Jaguar Health Announces Submission of Clinical Trial Applications for Crofelemer for the Rare Disease Indications Microvillus Inclusion Disease (MVID) and Short Bowel Syndrome (SBS) in Europe

Jaguar's novel plant-based prescription drug crofelemer has been granted Orphan Drug Designation by the FDA and the European Medicines Agency for both MVID and SBS

SAN FRANCISCO, CA / ACCESSWIRE / May 9, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that Jaguar family companies Napo Pharmaceuticals ("Napo") and Napo Therapeutics have submitted a Clinical Trial Application (CTA) to the Italian and German health authorities to initiate a phase 2 clinical trial of Jaguar's novel plant-based prescription drug crofelemer for treatment of short bowel syndrome (SBS) with intestinal failure in adults. Napo Therapeutics has also submitted a CTA to AIFA, the Italian health authority, for the conduct of a clinical trial in pediatric patients with microvillus inclusion disease (MVID), and the approval request process is also underway for this trial in the United Arab Emirates with Dubai Health. The MVID clinical trial is being conducted under an active US Investigational New Drug (IND) in the US.

"We're very pleased that these important CTAs have been submitted," said Lisa Conte, Jaguar's president and CEO. "This is a key regulatory milestone in our ongoing development efforts for a novel powder formulation of crofelemer for oral solution for patients with MVID and SBS with intestinal failure - two devastating and often catastrophic rare diseases for patients, who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week."

"As previously announced, Jaguar, with strong leadership and participation from Napo Pharmaceuticals and Napo Therapeutics, is also supporting investigator-initiated proof-of-concept studies of crofelemer for MVID and SBS with intestinal failure in the US, EU and Middle East/North Africa (MENA) regions, with proof-of-concept results expected in 2024. Additionally, in August 2023 the FDA activated Napo Pharmaceuticals' Investigational New Drug (IND) application for a novel formulation of crofelemer for the treatment of MVID, which allows us to initiate our planned US-based phase 2 trial of crofelemer for treatment of this indication in pediatric MVID patients," Conte said. "In accordance with the guidelines of specific EU countries, published data from clinical investigations in MVID and SBS could support early patient access to crofelemer for these debilitating conditions in those countries."