Napo Pharmaceuticals, Inc. ("Napo"), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo's NP-300, a novel drug product candidate for the symptomatic relief and treatment of moderate-to-severe diarrhea, with or without concomitant antimicrobial therapy, from bacterial, viral and parasitic infections including Vibrio cholerae, the bacterium that causes cholera.
"We were very pleased to hear from the FDA that they have completed their review of our IND application for NP-300 and concluded that Napo may proceed with its proposed phase I clinical trial for the drug. Following the completion of the phase I trial, the Company will be positioned to initiate the next stage of our clinical development program for cholera-related diarrhea when our development team has the requisite resources and bandwidth to initiate the additional required trials," said Lisa Conte, Jaguar's president and CEO. "We are grateful for the partial financial support from the National Institute of Allergy and Infectious Diseases (NIAID) to support the NP-300 preclinical program."