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Jaguar Health Announces Submission of Investigational New Drug (IND) Application to FDA for Drug Candidate for the Symptomatic Relief of Diarrhea from Cholera
Jaguar is concentrating financial and management resources on two near-term late-stage clinical eventsSAN FRANCISCO, CA / ACCESSWIRE / August 30, 2022 /
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Jaguar is concentrating financial and management resources on two near-term late-stage clinical eventsSAN FRANCISCO, CA / ACCESSWIRE / August 30, 2022 / Jaguar Health, Inc. (NASDAQ:JAGX) (\"Jaguar\" or the \"Company\") today announced the submission by the Company's wholly owned subsidiary, Napo Pharmaceuticals (Napo), of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration for Napo's NP-300 drug product candidate for the symptomatic relief of diarrhea from cholera.\"I am very pleased that we have submitted the IND to FDA for the proposed cholera-related diarrhea indication for NP-300,\" said Steven King, PhD, Jaguar's Chief Sustainable Supply, Ethnobotanical Research & IP Officer. \"NP-300 and crofelemer have a similar physiological anti-secretory mechanism of action to reduce chloride ion secretion into the gut lumen and improve stool consistency. The Company has previously presented Phase 2 data on crofelemer for the treatment of devastating dehydration in cholera patients from the renowned International Centre for Diarrhoeal Disease Research (icddr,b) in Bangladesh.\"Upon approval of NP-300 for the symptomatic relief of diarrhea from cholera, the Company intends to pursue a Tropical Disease Priority Review Voucher (\"TDPRV\") under the FDA's financial incentive program to develop NP-300 for this indication. Priority review vouchers are transferable, and in past transactions by other companies have sold for values ranging from $67 million to $350 million, which provides for a potential immediate return on investment upon approval of NP-300 for the cholera-related diarrhea indication.As part of a $6.0 million financing agreement with Streeterville Capital, LLC (Streeterville) in 2021, providing Streeterville the right to 18% of the gross proceeds from the sale of a possible TDPRV, Jaguar was previously subject to a requirement to initiate a Phase 1 clinical trial of NP-300 for the cholera-related diarrhea indication by September 30, 2022.\"With this IND filed, the Company is well positioned to initiate the clinical program for the cholera-related diarrhea indication when our development team has the resources and bandwidth to make this indication a core focus. In this difficult market for early-stage drug development funding, Jaguar is focusing resources and effort on the near-term late-stage ...