Jaguar Health Subsidiary Receiving Preclinical Services from the National Institute of Allergy and Infectious Diseases for New Preclinical Study Initiated January 6, 2021 for Lechlemer Plant-Based Drug Candidate for the Symptomatic Relief of Diarrhea from Cholera
Lechlemer development focused on possible tropical disease priority review voucher
As previously announced, Napo is receiving preclinical services from the
"We are grateful for NIAID's support to conduct this important 28-day toxicity and safety study in dogs, which is expected to support the Investigational New Drug (IND) application we plan to file for lechlemer," stated
The Company believes that lechlemer, which has the same mechanism of action as crofelemer and is significantly less costly to produce, may support development efforts to receive a priority review voucher from the FDA for an indication for the symptomatic relief of diarrhea from cholera. Priority review vouchers are granted by the FDA as an incentive to develop treatments for neglected diseases and rare pediatric diseases. Priority review vouchers are transferable and, in past transactions by other companies, have sold for prices ranging from
Cholera is an acute diarrheal illness caused by infection of the intestine with the bacterium Vibrio cholerae. According to the
Lechlemer is a drug candidate under the botanical guidance of the
The Company has previously presented Phase 2 data on crofelemer for the treatment of devastating dehydration in cholera patients from the renowned
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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's belief that the preclinical 28-day toxicity and safety study in dogs will support the IND application the Company plans to file for lechlemer, the expectation that lechlemer may support efforts to receive a priority review voucher from the FDA for a cholera indication, the Company's belief that lechlemer represents a long-term pipeline opportunity as a second-generation anti-secretory agent, on a global basis, for multiple gastrointestinal diseases - especially in resource-constrained countries, and statements regarding Napo's plans for the study design for lechlemer. 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.