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Jaguar Health Completes Meeting with FDA for Advice on Development Pathways to Advance Ongoing Crofelemer Trial for Potential Approval for Treatment of Pediatric Indication Microvillus Inclusion Disease (MVID)
Additional update: Results of ongoing investigator-initiated proof-of-concept trial in United Arab Emirates (UAE) demonstrate further reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) ...
About this update from Jaguar Health, Inc.
[{"type":"text","content":"Additional update: Results of ongoing investigator-initiated proof-of-concept trial in United Arab Emirates (UAE) demonstrate further reduction of total parenteral support (PS) (comprised of total parenteral nutrition and supplementary IV fluids) of approximately 37%","length":267,"tagName":"p"},{"type":"text","content":"SAN FRANCISCO, CA / ACCESS Newswire / October 6, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today provided its assessment of the company's Type C Meeting with the U.S. Food and Drug Administration (FDA) on October 2, 2025 to seek their advice for efficient advancement of the company's clinical trial of its novel crofelemer powder formulation for oral solution for the treatment of microvillus inclusion disease (MVID), an ultrarare pediatric disorder. Members of Napo's Scientific Advisory Board, including a key opinion leader who is the principial investigator for the ongoing open-label investigator-initiated trial (IIT) in the UAE, along with its other advisors, participated in this meeting.","length":761,"tagName":"p"},{"type":"text","content":"MVID is a devastating pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities.","length":393,"tagName":"p"},{"type":"text","content":""The company appreciates the collaborative and interactive discussion with the FDA. In our assessment, there may be potential opportunities to advance the development program for our ongoing MVID study to support approval of crofelemer for this indication. The company will continue its interactions with the FDA after making selected amendments to this clinical study. Upon agreement with the FDA, this small and adequately well-controlled study may allow a pathway to address critical unmet medical needs of MVID patients in a manner that supports evaluation of the clinical meaningfulness of disease progression-modification and potential translation for an approved label," said Pravin Chaturvedi, PhD, Napo's and Jaguar's Chief Scientific Officer and Chair o...