 28-day treatment period in adult, non-HIV patients with chronic idiopathic diarrhea. The study has an expected duration of one year.
Crofelemer, the active pharmaceutical ingredient being tested, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas.
For more information about Jaguar, please visit jaguar.health. For more information about Napo, visit napopharma.com.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that University will perform a pilot study to evaluate the safety and effectiveness of crofelemer for treatment of chronic idiopathic diarrhea in patients. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Jaguar Health, Inc.
SOURCE: Jaguar Health, Inc.