Jaguar Health Engages Integrium, LLC to Support Clinical Study Evaluating the Effect of Mytesi on the Microbiome
Study will Examine the Possible Benefits of Mytesi® on Gut Health, Including Bloating and Abdominal Discomfort, in People Living with HIV
SAN FRANCISCO, CA / ACCESSWIRE / June 26, 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 the Company has entered into a Master Services Agreement ("the Agreement") with Integrium, LLC, a clinical research organization that designs, conducts, and analyzes clinical trials. Under the terms of the Agreement and the associated service order, Intergrium will provide clinical development services to Jaguar's wholly-owned human-health subsidiary, Napo Pharmaceuticals, Inc. ("Napo"), in support of a study to evaluate the effect of Mytesi® on the gastrointestinal microbiome in people living with HIV (PLWH).
Mytesi (crofelemer) is the Company's FDA-approved drug product indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART).
The planned study is specifically intended to evaluate changes in the microbiome of people living with HIV (PLWH) following oral treatment with crofelemer (Mytesi). The study is being undertaken to further understand the longer term attributes of symptomatic relief of diarrhea in PLWH receiving Mytesi. Since the microbiome is an important contributor to gut health, the evaluation of changes in the microbiome in PLWH who experience symptomatic relief from diarrhea is expected to allow further insights into Mytesi's effects on gut health, including but not limited to the possible beneficial effects of Mytesi on diarrhea-related symptoms such as bloating and abdominal discomfort.
This study is being funded by an investment in Jaguar by California-based PoC Capital, LLC, which focuses on investing in small, public life science companies whose product candidates PoC Capital believes have the opportunity to improve patient well-being.
"We look forward to adding microbiome data to our overall understanding of the gut health of Mytesi patients, especially as we work towards expanding Mytesi access to new groups of patients who need symptomatic relief of non-infectious diarrhea," Lisa Conte, Jaguar's president and CEO, stated.
Daron Evans, Managing Director of PoC Capital, LLC, commented, "We are excited to help fund Jaguar's efforts to expand their body of clinical evidence support for Mytesi's use in patients living with HIV. In the long run, we believe many other patients could benefit from Mytesi, including patients on chemotherapy and other drug regimens that can induce diarrhea."
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%).
See full Prescribing Information 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 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. 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.
About Intergrium, LLC
Integrium is a full-service clinical proof of concept (PoC) firm focused within the therapeutic areas of cardiovascular, metabolic, renal, inflammatory, dermatology, wound healing, regenerative, microbiome and orphan disease. Although we have the scientific, medical, operational, and regulatory expertise to cover all stages of clinical development (Phase I-IV), we are experts in the strategy, design and execution of clinical PoC trials.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's plan to conduct a clinical study evaluating the effect of Mytesi on the microbiome in PLWH, the expectation that the evaluation of changes in the microbiome in PLWH who experience symptomatic relief from diarrhea will allow further insights into Mytesi's effects on gut health, the belief that the Company's product candidates have the opportunity to improve patient well-being, statements related to efforts to expand Mytesi access to new groups of patients who need symptomatic relief of non-infectious diarrhea, and the belief that many other patients could benefit from Mytesi, including patients on chemotherapy and other drug regimens that can induce diarrhea. 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.