SAN FRANCISCO, CA / ACCESSWIRE / May 26, 2021 / Napo Pharmaceuticals Inc., the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company"), announced today the appointment of Darlene Horton, M.D., a biopharmaceutical veteran and leading clinical development expert, to the role of Chief Medical Officer (CMO) for Napo.
"We are thrilled that Darlene is bringing her strong clinical experience together with deep industry experience and operational leadership, which will support Napo's ongoing phase 3 clinical trial with crofelemer for prophylaxis of diarrhea in adult cancer patients receiving targeted cancer therapy ("cancer therapy‑related diarrhea" (CTD))," said Pravin Chaturvedi, PhD, Napo/Jaguar Chair, Scientific Advisory Board and acting Chief Scientific Officer. "Darlene has a deep background in drug development, and her leadership and stewardship will augment our ongoing clinical studies for CTD as well as other planned indications."
Dr. Horton brings 25 years of clinical research and development, medical affairs, senior executive, and consulting experience in the development of investigational and commercialized biopharmaceutical and drug-device combination products. She has extensive clinical development experience in multiple therapeutic areas including cardiology, oncology, immunology, orthopedics, gastroenterology, women's health, and endocrinology. Prior to joining Napo, she led clinical development and regulatory strategy as CMO at Coherus Biosciences, Itero Biopharmaceuticals, and SMC Biotechnology. As Head of Clinical and Medical Affairs at Scios, she led the clinical development program that led to the approval of Natrecor® and was on the senior executive team when Scios was acquired by JNJ for $2.4B. At JNJ, she co-led (with strategic marketing) the cardiovascular therapeutic area when JNJ in-licensed and began developing the blockbuster drug Xarelto®. She also served as CEO at Nile Therapeutics and TulangCo Inc. Dr. Horton completed her Pediatric Cardiology fellowship and Pediatrics Residency at UCSF. She holds M.D. and B.S. in Microbiology degrees from the University of Florida.
"I am very excited to join Napo at this important time, when both our lead CTD program and efforts to pursue conditional marketing authorization from the European Medicines Agency for crofelemer through Napo EU are underway," said Dr. Horton. "I believe crofelemer's novel mechanism of action has the potential to benefit multiple gastrointestinal disorders. I am delighted to be partnering with the experienced Napo and Jaguar leadership teams and look forward to helping the Company expand access to crofelemer."
Mytesi (crofelemer) is a non-opiate, plant-based, chloride ion channel modulating antidiarrheal medicine that is FDA approved for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS receiving antiretroviral therapy. The only oral plant-based prescription medicine approved under FDA Botanical Guidance, Mytesi has a novel mechanism of action that works locally in the gut by gently and effectively modulating and normalizing the flow of water and electrolytes with minimal systemic absorption.
About Jaguar Health, Inc. and Napo Pharmaceuticals, Inc.
Jaguar Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for people and animals with GI distress, specifically chronic, debilitating diarrhea. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest areas. Our Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.
Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, 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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the belief that Dr. Horton's leadership and stewardship will augment Napo's ongoing clinical studies for CTD as well as other planned indications, and the belief that crofelemer's novel mechanism of action has the potential to benefit multiple gastrointestinal disorders. 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.