Jaguar Health completes FDA Type C meeting on crofelemer trial

Jaguar Health’s (JAGX) Napo Pharmaceuticals provided its assessment of the company’s Type C Meeting with the U.S. Food and Drug Administration 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, 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 in the UAE, along with its other advisors, participated in this meeting. “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 CSO. As stated above, the results of the ongoing investigator-initiated proof-of-concept trial in the UAE in a pediatric MVID patient demonstrate continued improvement of reduction of PS by 37% with a total parenteral nutrition reduction of 30%. This improvement has been observed since reinitiation of crofelemer oral dosing following the protocol-mandated drug cessation at 12 weeks. The weekly reductions in PS and TPN of 37% and 30% are higher than the previously reported PS reduction of 27% at 12 weeks in this patient.