Jaguar Health Announces Study to Evaluate the Safety and Effectiveness of Crofelemer for Treatment of Chronic Idiopathic Diarrhea in Non-HIV Patients
SAN FRANCISCO, CA / ACCESSWIRE / December 16, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) announced today that a clinical research study initiated and sponsored by The University of Texas Health Science Center at Houston (UTHealth) will be supported by Jaguar’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (“Napo”). The study will evaluate the safety and effectiveness of crofelemer for treatment of chronic idiopathic diarrhea in patients (the “Study”). The Study is expected to begin enrolling patients in the fourth quarter of 2019. Crofelemer (Mytesi®) is the Company’s FDA-approved orally administered botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest.
Chronic idiopathic diarrhea is a common complaint of patients presenting to family practitioners and 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 primary objective of the Study will be to evaluate the safety and efficacy of crofelemer in patients with chronic idiopathic diarrhea. Adult patients with a diagnosis of noninfectious chronic idiopathic diarrhea (defined as >20 bowel movements per week of which >50% are watery bowel movements) will be included in the Study. Subjects will receive crofelemer (Mytesi) 125 mg delayed-release tablets twice daily, with or without food for four weeks. Reduction in weekly stool frequency as well as changes in stool consistency and quality of life improvements will be evaluated at the end of the Study.
The principal investigator for the Study will be Dr. Brooks D. Cash, MD, AGAF, FACG, FACP, FASGE, Chief - Division of Gastroenterology, Hepatology and Nutrition, Sterling Professor of Medicine, McGovern Medical School at UTHealth, Co-Director, Ertan Digestive Disease Center at Memorial Hermann-Texas Medical Center. The Study is titled Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients: A Pilot Study, and is a single-center trial at UTHealth.
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.
Certain statements in this press release constitute “forward-looking statements.” 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.
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