Jaguar Health Subsidiary Napo Pharmaceuticals Establishes Scientific Advisory Boards for Planned Follow-on Indications for Mytesi, Napo’s FDA-approved Human Prescription Drug
Leading Medical Oncologist and Hematologist Dr.
Mytesi® is approved by the
Napo has identified more than 30 physicians, pharmacists and patient advocates around the world who are recognized specialists and key opinion leaders in the planned Mytesi® follow-on indications listed above, and is conducting outreach efforts to discuss the possibility of membership in Napo’s new scientific advisory boards with these individuals.
Napo has also established a scientific advisory board for HIV. This board will focus primarily on physician education and community 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.
“Diarrhea remains an area of concern for patients undergoing cancer treatment. In this era of novel targeted agents, epidermal growth factor receptor tyrosine kinase inhibitors (TKIs), in particular, may block natural chloride secretion regulation pathways in the normal gastrointestinal mucosa, thereby leading to secretory diarrhea,” Dr. Schwartzberg commented. “Diarrhea has been reported as the most common side effect of the recently approved CDK 4/6 inhibitor abemaciclib and the pan-HER TKI neratinib, with occurrence ranging from 86% to >95% in published studies. Diarrhea in this patient population has the potential to cause dehydration, potential infections, and non-adherence to treatment. A novel anti-diarrheal like Mytesi® may hold promise for treating secretory diarrhea—and therefore also support long-term cancer treatment adherence—in this population.”
Dr. Schwartzberg was the founding editor-in-chief of the journal Community
Oncology and currently serves as the editor-in-chief of the Practice
Update Oncology website. He serves on the editorial board of both the
“We are confident that our scientific advisory boards will provide
expert, actionable input regarding all aspects of development, including
trial design, for Mytesi® for our follow-on indications—each
of which addresses a significant, global, unmet medical need—and we are
extremely pleased and honored that an oncologist and hematologist of Dr.
Schwartzberg’s stature has joined our scientific advisory board for
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
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding planned, potential follow-on indications for Mytesi®, the potential effectiveness of Mytesi® for treating CTD, and Jaguar’s and Napo’s belief that its scientific advisory boards will provide expert, actionable input regarding all aspects of development, including trial design, for potential Mytesi® follow-on indications. 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.
KCSA Strategic Communications
Garth Russell, 212-896-1250