SAN FRANCISCO--(BUSINESS WIRE)--Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar), a commercial stage natural-products pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products for both human prescription use and animals on a global basis, announced today that Dr. Roscoe Moore Jr., DVM, MPH, Ph.D., DSc has joined the HIV Scientific Advisory Board recently established by Jaguar’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc. (Napo), for Mytesi® (crofelemer), Napo’s FDA-approved, first-in-class anti-secretory human prescription drug.
Napo’s HIV Scientific Advisory Board will focus primarily on physician education, and community and global awareness regarding the importance and availability of solutions for neglected comorbidities, such as the first-in-class anti-secretory mechanism of action of Mytesi® for its currently approved indication.
Launched by Napo in October 2016, Mytesi® is the only antidiarrheal studied in and U.S. FDA-approved for the symptomatic relief of noninfectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is a prescription treatment for diarrhea that works differently, by acting locally in the GI tract to normalize the flow of water. Mytesi® does not have drug-drug interactions with ART, does not affect GI motility, and has side effects that are similar to placebo.
According to data from The Joint United Nations Programme on HIV/AIDS (UNAIDS), approximately 36.7 million people globally were living with HIV in 2016, of which an estimated 19.5 million people were accessing antiretroviral therapy—up from approximately 17.1 million in 2015 and an estimated 7.7 million in 2010—and approximately 1.8 million people became newly infected with HIV in 2016.
Dr. Moore is a former Assistant United States Surgeon General and a Rear Admiral (Retired) in the U.S. Public Health Service. Dr. Moore was involved in the creation of PEPFAR (the U.S. President's Emergency Plan for AIDS Relief). PEPFAR was launched in 2003 by President George W. Bush, and is dedicated to fighting HIV/AIDS in developing nations. The organization is credited with saving millions of lives by expanding access to HIV prevention, care and treatment in low-resource settings. Of the approximately $6.80 billion appropriated to PEPFAR for fiscal year 2017, $5.21 billion is allocated for HIV.
Dr. Moore served in the Office of the US Secretary of Health and Human Services (HHS), and operated as Principal Liaison between the HHS and Ministries of Health in Africa with regard to the development of infrastructure and technical support for the delivery of preventive and curative health needs for the continent. He also served as chief epidemiologist with the FDA’s Center for Devices and Radiological Health, and as the ranking veterinarian across all of the uniformed services, including the armed forces. Dr. Moore has taken leadership roles in the surveillance of emerging and re-emerging diseases worldwide, bioterrorism issues, and the safety of bioengineered foods. He has written or co-authored more than 100 publications covering a broad range of public health issues. Dr. Moore founded PH RockWood Corporation and serves as its President, and he serves as the CEO of Medical Security Incorporated. He also serves as a board member, director, or advisor for a number of companies in the health field. Dr. Moore holds a Ph.D. in Epidemiology from The Johns Hopkins University, an M.P.H. in Epidemiology from the University of Michigan, and a Doctor of Veterinary Medicine and a B.S. degree from Tuskegee Institute.
“Neglected comorbidities such as HIV-related diarrhea play a significant role in patient adherence to ART. Although ART failure or success is based on a number of factors, including genetic differences in drug metabolism, prior drug resistance, severe baseline immune suppression, and concurrent opportunistic infections, ART adherence is of critical importance because is it one of the few potentially alterable factors determining outcomes for HIV patients,” Dr. Moore stated. “Efforts to expand awareness about available solutions, such as Mytesi®, that address specific comorbidities play an important role in maximizing health and wellness in this population.”
“We are very honored that Dr. Moore—a globally recognized leader in the field of human health and HIV—has joined Jaguar’s HIV Scientific Advisory Board,” Lisa Conte, Jaguar's president and CEO, stated. “We expect Dr. Moore’s expertise and decades of experience in the HIV field to prove immensely beneficial as we work to grow awareness among physicians and the HIV community regarding the first-in-class anti-secretory mechanism of action of Mytesi® for its currently approved indication.”
Dr. Pravin Chaturvedi, chair of Napo’s scientific advisory boards, added, “We are greatly pleased that Dr. Moore has joined our scientific advisory board for HIV. He brings a wealth of experience, and we look forward to leveraging his insights and 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.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products for both human prescription use and animals 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. 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. Mytesi® is in development for multiple possible follow-on indications, including cancer therapy-related diarrhea; orphan-drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome; supportive care for inflammatory bowel disease (IBD); irritable bowel syndrome (IBS); and as a second-generation anti-secretory agent for use in cholera patients. Canalevia™ is our lead animal prescription drug candidate, intended for treatment of various forms of diarrhea in dogs. Equilevia™ is Jaguar’s non-prescription product for total gut health in equine athletes. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are Jaguar’s lead non-prescription animal products. Mytesi®, Canalevia™, Equilevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals.
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that Dr. Moore’s expertise and decades of experience in the HIV field will prove immensely beneficial as Jaguar and Napo work to grow awareness among physicians and the HIV community regarding the first-in-class anti-secretory mechanism of action of Mytesi® for its currently approved indication, and about planned, potential follow-on indications for Mytesi®. 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.